2013
AMWA’s 73rd Annual Conference November 6-9, 2013 / Columbus, OH
EXPANDING OUR HORIZONS
Registration Brochure Register early and save at www.amwa.org www.amwa.org/events_annual_conference
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EXPANDING OUR HORIZONS
welcome
Join us AMWA’s
73rd Annual
Conference
November 6-9, 2013 / Columbus, OH
Whether you write or edit for the pharmaceutical industry, health care professionals, or lay audiences, participation in the 2013 AMWA Annual Conference will enhance your knowledge and professional skills. This year’s conference is packed with new session formats, an extended list of invited speakers, presentations on timely topics, and a host of networking events. This conference program is designed to provide you with an outstanding educational experience and opportunities that will enable you to move your career forward and help you achieve, and maintain, success in medical communication. Gain new skills and knowledge to enhance your expertise as a medical communicator or increase your current skill level. Take advantage of the information in this 2013 Annual Conference registration brochure by carefully reviewing all of the offerings to maximize your conference experience. If you attend only one conference this year, AMWA’s annual conference is your best value! AMWA’s budget-friendly annual conference offers many outstanding speakers at open sessions and workshops that give you a sound return on your investment. The basic registration fee includes access to two general sessions with award-winning speakers (a keynote and a closing general session), open sessions, exhibit hall, and expanded networking events, including ■ Wednesday evening Welcome Reception ■ Thursday Lunch ■ Thursday evening Networking Reception ■ Friday morning Networking Breakfast ■ Saturday afternoon Annual Business Meeting Lunch
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w r i t i ng
new this year Wednesday Start
If AMWA workshops are the primary reason you attend the conference, you can get a head start by taking a workshop on Wednesday afternoon. Participating in a Wednesday workshop increases your options because it can free up time for you to attend sessions on Thursday through Saturday. And because of the central location of this year’s conference, travel is easier, and you may not need to pay for an extra night at the hotel to take advantage of a Wednesday workshop. If you can’t arrive early, plenty of workshops are available through Saturday afternoon.
New Session Formats
The Intensive Seminar is among the new session formats developed this year, with a goal of creating a more robust learning experience outside the AMWA education program. Intensive Seminars are 2.5 hours long, cost a nominal fee, and have limited attendance to optimize interactivity, so be sure to sign up early! Other new session formats introduced at this year’s conference include Topic Seminars, 1-hour sessions that focus on critical issues, techniques, or processes; Hands-on Demonstrations, 30- or 60-minute sessions that enable you to practice as you learn; Encore Presentations, which feature presentations given at recent meetings of relevant organizations; Pro/Con Debates, 1-hour sessions that provide a lively discussion on two sides of an issue; and informal discussions focused on “lighter” topics and on addressing challenges in medical communication. Roundtable Lunches: Those of you who are not morning people will be happy to learn that we are offering the popular roundtable discussions over lunch as well as breakfast. That’s right, if your brain functions best later in
the day, sign up for a lunch roundtable, and leave the breakfast roundtables to the early risers.
Programming for Students
As a way to introduce students to the medical communication field, AMWA is planning sessions of particular interest to students on Saturday. Drawing students to the conference will help expose young writers and scientists to medical communication as a career and potentially increase our membership with a new generation of medical writers and editors.
Full Saturday Program
Many conference attendees leave on Saturday, but we’re giving you reasons to stay until Sunday! We know that after 3 days of sessions and workshops, some of you are looking to unwind a bit but still gain some interesting and useful information. Then Saturday afternoon is for you! We’re scheduling “soft topic” sessions for the last afternoon to help you spend some time without taxing your brain. This year, you will find the return of the Creative Readings—in a new time slot: Saturday afternoon. Of course, if you’d rather keep your nose to the grindstone, you can take one of several workshops that afternoon.
Sunday Fun
On Sunday, you can enjoy one of two special tours exclusively for AMWA conference attendees. Hop on a bus and take off for the renowned Columbus Zoo and Aquarium. Or, if you’re a foodie, lace up your sneakers and set off for a walking food tour of a nearby Columbus neighborhood. Either activity is a great way to end your conference experience and say good-bye to this great city and your colleagues.
Register early and save at www.amwa.org www.amwa.org/events_annual_conference
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ED i t i ng
contents
Educational Program Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Award Speakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Schedule at a Glance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Registration Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Hotel and Location Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Travel Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Full Program Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Wednesday. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Thursday . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Friday. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Saturday . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Sunday Tours. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 AMWA Certificate Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Annual Conference Committee. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 2012-2013 Executive Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 AMWA Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Sponsors and Exhibitors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
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career development
educational program information We tailor our programming to the profession and continually review our offerings to provide options for both new and experienced medical communicators. Our goal is to provide participants an opportunity to gain new skills and knowledge to enhance their expertise in the many facets of medical communication. AMWA’s move to soliciting proposals for all session types enabled us to develop a program with exceptional depth and breadth, with an emphasis on writing and editing, social media and technology, career development, business aspects of freelancing, and other relevant skills (eg, slide design, oral presentations, project management). Care has been taken to build a schedule that helps attendees participate in the most possible sessions on his or her preferred topic. AMWA’s 2013 Annual Conference offers more than 80 workshops and 70 open sessions. Workshops are 3-hour intensive, small group training programs designed to enhance the skills of medical communicators. Workshop participation requires an additional fee, and credit workshops are approved for credit toward an AMWA certificate. Earning an AMWA certificate is considered part of a career path in the field and is required by many employers. Certificate program details can be found beginning on page 66. A schedule and educational program list can be found beginning on page 14.
Important Information Regarding Workshop Participation ■
Register early if you plan to enroll in credit workshops, which often fill quickly. Space is assigned on a first-come, first-served basis, and credit workshops are limited to 30 participants. Advanced workshops are limited to 16 participants. (There is no limit for noncredit workshops.)
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All conference attendees are eligible to register for workshops regardless of whether they are pursuing an AMWA certificate. Workshop fees are the same whether or not the workshop is being taken for credit. Each registrant may take a maximum of four credit workshops per conference, including no more than three Advanced (ADV) workshops. There is no limit on the number of open sessions or noncredit workshops registrants can attend.
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Each credit workshop includes homework to be completed before the conference. Participants who intend to take workshops for credit should register on or before September 30, 2013. This deadline is to allow time for AMWA headquarters staff to send registrants their homework and time for registrants to complete the homework assignments and return them to the workshop leaders by the due date of October 15, 2013.
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So that all registrants for AMWA Advanced Workshops are prepared to participate in the discussions, each registrant must complete the homework and submit it to the workshop leader by the deadline, regardless of whether the registrant is taking the workshop for credit. If a registrant’s completed homework is not received by the deadline, he or she will not be allowed to attend the workshop, and no workshop credit or refund will be given.
Not an AMWA Member? You can still take advantage of the AMWA member rates for the conference. Just join AMWA on www.amwa.org and then register!
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ethics
award speakers Our line-up of invited speakers features the recipients of the AMWA Alvarez and McGovern Awards. AMWA is thrilled and honored to recognize two individuals for their outstanding contributions to medical communication.
AMWA Alvarez Award Winner Gregory D. Curfman, MD
Executive Editor of the New England Journal of Medicine Among Dr Curfman’s signature accomplishments is the development of the NEJM’s “Perspective” section, which spotlights issues in the health policy and health care reform arena.
AMWA McGovern Award Winner Cynthia Baur, PhD
Senior Advisor for Health Literacy, Office of the Associate Director for Communication, Centers for Disease Control and Prevention (CDC) Dr Baur has been extensively involved with health literacy initiatives at the CDC, including its Health Literacy Council, health literacy website and blog, and online health literacy training for health professionals.
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f r e e l a nc i ng
schedule at a glance Preliminary schedule as of June 2013
WEDNESDAY November 6
9:30 AM–12:30 PM
BELS Examination (Registration is through the Board of Editors in the Life Sciences, www.bels.org.)
Conference Registration and AMWA Information Desk Open 12:00–7:00 PM (County Foyer)
THURSDAY
November 7
12:00–4:00 PM
Exhibitor and Poster Setup
1:00–3:30 PM
2012-2013 AMWA Board of Directors Meeting (by invitation)
2:00–5:00 PM
Workshops
2:00–4:45 PM
Intensive Seminar (ticketed event, with additional fee)
4:00–5:30 PM
AMWA Chapter Delegates Meeting (by invitation)
4:30–5:30 PM
New to AMWA Orientation
5:45–6:30 PM
Conference Coach Connection
6:30–8:00 PM
Welcome Reception in the Exhibit Hall (cash bar), Posters on display (Regency Ballroom Foyer)
7:00 AM–7:00 PM Conference Registration and AMWA Information Desk Open (County Foyer) 7:30–8:45 AM
Roundtable Discussions with Breakfast (ticketed event)
9:00 AM–12:00 PM
Workshops and Open Sessions
10:30 AM–3:30 PM
Exhibit Hall open, Posters on display (Regency Ballroom Foyer)
12:15–1:30 PM
Networking Lunch in the Exhibit Hall (included with registration)
12:15–1:30 PM
AMWA Workshop Leader Lunch and Training (free ticketed event)
1:30–3:00 PM
Open Sessions
3:00–3:30 PM
Sponsored Beverage Break in the Exhibit Hall
Keynote Session with Alvarez Award Address: Gregory D. 3:30–5:00 PM Curfman, MD, Executive Editor, New England Journal of Medicine (Regency Ballroom) 5:00–6:00 PM
Networking Reception in the Exhibit Hall (cash bar)
6:15 PM
Chapter Greet & Go (Delaware Foyer)
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n e t wo r k i ng
schedule at a glance Preliminary schedule as of June 2013
FRIDAY
November 8
7:00 AM–4:00 PM Conference Registration and AMWA Information Desk Open (County Foyer) 7:30–11:00 AM
Exhibit Hall open, Posters on display (Regency Ballroom Foyer)
7:30–9:00 AM
Networking Breakfast with the Exhibitors and Passport Prize Awards (included with registration)
Visit with the Poster Presenters
9:00 AM–12:00 PM
Workshops and Open Sessions
11:00 AM–2:30 PM
Exhibit Hall and Poster Takedown
12:15–1:30 PM
Roundtable Discussions with Lunch (ticketed event)
2:00–5:00 PM
Workshops and Open Sessions
7:00–9:00 PM AMWA Sablack Awards Dinner (ticketed event, cash bar) (Regency Ballroom)
SATURDAY
November 9
7:00 AM–3:00 PM Conference Registration and AMWA Information Desk Open (County Foyer) 9:00–10:15 AM
General Session: McGovern Award Address, Cynthia Baur, PhD, Senior Advisor, Health Literacy, Centers for Disease Control and Prevention
10:30 AM–12:00 PM
Open Sessions
12:15–1:30 PM AMWA Annual Business Meeting Lunch and 2014 AMWA Annual Conference Kick-off Celebration (free ticketed event for AMWA members) (Regency Ballroom)
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2:00–5:00 PM
Workshops and Open Sessions
2:15–3:15 PM
2013-2014 AMWA Board of Directors Meeting (by invitation)
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technology
registration information ■
Registration opens: July 10, 2013
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Early registration rates: July 10 through August 28, 2013
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Regular registration rates: August 29 through October 16, 2013
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Last day to register before on-site registration: October 16, 2013
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On-site registration rates: November 6 through 9, 2013
AMWA Member*
AMWA Student Student Member Early or NonRegular On-site On-site Regular member $625 $650 $200 $250 $270
Nonmember
2013 AMWA Annual Conference Fees
Early
Full Conference Registration†
$450
$500
$550
$550
Wednesday, November 6
$50
$50
$75
$50
$50
$75
$20
$30
$50
Thursday, November 7
$150
$175
$200
$150
$175
$200
$50
$60
$100
Friday, November 8
$125
$150
$175
$125
$150
$175
$50
$60
$100
Saturday, November 9
$100
$100
$125
$100
$100
$125
$35
$45
$75
Regular On-site
Early
One-Day Registration
* If you are not an AMWA member, you can obtain the AMWA member fee by joining AMWA before registering. †
Ticketed events and workshops have additional fees.
Fee per ticket Early/Regular On-site $25 $30
Ticketed Events Breakfast Roundtable, Thursday, November 7 Lunch in the Exhibit Hall, Thursday, November 7
Free
Free
Lunch Roundtable, Friday, November 8
$25
$35
AMWA Sablack Awards Dinner, Friday, November 8
$60
$65
Business Meeting Lunch, Saturday, November 9
Free
$15
Guest Pass to Wednesday or Thursday Evening Reception
$35
$45
Intensive Seminar
$40
$45
AMWA Workshop Fees
AMWA Member
Nonmember
Member or nonmember
Early/Regular Early/Regular (basedOn-site on availability)
AMWA Credit Workshop
$110
$130
$150
AMWA Advanced Credit Workshop
$130
$150
n/a
AMWA Noncredit Workshop
$55
$75
$75
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ma r k e t i ng
registration information General Registration Information
Conference registration is an online process (register online at www.amwa.org). Payments accepted include VISA, MasterCard, American Express, and check. Please note that selecting the payment-by-check option does not guarantee seating in any workshop or activity. Registrations paid by check will not be processed until the individual check is received at AMWA headquarters and will be processed in the order in which they are received. The URL and password for downloading workshop homework from the web (if applicable) will be sent in electronic form.
Registration for Special/Ticketed Events
For events where reservations are required (eg, workshops, Intensive Seminar, Breakfast Roundtables), you must reserve your space during the registration process. Where attendance is limited, reservations will be made on a first-come, first-served basis. Tickets for events you have successfully reserved will be included in the registration packet you receive when you arrive at the AMWA Annual Conference. Please note that the Thursday and Saturday lunches are free with registration; however, advance registration is required so that we may plan accordingly.
Confirmation and Receipt
An automatic e-mail will be sent to confirm registration and provide a receipt. Registrations paid by check will not be processed until the check is received at AMWA headquarters and will be processed in the order in which they are received.
Key Deadline Dates
Early Bird rates are available through August 28. Regular registration rates: August 29 through October 16* On-site registration rates: November 6 through November 9
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Last day to cancel and receive a refund: October 16 Fees for credit workshops are nonrefundable on or after October 1, 2013. *If check payment is not received before you arrive at the conference, you will be charged the on-site registration fee. Your registration is not complete until payment has been received.
Cancellation/Refunds
The following are AMWA’s cancellation/refund policies. Conference registration: If you must cancel your conference registration, you must send a written note no later than October 16, 2013, to cancel registration and request a refund. Send e-mail cancellations and requests to annual_conference@amwa.org. Refunds will be issued through your method of payment, less a nontransferable $75 cancellation fee. Conference registration is nonrefundable after October 16, 2013. Ticketed event: If you must cancel a ticketed event, a $10 cancellation fee will be charged. Fees for ticketed events are nonrefundable after October 16, 2013. You must send a written note to cancel registration and request a refund. No refunds or credits will be given for failure to attend, late arrival, unattended events, or early departure. Credit workshop: If you must cancel or change your registration for a credit workshop, you need to send a written note to cancel registration. A $25 cancellation fee per workshop will be charged for cancellations made on or before August 28, 2013, and a fee of $50 will be charged for workshop cancellations made August 29 through September 30, 2013. Fees for credit workshops are nonrefundable on or after October 1, 2013. If AMWA must cancel a conference workshop for any reason, every effort will be made to notify registrants at least 14 days before the day of the workshop, and the workshop fee will be refunded in full. AMWA may not know of the need to cancel a workshop until a time closer than 14 days.
social media
registration information Substitutions
AMWA does not allow substitutes for conference registrations. Registration fees cannot be transferred to another person.
Registration Questions
If you have any questions or problems regarding your registration, please contact AMWA at annual_ conference@amwa.org or by telephone at 240-2380940, ext 103.
Participants with Disabilities or Special Needs
If you have a disability or special need that may affect your participation in the 2013 Annual Conference, please contact AMWA at annual_conference@amwa.org before October 15, 2013, to indicate your requirements.
AMWA Policies
Guests A guest at an AMWA meeting is defined as a spouse, partner, friend, adult child (21 years and older), or other family member. Guests are admitted to only evening receptions and the Sablack Awards Dinner. A medical communication colleague who will attend educational and professional programming may not register as a guest. He or she must pay the appropriate registration fee. Guest tickets may be purchased for the Wednesday evening reception, the Thursday evening reception, and the Sablack Awards Dinner on Friday. Guest tickets can be purchased online through the registration form or on-site at the conference.
Children If children accompany a parent to any AMWA event, arrangements should be made for their supervision. No one younger than 21 years old is permitted at events where alcohol is served. Children under the age of 18 are not permitted in AMWA meeting rooms, receptions, or the exhibit hall.
Consent to Use of Photographic Images Registration and attendance at, or participation in, AMWA’s Annual Conference and related events constitutes an agreement by the participant to AMWA’s use and distribution (both now and in the future) of the participant’s image or voice in photographs, videotapes, electronic reproductions, and audiotapes of the conference. Conference Content The contents of presentations and workshops are the work of the presenters and do not necessarily reflect the policies or positions of AMWA.
Registration and AMWA Information Desk Area On-site
Registration packets for people who have registered in advance will be available in the registration area beginning at 12:00 PM Wednesday, November 6, in the Hyatt Regency Columbus County Foyer on the second floor. The packet will contain the registrant’s identification badge with tickets (if applicable) and on-site program. On-site registration will also be available at the same location. AMWA staff will be on hand throughout the conference to answer your questions about membership services and benefits.
New Members and First Timers
If you are a new member or this is your first annual conference and you would like to connect with experienced AMWA members and other first-time attendees at the conference, plan to attend the New To AMWA Orientation on Wednesday from 4:30 to 5:30 PM and/ or the Conference Coach Connection on Wednesday evening from 5:45 to 6:30 PM, immediately before the Welcome Reception. These events are designed to provide an opportunity to meet and network with other attendees in a casual setting.
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m e n t o r i ng
Hotel and Location information AMWA’s 73rd Annual Conference will be taking place at the Hyatt Regency Columbus. AMWA is pleased to offer hotel sleeping room blocks at the Hyatt Regency Columbus, Crowne Plaza Columbus, and Drury Inn & Suites Columbus Convention Center. These comfortable and convenient accommodations are connected by a covered walkway so AMWA members can take full advantage of everything the AMWA conference has to offer. To make your hotel reservation online please visit the AMWA website www.amwa.org conference page for housing links or call the tollfree numbers listed below. Be sure to reference the AMWA Annual Conference to receive the discounted group rate. We expect the room blocks to fill up, so be sure to make your reservation early!
Hyatt Regency Columbus–AMWA Conference Hotel 350 North High Street, Columbus, OH 43215 Reservations: 1-888-421-1442 (Reference AMWA Annual Conference for discount) Rate: $158.00 per night (single/double occupancy) Tax: 16.75% per night Hotel cut-off date for group rate: October 14, 2013 Crowne Plaza Columbus–Downtown 33 East Nationwide Blvd, Columbus, Ohio 43215 Reservations: 1-614-461-2642 (Reference AMWA Annual Conference for discount) Rate: $158.00 per night (single/double occupancy) Tax: 16.75% per night Hotel cut-off date for group rate: October 4, 2013 Drury Inn & Suites Columbus Convention Center 88 East Nationwide Blvd, Columbus, OH 43215 Reservations: 1-800-325-0720 (Reference group number 2028962 AMWA Annual Conference for discount) Rate: $151.00 per night (single/double occupancy; rate includes complimentary hot breakfast and wireless Internet in sleeping room) Tax: 16.75% per night Hotel cut-off date for group rate: October 1, 2013, but discounted room block may fill before then All reservations made after the blocks are filled and/or after the deadline will be available at the hotel’s prevailing rate and availability is not guaranteed.
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Why stay at the conference hotels? Our conference headquarters hotel is the center of conference activity. Staying at the hotels in the AMWA hotel block enables you to network easily with other conference attendees and quickly get to the program and functions, and back to your room for a break. Your support in staying at one of the AMWA contracted hotels listed above also helps keep the conference costs down, which directly affects your registration fees. AMWA contracts for the best possible room rates each year and is required to guarantee a predetermined number of sleeping rooms. If the association does not fill the contracted room block, the hotel can charge an attrition fee, which will result in higher registration fees at future conferences. Individuals who choose to stay outside of the block receive the benefit of the conference facilities, but do not contribute to the necessary commitments that allow AMWA to block appropriate function space for our meeting. Therefore, we encourage you to book your room through our blocks at one of the hotel listed above and identify yourself as an AMWA conference attendee.
slide design
travel information Named for Italian explorer Christopher Columbus, the capital city of Columbus, OH, is home to one of the nation’s largest universities, a world-class zoo featuring more than 650 wildlife species, excellent museums, and a number of other attractions. Several popular neighborhoods near downtown offer some of the best dining, shopping, and entertainment options in the city. Columbus is the largest city in Ohio and is located within 550 miles of more than half of the nation’s population. The city has become a culinary destination over the past few years, and the North Market in the Short North neighborhood is considered the city’s food hub. Open year-round, the airy converted warehouse hosts 35 vendors, including butchers, bakers, and ice cream makers. The Hyatt Regency Columbus is located in the heart of the Arena District where you can have a beer or a meal at one of the Arena District’s many dining and bar options, including the ever-popular Gordon Biersch and 343 Front Street. Also within walking distance is the eclectic Short North Arts District, featuring numerous art galleries, shops, and Columbus attractions.
Hyatt Regency Columbus
Port Columbus International Airport (CMH) is only a 10-minute drive from downtown Columbus. Major airlines offer more than 30 nonstop destinations, with a total of 140 nonstop flights per day. Carriers include Air Canada, AirTran, American, Delta, Southwest, United, and US Airways. For further information and to research lowest fares visit www.flycolumbus.com.
From left: Short North district arches, COSI Center of Science and Industry, Franklin Park Conservatory, and German Village historic neighborhood. Photos courtesy of www.touring-ohio.com.
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e d u cat i o n
full program schedule | key key TO SCHEDULE Abbreviations IS OS WS NC T F
Intensive seminar Open session (includes Topic Seminars, Panel Presentations, Encore Presentations, Pro/Con Debates, and Hands-on Demonstrations) Workshop Noncredit workshop Thursday Roundtable Discussions with breakfast Friday Roundtable Discussions with lunch Golden Apple Award Recipient for excellence in teaching in the AMWA education program
Intensive Seminar and Open Session Designations The word in brackets after the title of Intensive Seminars and open sessions indicates the track (topic area) of the session. The schedule has been designed to optimize the number of sessions within a track that an attendee can participate in. Workshop Designations The titles of credit workshops are followed by designations (in parentheses) and permanent workshop number (in brackets). Workshop designations indicate the certificate program(s) to which the workshop is applicable. Most workshops are listed with multiple designations to accommodate both the new and old certificate programs. Credit workshops are designated as follows. ES
Essential Skills
For people enrolled in the Essential Skills certificate program
B CP RR SM
Business Composition and Publication Regulatory and Research Concepts in Science and Medicine
For people enrolled in one of the Specialty certificate programs
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General G ED Educators EW Editing/Writing FL Freelance PH Pharmaceutical PRAM Public Relations/Advertising/Marketing For people who enrolled in the Core certificate program before January 31, 2010, and are working to complete a Core certificate in one of the program areas
SG SBS SDS SDT
Science—General Science—Body Systems Science—Disease States Science—Diagnostics and Therapeutics
For people who enrolled in the Science Fundamentals certificate program before January 31, 2010, and are working to complete that certificate
ADV
Advanced
For people who enrolled in the Advanced certificate program before January 31, 2010, and are working to complete that certificate
More information about AMWA’s certificate program is available starting on page 66. NOTE: Certificate program enrollees should check their individual AMWA records to determine whether they have already taken specific workshops.
journal management
full program schedule | wednesday All events take place at the Hyatt Regency Columbus.
Wednesday, November 6 9:30 AM–12:30 PM
BELS EXAMINATION (Registration is available through the Board of Editors in the Life Sciences, www.bels.org.)
12:00–7:00 PM
CONFERENCE REGISTRATION AND AMWA INFORMATION DESK OPEN
2:00–5:00 PM WS-1 | Tables and Graphs (ES/G) [2011]
The workshop leader will cover definitions and uses of tables and graphs, as well as guidelines for preparing and editing them. The focus of the workshop, designed for the beginner, is the preparation of tables and graphs that are usable, that communicate, and that are appropriate for the situation. Participation is encouraged as we evaluate problematic tables and graphs. APPROXIMATE HOMEWORK TIME: 3−4 HOURS. Same as WS-49.
12:00–4:00 PM
EXHIBITOR AND POSTER SETUP
Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach, VA
1:00–3:30 PM
WS-2 | Effective Paragraphing (ES/G) [2003]
2012-2013 BOARD OF DIRECTORS MEETING (by invitation) Presiding: Douglas Haneline, PhD, 2012-2013 AMWA President
2:00–4:45 PM
Ticketed event, with additional fee IS-1 | Intensive Seminar: Create Visibility and Influence to Fast Track Your Career [Career Development] Do you feel you have no control over your career? Are your salary increases pretty standard, no matter how well you do your job? If your department reorganized tomorrow, would you be at risk? Do you want to feel confident that even if your employer were silly enough to let you go, you had the strategies and skills to land an even better job? Learn ways to take charge of your career and unlock your potential, discover secrets to make sure your boss (and others) recognize the incredible value you offer, and learn how to have influential conversations that get you new opportunities. Limited to 60 participants. John West Hadley, Career Search Counselor, John Hadley Associates, LLC, www.JHACareers.com, Somerville, NJ
This lecture and discussion workshop provides novices and moderately experienced writers and editors with some basic paragraphing techniques for achieving clarity, readability, and desired emphasis. The objective is development of a systematic approach to analyzing and correcting text. Options for arranging paragraphs and using transitions will be demonstrated in this review course. APPROXIMATE HOMEWORK TIME: 4 HOURS. Same as WS-47.
Flo Witte, PhD, ELS, Bluegrass Editorial Services Team, Winchester, KY
WS-3 | Business Ethics for Medical Communicators (B) [2511] This workshop is required for individuals working to earn the Business specialty certificate. The workshop provides an overview of ethical considerations involving the business aspects of medical communication in different work settings, including both large and small organizations as well as sole proprietorships. The workshop comprises a homework assignment, an interactive lecture, and a class exercise. Participants will be divided into small groups, each of which will
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full program schedule | wednesday be given one of the case studies submitted as part of the homework. Groups will be asked to name the ethical situation, identify the stakeholders and their perspectives, debate potential decisions, and present their results to the entire group through role-play. APPROXIMATE HOMEWORK TIME: 2–3 HOURS. Andrea R. Gwosdow, PhD, President, Gwosdow Associates Science Consultants, LLC, Arlington, MA
WS-4 | Proofreading: Strategy for Document Quality
Control (CP/EW) [3013] Proofreading is the final—and often underappreciated—step in producing professional documents. This introductory or refresher workshop focuses on proofreading as a strategy for document quality, distinct from writing or copyediting. More than catching typos, proofreading strategies include achieving consistency, sharpening attention to mechanical errors, and identifying and correcting production and layout issues. Standard proofreading practices and electronic proofreading methods will be discussed. Participants will learn to train both the mind and the eye to determine what to correct, query, or ignore. APPROXIMATE HOMEWORK TIME: 2–3 HOURS. Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Marfa, TX and Nashville, TN
WS-5 | Principles of Epidemiologic Research:
Beyond the Basics (SM/SG) [3521] The workshop leader will cover the basic principles of chronic-disease epidemiology, including measures of disease frequency, common study designs, and issues of validity and precision. Attendees will learn the key features that distinguish observational research from experimental designs, as well as the basics of interpreting epidemiologic research within the context of medical communication. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
John A. Bukowski, DVM, MPH, PhD, WordsWorld Consulting, Dayton, OH
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WS-6 | Writing the Final Report of a Clinical Trial
(RR/PH) [4016] This workshop is intended for novices and moderately experienced medical writers; the leaders will offer approaches to generating a clinical study report. The components of the report, issues of quality control, and common problems and situations will be reviewed. Within this framework, ideal and real-world experiences will be discussed. The impact of guidelines from the International Conference on Harmonisation (ICH) and their effect on the standard report structure will be discussed in detail. APPROXIMATE HOMEWORK TIME: 4 HOURS. Same as WS-62.
Howard M. Smith, MA, Consultant Medical Editor, Sandy Hook, VA
4:00–5:30 PM
CHAPTER DELEGATES MEETING (by invitation) Presiding: Katharyn Spiegel, PhD, 2012-2013 Administrator, Department of Chapter Relations Members who have been appointed by their chapters as delegates to the Board of Directors are invited to attend. This session provides delegates an opportunity to discuss chapter issues that may have arisen since the spring board meeting.
4:30–5:30 PM
NEW TO AMWA ORIENTATION This session provides an opportunity for those who are new to AMWA to ask questions about how AMWA works and to learn more about the benefits of belonging to an association of medical communicators.
5:45–6:30 PM
CONFERENCE COACH CONNECTION If this is your first AMWA Annual Conference and you would like to connect with experienced AMWA members and other first-time attendees at the conference, plan to attend the Conference Coach Connection on Wednesday evening immediately before the Welcome
collaboration
full program schedule | thursday Reception. It is designed to provide an opportunity to meet other attendees in a casual setting and to obtain answers to your questions about AMWA and the Annual Conference.
6:30–8:00 PM
WELCOME NETWORKING RECEPTION IN THE EXHIBIT HALL Join your colleagues in a fun and informal setting with hors d’oeuvres and a cash bar. It’s also your first chance to visit with exhibitors and browse the posters. (See page 33 for the list of accepted posters.)
Thursday, November 7 7:00 AM–7:00 PM
CONFERENCE REGISTRATION AND AMWA INFORMATION DESK OPEN
7:30–8:45 AM
ROUNDTABLE DISCUSSIONS WITH BREAKFAST (ticketed event, with additional fee) Roundtable discussions are led by a facilitator who has experience with the topic. The discussions are interactive, not didactic, and participants at each table are encouraged to share their experience and knowledge on the topic. Attendance is limited to nine participants at each table.
T-1 | 401k Plans for Freelances
You may know about the SEP-IRA and SIMPLE, but do you know about the individual 401k plan (i401k)? Learn about the pros and cons of these three retirement savings plans, review concrete examples that demonstrate how different financial situations affect contribution limits, receive a list of brokerage firms that provide i401ks, and come away with questions to take home to your investment and tax advisors.
T-2 | All I Ever Wanted to Know About Beginning a
Regulatory Writing Career I Learned at AMWA Participants will learn more about what regulatory writing is and what it is not, with a discussion of the types of regulatory deliverables, regulatory agencies, valuable skills for regulatory writing, project management, customer service skills, and useful resources to get started in this field.
Eileen M. Girten, MA, inVentiv Health Clinical, Blue Bell, PA
T-3 | AMWA Certification Commission: How to Get
Involved and Answers to Other Questions Learn how to become involved with the next phases of developing a certification process. Bring your questions!
Karen Potvin Klein, MA, ELS, Certification Commission
T-4 | The Benefits of Publication SOPs
Participants will discuss experiences in developing and abiding by standard operating procedures (SOPs), the pros and cons of having SOPs, how publication SOPs can address challenges faced by industry professionals, and how government-issued Corporate Integrity Agreements affect the publication process. This roundtable discussion is repeated on Friday.
Jenilyn J. Virrey, PhD, Amgen Inc., Thousand Oaks, CA
T-5 | CER: What Do These Three Letters Mean?
Participants will learn the general definitions of CER by the various organizations involved, discuss how to identify the different approaches that the main involved organizations take to CER, and explore some of the possibilities for joining the CER efforts.
Danny A. Benau, PhD, Biomedical Writing Programs, University of the Sciences, Philadelphia, PA
Jeanne McAdara-Berkowitz, PhD, Biolexica Health Science Communications, Longmont, CO
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health communication
full program schedule | thursday T-6 | Desperately Seeking Standards: Tracking
Changes in PowerPoint Participants will share their experiences tracking changes in PowerPoint and discuss ways to meet client expectations and editorial challenges. This is not a tutorial in PowerPoint per se, but a facilitated discussion for people who regularly edit slide decks and have been frustrated with the limitations of the technology. By starting this conversation, we can learn how others in the field are using PowerPoint and begin to identify common—and best—practices. This roundtable discussion is repeated on Friday.
Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Marfa, TX, and Nashville, TN
T-7 | Document Review and Revision: What Works?
Participants will discuss the problems and pitfalls medical writers face during the document revision life cycle and share tools and strategies for successful document approval and release. Topics will include common areas with “room for improvement,” versioning, and templates.
Darryl Z. L’Heureux, MS, PhD, CSL Behring, King of Prussia, PA
T-8 | Double-Annotating Deliverables for MRL Review
This roundtable session will foster a discussion of the processes of annotating medical/scientific deliverables and preparing digital reference binders for clients in the pharmaceutical, health care, and biotechnology industries. These processes are the groundwork toward efficient review and approval by clients’ respective medical-regulatory-legal (MRL) review committees.
Brandy L. Weidow, MS, ELS, Meredith Xcelerated Marketing Health (MXM Health), Seattle, WA
T-9 | Electronic Archiving for the Home Office
Participants will learn to distinguish between “backing up” and archiving, be able to organize files and e-mails
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so that they can be quickly found and accessed, name software solutions for cataloging files and archiving e-mails, describe hardware options, explain the limitations of electronic media, and provide examples of when it is appropriate to use electronic media. This roundtable discussion is repeated on Friday. Kathy Spiegel, PhD, Amgen Inc., Grass Lake, MI
T-10 | Electronic Regulatory Submission Capability
for Freelance and Consultants: Opportunities and Challenges Participants will discuss common challenges and potential solutions for obtaining and maintaining e-submission skills, accessing needed technical/software solutions, and communicating and collaborating with clients.
E.M. (Mitch) Seymour, PhD, RAC, SciMedLit, LLC, Ypsilanti, MI
T-11 | Fostering Successful Partnerships Between
Editors and Authors at Academic Medical Centers Participants will explore ways to develop positive and effective working relationships with the authors whose work they edit. Topics will include starting off on the right foot with new authors, when to seek help from authors to understand their research, and how to avoid becoming overwhelmed.
Erica Goodoff, ELS, The University of Texas MD Anderson Cancer Center, Houston, TX
T-12 | Freelance Writing for the Medical Device
Industry Participants will discuss segueing into writing about medical devices, including regulatory-jurisdictional distinctions between regulatory bodies; talk about differences between writing for medical devices and drugs/biologics; and share strategies for obtaining job leads. This roundtable discussion is repeated on Friday.
Jim Hudson, Medical Writing Associates, Simi Valley, CA
P U B LI C ATION P L A NNING
full program schedule | thursday T-13 | Launching a Freelance Medical Writing
Business This discussion will focus on how to identify essential resources for starting and/or maintaining a freelance medical writing business, evaluate networking strategies, appraise professional development opportunities, and formulate business goals.
Amy Rovi, Medivor, LLC, Collegeville, PA
T-14 | Making the Most of a Tough Situation: My
Story on Integrating a Global Partner Participants will discuss the hurdles and triumphs of working with medical writers and editors outside the United States.
David M. Clingan, inVentiv Health Clinical, San Antonio, TX
T-15 | Making Sense of Science: Tips for Presenting
Scientific Concepts to Audiences with Nonscience Backgrounds Participants will discuss the challenges in communicating science to nonscientists and share tips on how to enhance the effectiveness of their presentation, to simplify scientific concepts without compromising scientific accuracy, and to craft a presentation to suit a specified target audience.
Anand Devasthanam, Roswell Park Cancer Institute, Buffalo, NY
ways to use editing to improve efficiency while preserving author/editor relationships. Tracey Fine, MS, ELS, Fine Biomedical Communications, Inc., Chapel Hill, NC
T-18 | Medical Journalism Do’s and Don’ts: Tips for Successful Reporting and Writing This roundtable focuses on tips to help participants write magazine and other types of articles on medical topics for the public. Topics include the process of gathering and evaluating information for the articles, writing the articles, and addressing ethical and other issues that the writer may encounter. This roundtable discussion is repeated on Friday.
Barbara Gastel, MD, MPH, Texas A&M University, College Station, TX
T-19 | Mining the Internet: Online Resources for
Medical Communicators Participants will discuss where to find up-to-date demographic data, basic disease state information, clinical practice guidelines, health surveillance data, and more on the Internet. The focus will be on resources that are acceptable for medical-regulatorylegal (MRL) review, websites to avoid, and tools that can enhance productivity and time management. This roundtable discussion is repeated on Friday.
Cynthia L. Kryder, MS, CCC-Sp, Phoenixville, PA
T-16 | Managing Medical Writers Remotely
At this roundtable, participants will discuss the challenges frequently encountered by medical writers who work remotely and ways to successfully integrate, manage, and develop such workers.
Caryl L. Burke, MA, Medpace, Inc, Cincinnati, OH
T-17 | Medical Editing: From Copy Editing to
Developmental Editing This roundtable discussion will focus on scientific editing, understanding the levels of scientific editing, and
T-20 | Oral Questioning Skills for Medical
Communicators A major factor in a medical communicator’s professional success is asking questions—the right questions. At this roundtable, participants will discuss and practice ways to hone their questioning skills in order to elicit the right information they need to do their job. This roundtable discussion is repeated on Friday.
Elizabeth G. Frick, PhD, ELS, The Text Doctor LLC, Boulder, CO
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full program schedule | thursday T-21 | Publishing a Physician-Targeted Newsletter
Participants will discuss all aspects of publishing a physician-targeted newsletter. Topics include identifying the target audience; setting a budget; assembling an editorial team; designing the publication; setting production and publication schedules; deciding on content and assigning stories; editing, reviewing, and approving content; determining distribution methods; and soliciting feedback.
Leslie Neistadt, ELS, Saint Louis University, St Louis, MO
T-26 | Successfully Targeting Medical Communi-
Jude Richard, ELS, Synchrogenix Information Strategies Inc., Austin, TX
T-22 | Responding to Audit Recommendations and
Bradley Philbrick, RPH, Community Westview Hospital, Indianapolis, IN
Thomas J. Purcell, MS, Urtech Medical Writing & Consultancy LLC, Saline, MI
T-23 | Scientific Congress Coverage for a
Pharmaceutical/Biotechnology Company Participants will discuss and learn how to obtain and report essential information from a flagship clinical congress and discuss insights for gathering information efficiently. This roundtable discussion is repeated on Friday.
Albert Y. Rhee, PhD; Amgen Inc., Thousand Oaks, CA
T-24 | So, You Want to Do a Webinar. . . Here’s How
and Why Webinars are a valuable marketing tool for any business. If you have ever (or never) considered doing your own webinar, then you need this roundtable. Learn about the benefits of webinars for your business, how to develop and market your webinar, and pitfalls to avoid.
Debra Gordon, MS, GordonSquared, Inc., Williamsburg, VA
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Participants will discuss topics covered on the Board of Editors in the Life Sciences (BELS) exam, the exam format, and recommended ways to prepare for the exam.
cation for both Clinicians and Administrators Participants will discuss health care professional roles, their medical information needs, and ideas about how to better provide this information.
Observations Without Confrontation or Frustration Participants will learn about the origins and intent of the audit and the role of both auditor and auditee, discuss how to effectively address errors in interpretation of audit findings, and explore employee strategies to reduce potential confrontations/bias in audit responses.
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T-25 | So, You’re Going to Take the BELS Exam...
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T-27 | Using Checklists for More Efficient Editing
This discussion will focus on industries that require the use of checklists and items that could appear on editing checklists. Participants will learn how to formulate their own checklists in order to avoid common errors and speed the editing process. This roundtable discussion is repeated on Friday.
Kelly A. Schrank, Med Communications, Canastota, NY
T-28 | Best Practices for Writing Quality Summaries
and Other Regulatory Documents When Timelines are Tight Participants will learn how to create succinct timelines and how to work within those timelines to create the highest quality deliverable(s) through use of shell reports and skeleton tabular presentations that can serve as templates for similar documents within a single submission and that serve to ensure consistency across similar documents. Also discussed will be two document review systems, quality control and quality assurance, with emphasis on the distinct role and value of these processes in delivering documents that are high in quality and on target. Please note that the day and time of this roundtable discussion has been changed since the original posting of the brochure.
Michael L. Jones, MS, TKL Research, Inc., Rochelle Park, NJ
regulatory writing
full program schedule | thursday T-29 | Writing Science for Children and Young Adults Participants will learn about childhood development and explore the suitability of topics for each age group. The discussion will also focus on some practical aspects of writing, marketing, and selling to such markets as books, magazines, and other media.
Evelyn B. Kelly, PhD, Kelly Communications, Ocala, FL
T-30 | Your Website Is Your Professional Image
Participants will explore the advantages of creating a website as a marketing tool, a reflection of their professional image, an online portfolio, a repository of client recommendations, and more. Topics include purchasing and registering a domain name, choosing a web hosting service and content management system, building a website structure, finding images, and writing in “web-speak.” This roundtable discussion is repeated on Friday.
Jennifer G. Maybin, MA, ELS, Maybin Healthcare Communications, LLC, Branchburg, NJ
7:30–8:45 AM
Chapter Resource Room Open Meet to discuss chapter issues with your chapter members or with other chapter leaders. You must reserve space at annual_conference@amwa.org to ensure that the room can accommodate your meeting.
9:00–10:00 AM OS-1 | Health Care Reform 2.0: What It Means for
Medical Writers [Health and Medicine] What if… You woke up one morning and everyone around you was speaking a new language? The “rules of the road” changed and you now had to drive on the left side, not the right? The players on your favorite sports team switched with those on the other team in the middle of the championship game? What if all three of these things happened at once?
Would you be confused? Disoriented? Frantic? Well, that’s exactly what’s happening in health care. Not only is there a new language to learn, but the rules are changing and the players are shifting. No matter what type of medical writing you do—regulatory, marketing/ promotional, training, continuing medical education, patient-oriented—you need to learn how to speak “health reform,” follow the new rules, and identify the new players. Debra Gordon, MS, President, GordonSquared, Inc., Williamsburg, VA
OS-2 | Structured Writing: Today’s Best Practice for
Medical Content [Writing/Editing] Aggressive timelines, rapidly expanding product lines, increasing claims tracking, multiple regional regulatory requirements, translation, and requirements for print, web, and mobile content are putting pressure on writers to find better ways of creating and managing content. Structured writing best practices define and ensure that structure remains consistent, variations are defined, and content requirements are agreed upon. Structured content also speeds up the review process. With structured content, writers can focus on what they do best: writing effective, clear, and compliant content that can be adapted to multichannel requirements. See examples of how structured writing best practices can apply to submissions, labeling, and marketing content and receive a roadmap for a phased approach to structured writing.
Ann Rockley, MIS, CEO, The Rockley Group Inc., Schomberg, ON
9:00–10:30 AM OS-3 | Focus on FDA: Website, Guidance Practices, and Drug Information Databases [Regulatory] This seminar will provide a guide to drug information resources and databases available on the US Food and Drug Administration (FDA) website. FDA’s good
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full program schedule | thursday guidance principles are included in this discussion and should be of special interest to regulatory medical writers and editors. You will learn how to navigate the website to find useful, relevant, and current drug information in a variety of media formats, and will become familiar with the actual framework for developing the guidances used by the Agency. Lesley R. Navin RN, MSN, Consumer Safety Officer, Division of Drug Information, Center for Drug Evaluation and Research, Silver Spring, MD Michelle Eby, PharmD, CCRP, Consumer Safety Officer, Division of Executive Operations, Center for Drug Evaluation and Research, Silver Spring, MD
OS-4 | Putting Plain Language into Practice: Training, Tools, and Trends [Writing/Editing] Plain language has benefits for every audience. It helps patients with lower literacy skills or limited secondlanguage fluency to understand their diagnosis and treatment. It helps busy practitioners to quickly grasp complex information. It helps members of the general public to learn more about their own health and preventive strategies. And it delights wordsmiths with the elegance of good information conveyed clearly and simply. This session will provide a refresher on plain language, with an emphasis on a new training program for plain language practitioners, the use of plain language in patient education materials destined for translation, and the application of plain language in creating online resources.
Moderator: Peggy Robinson, ELS, Freelance Medical Editor, Ottawa, ON Deborah S. Bosley, Principal, The Plain Language Group, Professor Emerita, University of North Carolina at Charlotte, Charlotte NC; President of PLAIN (The Plain Language Association International) Diane Moyer, MS, RN, Associate Director, Health System Patient Education, The Ohio State University Wexner Medical Center, Columbus OH
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Janice (Ginny) Redish, PhD, Redish & Associates, Inc., Bethesda MD
OS-5 | The Rising Tide of Plagiarism in Medical
Writing [Journal Management] Medical journals have been broadsided by a fast-growing plagiarism problem, and the ramifications can reach well beyond the page, having an impact on clinical practice and patients’ lives. You will have an opportunity to examine the ripple effects of medical plagiarism and gain insight into avoiding the ethical and career-threatening pitfalls of duplication. In this panel presentation, you will hear about plagiarism from the editor’s perspective and learn about plagiarism detection software and how to evaluate the results and share the information ethically with contributing authors and/or their sponsors.
Moderator (and speaker): Jonathan Bailey, Founder, Plagiarism Today, New Orleans, LA Jason Chu, Senior Education Manager, iThenticate/Turnitin (iParadigms, LLC), Oakland, CA Sandra Ripley Distelhorst, ELS, Senior Editor, Northwest Health Communications, Edmonds, WA
9:00–11:45 AM
Ticketed event, with additional fee IS-2 | Intensive Seminar: The P.A.T.H. from Writer to Consultant [Freelance] Do clients view you as “just a writer” or a “just a proofreader”? Learn the P.A.T.H. to positioning yourself as a valued, expert consultant leads to stronger, more successful, and more lucrative client relationships. Learn how to engage with your clients so that your expertise is valued and your partnership is strengthened. From negotiating timelines, to gaining commitment, to effectively pushing back, you will learn proven client management techniques that you can start to use immediately. Limited to 60 participants. Jason Berkowitz, Vice President, Client Services, Pontoon, Longmont, CO
e d i t i ng
full program schedule | thursday 9:00 AM–12:00 PM WS-7 | The Synergy of Style, Substance, and
Audience (ADV) [711] This workshop is for experienced wordsmiths who wish to participate in a group discussion about what constitutes style in science writing. As participants consider elements of style in various sample manuscripts, they will also determine how to modify style to make material more effective for different target audiences. Throughout the workshop, the combined effects of substance and style will be covered in discussion and problem-solving units. Recommendation: Effective Paragraphing workshop and Organizing the Biomedical Paper workshop or at least 5 years’ experience as the primary author or substantive editor of biomedical manuscripts. APPROXIMATE HOMEWORK TIME: 6 HOURS. Elliott Churchill, MS, MA, President, A World of Words, Atlanta, GA
WS-8 | Critical Appraisal for Writers and Editors of
Biomedical Research Articles (ADV) [726] This workshop is intended for advanced biomedical writers and editors who want to improve their skills in critically appraising biomedical research or to improve their ability to think critically. The presentation and discussions will evolve around 13 questions and related concerns about the justification, design, execution, analysis, and interpretation of biomedical research studies. The precourse assignment consists of reading several abstracts and then asking questions raised by presence or absence of the information in the abstract. APPROXIMATE HOMEWORK TIME: 3–4 HOURS.
MaryAnn Foote, PhD, MA Foote Associates, Westlake Village, CA
WS-9
| Effectively Searching Online Databases (ES/EW/ FL) [2004]
This workshop includes live Internet demonstration and is intended for those with moderate to more advanced
web experience. The workshop leader will focus on the use of online databases, demonstrating the effective use of PubMed and several databases from the National Library of Medicine and other sources. Topics include use of advanced functions and features of databases rather than simply entering terms, as typically done on most search engines. For example, PubMed’s MeSH database, search builder, topic-specific queries will be demonstrated, as will the LinkOut connections to other databases or full-text resources when available. Creating and using personalized settings and search filters for these resources will also be covered. Interactive discussion and instruction-by-example will give participants an improved understanding of online search strategies and a helpful list of web-based information resources. If you usually search PubMed by typing in a few simple terms into the search box, then this class is for you. Attendees with independent Internet access (ie, not dependent on hotel or conference facilities) are welcome to bring their laptops or mobile devices to follow along. APPROXIMATE HOMEWORK TIME: 2 HOURS. Thomas Gegeny, MS, ELS, Envision Scientific Solutions, Southport, CT
WS-10 | Statistics for Medical Writers and Editors
(ES/G/SG) [2010] This workshop is designed for participants who have little or no background in statistics. Elementary statistical concepts needed to understand medical and scientific articles will be covered, including types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and Student’s t test. Emphasis will be placed on understanding statistical presentations and on reporting statistical information, not on calculations or mathematical explanations. APPROXIMATE HOMEWORK TIME: 3 HOURS. Same as WS-30. Bart Harvey, MD, PhD, University of Toronto, Toronto, ON
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full program schedule | thursday WS-11 | Outlining for Writers and Editors (ES/EW/FL)
[2007] This workshop is designed for intermediate-level writers and editors. Participants will learn to use outlining for writing and editing medical texts. Topics will include the “what, why, and how” of formal outlining and its usefulness in gaining consensus on planned content, overcoming mental blocks, and reorganizing drafts. APPROXIMATE HOMEWORK TIME: 2–3 HOURS. Same as WS-48.
Sue Hudson, Senior Medical Writer, Medical Writing Associates, Simi Valley, CA Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Marfa, TX and Nashville, TN
WS-12 | Basic Grammar I (ES/G) [2000]
Thorough knowledge of parts of speech is truly basic to good writing and editing. This workshop focuses entirely on parts of speech and their use in the sentence. Types of nouns and pronouns, verb tense, pronouns and case, phrases and clauses (with special emphasis on verbals and on noun, adjective, and adverb clauses), and the types of sentences are some of the primary topics that the workshop covers. Information in this workshop is, in essence, basic to every other AMWA workshop. APPROXIMATE HOMEWORK TIME: 2 HOURS. Same as WS-31.
Jude Richard, ELS, Synchrogenix Information Strategies Inc., Austin, TX Chrissie Worth, MA, ELS, Communications Advisor, South Calgary Primary Care Network, Calgary, AB
WS-13 | Fundamentals of Freelance Business
Marketing (B) [2510] Launching and building a successful freelance business takes marketing muscle. This workshop will help those who are new to freelancing or who are thinking about
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launching a freelance business strengthen that muscle, so they can get their freelance business off the ground and into the fast lane. The workshop leader will cover the whos, whats, wheres, whys, and hows of marketing a freelance business, and the exercises participants will do as homework and during the workshop will get them pumped up and ready to take on the challenge. APPROXIMATE HOMEWORK TIME: 4 HOURS. Brian Bass, President, Bass Global, Inc., Robbinsville, NJ
WS-14 | Writing Abstracts (CP/EW/PH) [3019]
This workshop is intended for medical editors and writers with up to 5 years’ experience. An overview of the purpose and structure of the medical or scientific abstract will be given, with emphasis on abstracts prepared for publications. Registrants will evaluate and write abstracts based on precourse materials and workshop exercises. APPROXIMATE HOMEWORK TIME: 1–2 HOURS.
Thomas Annesley, PhD, Professor, University of Michigan; Deputy Editor, Clinical Chemistry, Ann Arbor, MI
WS-15 | Developing Publications in Accordance with
GPP2 Guidelines (CP) [3026] This workshop is intended for novices and moderately experienced writers and editors. The leader will describe a collaborative and transparent process for developing company-sponsored publications based on the Good Publication Practice for Communicating Company Sponsored Medical Research: GPP2 Guidelines. Through a combination of lecture and group discussion, participants will learn how to develop a publication from initiation through to submission and how to deal with a number of controversial issues, including authorship, access to data, and conflicts of interest. APPROXIMATE HOMEWORK TIME: 3 HOURS. Kathryn Boorer, PhD, Medical Writing Senior Manager, Amgen Inc., Thousand Oaks, CA
M EDI C A L DEVI C ES
full program schedule | thursday WS-16 | Making Effective Slides (CP/EW) [3008]
This workshop is designed for beginners and those with some slide-making experience. Participants will work through the ground rules for writing and designing medical slides, critique examples of good and bad slides, touch on production concerns, and evaluate slides made from the homework. The workshop leader will not include instructions on using PowerPoint software. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Lawrence Giraudi, MSc, Manager, Regulatory Documentation, Hoffmann-La Roche, Toronto, ON
WS-17 | Creating Effective Poster Presentations (CP/ EW/PH) [3001] This interactive workshop is designed for beginning to intermediate poster creators, and the leader will cover everything from planning to production. Participants will learn about creating a poster from an abstract, developing structured versus unstructured content, selecting effective graphic presentation methods, and dealing with production issues. Attendees will evaluate sample posters and suggest improvements for layout and content. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach, VA
WS-18 | Usage: Choosing the Right Word for the Job
(CP) [3027] Designed for moderately experienced medical communicators, this workshop focuses largely on words that are commonly misused in medical writing. We will discuss what is considered correct usage in the academic medical literature (mainly according to AMA style), as well as how to choose words for maximum precision and conciseness. The workshop format includes lecture and group exercises, and time for participants to raise
questions about usage. APPROXIMATE HOMEWORK TIME 0.5−1 HOUR. Stephen N. Palmer, PhD, ELS; Senior Scientific Medical Writer, Texas Heart Institute, Houston, TX
WS-19 | Evidence-Based Medicine for Medical
Communicators (SM) [3509] This introduction to evidence-based medicine (EBM) is intended for medical communicators at any level who have an interest in EBM as it applies to critical appraisal of the medical literature, production of higher-quality medical documents, or job opportunities involving EBM. The workshop will be taught through an informal lecture format with a group-learning activity and time for discussion. Topics will include what EBM is, the context in which it developed, how it is practiced, tools of EBM, study design, levels of evidence, bias, and the standards movement. Statistics associated with EBM will not be covered in depth. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Tami Ball, MD, inVentiv Health Clinical, Asheville, NC
WS-20 | Basics of Molecular Biology (SM/EW/PH/SG) [3504] Aimed at beginning and moderately experienced science editors and writers, the lecture and discussion of this workshop will help participants understand basic molecular biology concepts about DNA, RNA, and protein structure. Key terms and commonly used techniques will be reviewed, as will useful writers’ resources. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Dominic De Bellis, PhD, Senior Associate Director, Medical Writing, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT Hilary Graham, MA, Program Manager, Communications, MD Anderson Cancer Center, Houston, TX
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full program schedule | thursday WS-21 | Introduction to the Endocrine System (SM)
WS-23 | Regulatory Aspects of the Drug
Joanne M. McAndrews, PhD, Freelance, St. Louis, MO
Aaron Bernstein, PhD, Director, Medical Writing, Warner Chilcott, Rockaway, NJ
[3513] Endocrinology is the study of hormones and the glands that produce them. This workshop is intended for medical writers and editors with little or no background in endocrinology. Participants will learn the basic anatomy and physiology of the various endocrine glands in the human body (eg, the hypothalamus, pituitary, adrenal glands, reproductive organs) and the different types of hormones that these glands produce. The workshop leaders will also discuss the wide-ranging effects of hormones on different body systems, their mechanism of action, and methods for measuring hormone levels. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Jacqueline F. Wu, PhD, Owner and Medical Writer, Castle Peak Medical Writing, San Jose, CA
WS-22 | Summarizing Clinical Safety Data for an NDA (RR) [4014] This workshop is appropriate for regulatory/medical communicators who are moderately experienced in writing clinical regulatory documents. The teaching style will be primarily lecture with an exercise and some opportunity for discussion. The workshop leader will focus on what regulatory/medical communicators need to know to effectively write the high-level clinical safety documents required specifically by the Food and Drug Administration for US New Drug Applications (NDAs), namely the Module 5.3.5.3 Report of Integrated Safety Analysis (ISS) vs the Module 2.7.4 Summary of Clinical Safety. Associated regulations and guidelines will be discussed, as well as the source documents and other tools needed for generating these documents. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Marijke Adams, PharmD, PhD, President, MH Adams & Associates, Inc., Davie, FL
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Development Process (RR/PH) [4010] This workshop is designed for novices to the pharmaceutical industry. Participants will learn about and discuss the drug development process with special emphasis given to regulatory and reporting requirements. Specifically, the workshop details the history behind drug regulation, the contents and maintenance of an Investigational New Drug Application (IND), Good Clinical Practice (GCP), the phases of human clinical trials, and the most recent regulations impacting drug development. The discussion will draw upon US, European, and International Conference on Harmonisation (ICH) guidelines and regulations. APPROXIMATE HOMEWORK TIME: 3–4 HOURS.
Kathy Spiegel, PhD, Amgen Inc., Grass Lake, MI
WS-24 | Writing a Protocol in Compliance with ICH
Guidelines (RR) [4018] Learn to write a protocol for a clinical trial that is compliant with the International Conference on Harmonisation (ICH) guidelines. The workshop leader will review the regulatory requirements, show participants how the use of templates can shorten protocol development time, and will provide information about each protocol section and how participants can obtain the information needed. Participants will learn how to gather information, manage the review process, and understand who will be using the protocol. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Paula Fischthal, MA, Senior Medical Writer II, MedImmune, a wholly owned subsidiary of AstraZeneca, PLC, Gaithersburg, MD
T e ch no l o gy
full program schedule | thursday WS-25 | Assessing and Communicating the Benefits
and Risks of Medicines (RR) [4021] We balance benefits and risks for every activity in daily life. Regulators, drug developers, clinicians, patients, payers, and other stakeholders attempt to apply benefit-risk (BR) assessments to medicines. Despite intuitive approaches, the formal evaluation of a medicine’s BR is a relatively new, continually emerging science. A common framework for assessing and communicating BR is quickly approaching. This course is designed to introduce participants to the concepts that underlie techniques to assess the BR of medicines and to apply this knowledge to ways writers can approach more effective BR communications with stakeholders. APPROXIMATE HOMEWORK TIME: 2 HOURS.
Lawrence Liberti, MS, RPh, RAC, Executive Director, CIRS, Holland, PA
WS-26 | Basics of Epidemiology (RR/EW/PH/SG)
[4001] Designed for experienced medical writers, this combination of lecture and group exercises is based on the principle that medical communicators have a key gatekeeper’s role in ensuring the correct interpretation of scientific findings. Participants will be provided with the ABCs of data interpretation according to basic epidemiological concepts and research techniques. The focus will be on the critical appraisal of reported medical findings and the application of epidemiological tenets to improve the participant’s writing. Measures of disease occurrence, research designs, and causality development will be discussed. The workshop leader will use examples from clinical medicine, public health, and pharmacoepidemiology. APPROXIMATE HOMEWORK TIME: 3–4 HOURS.
Jane Neff Rollins, MSPH, Arnell Communications, Montrose, CA
10:30 AM–3:00 PM EXHIBIT HALL OPEN
11:00 AM–12:00 PM OS-6 | Hands-on Demonstration: The ABCs of PDFs:
Introduction to Adobe Acrobat X/XI [Technology] This session will provide information about some best practices in using Acrobat X or XI, including creating user-friendly, high-quality, low-file-size PDFs from Microsoft Word so that readers can easily open, read, navigate sections, and make comments on a PDF document. Also learn how to edit text, use commenting tools, and make other changes in a PDF. Bring your laptop with Acrobat X or XI already installed (version IX is also acceptable). Tablets and iPads will not be good for this session, nor will Acrobat Reader.
Barbara Kristaponis, Graphic Designer/Writer (Principal, ZBKR.co) and Senior Portfolio Manager, New York Hall of Science, New York, NY
OS-7 | Current Regulatory Challenges for Reporting
Drug Safety Information for Approved Drugs, Biologics, and Devices [Regulatory] This seminar will provide an overview of the challenges with safety reporting given the recent legislation, including the Federal Food and Drug Administration Amendment Act (FDAAA), Risk Evaluation and Minimization Strategies, and the Trial and Experimental Studies Transparency (TEST) Act, and how these laws affect the peer-review publication. These acts have motivated the reform of safety reporting by the pharmaceutical industry but not the obligation to publish safety data in peer-reviewed journals. Publications emanating from observational pharmacovigilence activities (such as the Safety Registries) in the peerreviewed literature allow clinicians to make more informed decisions about approved drugs for their patients based on data that transcends the myopic
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ethics
full program schedule | thursday data acquired in pre-approval clinical trials. The obligation to publish safety data will be discussed in detail. Mary Whitman, PhD, Senior Director, Medical Affairs, Janssen Biotech, Inc., Spring House, PA
OS-8 | Diving into NLM Resources: Drugs, Images,
and Articles Abound [Other Skills] Bring your WiFi-enabled laptop, iPad, or tablet and join an experienced medical librarian representing the National Library of Medicine (NLM) who will update you on the Library’s latest information innovations, including its apps and mobile sites. Internet access will allow you to explore the Drug Information Portal and the new image database: Open-I; discover key tips on searching free online databases such as PubMed, MedlinePlus, and ClinicalTrials.gov; and learn where to find even more information and resources to make your background and literature searches more efficient.
Holly Ann Burt, MLIS, AHIP, Outreach and Exhibits Coordinator, NN/LM-Greater Midwest Region, Chicago, IL
OS-9 | Encore Presentation from the 2013 Council
of Science Editors Annual Meeting [Technology] “Scientific Podcasts: Why, When, What, Everywhere” Making content easy to consume helps ensure your message reaches end users in effective and satisfying ways. Podcasts are inherently mobile, allowing users to listen on their own timetable. Two case studies will help you decide whether podcasts will help your publication communicate your message effectively. You will learn what’s involved in creating a podcast, how to access statistical data about downloads and usage of podcasts, and how archives of podcasts may be used.
Christopher Lowe, Managing Editor, American Gastroenterological Association, Bethesda, MD Sheehan Misko, Managing Editor, American Association for Clinical Chemistry, Washington, DC
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OS-10 | Evidence-Based Instructional Design: Practical Tips for the Occasional Educator [Continuing Education for Health Professionals] As medical writers, our credibility hinges on the strength of the evidence behind our written words. Yet, when we are called on to transform medical information into medical education, we often utilize approaches based on educational folklore and habit. Using the works of leading educational researchers, you will work through two case studies and learn how to create meaningful educational material (both a classroom workshop and an e-learning module) without having to become a software expert. Karen Steinhilber, MLS, Manager, Instructional Design and E-Learning, Biotronik, Ramsey, MN
OS-11 | Networking to Great Career Opportunities
[Professional Relationships] Networking is the crux of any successful job search strategy. It’s also how you build powerful connections that accelerate your career. Join a master networker who will describe how to transform those first tentative conversations into a spiderweb of connections that catches jobs and career opportunities. Learn how to work the room—the right way, get the conversation rolling, gracefully exit a conversation, make the most of a networking event, turn one-on-one meetings into powerful connections, and avoid the “third rail” that can destroy networking connections. John West Hadley, Career Search Counselor, John Hadley Associates, LLC, www.JHACareers.com, Somerville, NJ
OS-12 | Qualify your Clients and Increase your
Bottom Line [Freelance] If you’re a freelance writer, chances are you’ve had one or two challenging clients. You know, the client who doesn’t comprehend the idea of scope creep and who expects 24-hour turnaround for last-minute requests. Is there a way to spot such a client before you sign up
Career development
full program schedule | thursday to work with them? Yes! This seminar outlines strategies you can use to qualify your prospects before you take them on as clients. We’ll review cases that illustrate red flags to watch out for, discuss the characteristics of ideal clients, and generate questions you can use with your prospects to gather information you need to make a qualified decision about whether to work with a potential client. Alexandra Howson, MA, PhD, CCMEP, Owner, Thistle Editorial, LLC, Snoqualmie, WA Kristen L. Phiel, MS, Independent Medical Writer, Denver, CO
11:30–12:00 PM OS-13 | Hands-on Demonstration: Word 2010 -
Formatting the Perfect Document [Technology] Microsoft’s Word 2010 is rapidly becoming the new standard, and more and more companies are transferring their documents and templates to Word 2010. To keep up with these technologic changes and industry advances, medical writers need ongoing training in Word 2010 to keep their skills sharp. Learn basic but essential skills for developing the perfect publishingready document. Bring your laptop with Microsoft Word 2010 already installed. Kathia Yurchak, MS, Associate Scientific Medical Writer, Bayer Healthcare Pharmaceuticals, Montville, NJ
12:15–1:30 PM
NETWORKING LUNCH in the Exhibit Hall Free ticketed event, advance registration required
12:15–1:30 PM
AMWA Workshop Leader Lunch and Program: For All Current and Potential Workshop Leaders (free ticketed event, advance registration required) Would you like some tips for leading an AMWA workshop? Are you interested in becoming an AMWA workshop leader? Come enjoy a box lunch and learn how to become a workshop leader, how to handle some
challenging situations, and how to make a workshop successful. Moderators: Helen Hodgson, PhD, Westminster College, Draper, UT Marianne Mallia, ELS, Scientific Publications, Texas Heart Institute, Houston, TX Panelists: Susan Aiello, DVM, ELS, Merck & Co Inc., Dayton, OH Brian Bass, Bass Global, Inc., Robbinsville, NJ Hope Lafferty, AM, ELS, Hope Lafferty Communication
1:30–2:00 PM OS-14 | Hands-on Demonstration: Yahoo, Gmail,
Comcast...What Does Your E-mail Domain Tell Your Potential Clients? [Technology] You’ve got mail! As a freelance medical writer, you rely heavily on correspondence via e-mail. How might your e-mail domain be hindering your career/business by giving your prospective clients the wrong impression? AOL, Yahoo, Gmail, and Comcast are free e-mail services, but they may be telling your client that you are behind the times or only a writer “on-the-side.” Obtaining your own unique domain name and customized e-mail address is a cost-effective addition to your marketing plan. Bring your WiFi-enabled laptop and be guided through the process of registering a domain and setting up e-mail hosting. Tracy E. Bunting-Early, PhD, Principal, Bunting Medical Communications, Inc., Newark, NJ
1:30–2:30 PM OS-15 | Bite the Bullet: How Not to Kill Your
Presentation with Your Slides [Other Skills] Most presentation slides are deadly, if not fatal, for two reasons. First, presenters don’t realize the power of this visual medium and often “shovel in” too much information, which defeats the purpose of helping the audience understand what is being presented. Second, presenters don’t understand the basic functionality of PowerPoint. The result is glaring animation mistakes and amateurish
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n e t wo r k i ng
full program schedule | thursday navigation. Learn how to better structure and organize your message. synthesize your visual and verbal messages, and avoid the deadliest sins of PowerPoint. Elizabeth G. Frick, PhD, ELS, President/CEO, The Text Doctor LLC, Boulder, CO
OS-16 | Dial 911: More Emergencies in Medical
Writing [Freelance] Back for the third straight year, this popular seminar will include the presentation of eight to 10 real-life scenarios—involving logistical, technologic, or other unexpected challenges—that constituted an “emergency” in medical writing. Participants will be asked to brainstorm and suggest solutions to each emergency. The seminar leaders will offer strategies for implementing safeguards to prevent common pitfalls in medical writing projects, recognizing the subtle red flags that signal imminent emergencies, and developing solutions for addressing medical writing emergencies with professionalism. Anne Jacobson, MPH, CCMEP, Independent Medical Writer, Cocoa Beach, FL Scott Kober, MBA, CCMEP, Director, Content Development, Institute for Continuing Health Education, Philadelphia, PA
OS-17 | Hands-on Demonstration: EndNote for
Intermediate Users [Technology] Gain hands-on experience with topics such as creating and modifying output styles and working more effectively with other EndNote users. There will be time for participants to ask “how to” questions of their own. Bring your laptop with EndNote (version X4 or later) and Microsoft Word (2007 or later) already installed, and at least one EndNote library containing some references. Stephen N. Palmer, PhD, ELS, Senior Scientific Writer, Scientific Publications, Texas Heart Institute, Houston, TX
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OS-18 | How to Write a Manuscript from a CSR [Writing/Editing] Clinical study reports (CSRs) are often thousands of pages in length. Distilling these tomes into a concise and meaningful 2,500-word manuscript for publication in a peer-reviewed journal can be a daunting task for a medical writer. In this seminar, you will learn about the components of the CSR and how to efficiently identify the CSR content that should be included in a manuscript. The CONSORT guidelines, which guide manuscript preparation, will be explained, and the important role of the medical writer throughout the process will be discussed. Brian Bass, President, Bass Global, Inc., Robbinsville, NJ Cyndy L. Kryder, MS, CCC-Sp, Medical Communications Specialist, Phoenixville, PA
OS-19 | Tweeting, Blogging, SEO, and Strategy:
Online Content Planning for Medical Editors [Technology] Senior editors and editorial directors who work for online medical journals, news outlets, and other online sources must expand their knowledge base to incorporate the current digital and social media strategies and tactics into the content plan. With the use of social media tools, such as Twitter, and new criteria to determine content rankings in search engine results, the standards for content have been raised to remain competitive. The editor’s toolbox now requires a working knowledge and familiarity with content strategy, information architecture, search engine optimization (SEO), social media marketing, and analytics/metrics to collaborate effectively with marketing and information technology and to create marketable content. This seminar will provide an overview about online content planning, social media marketing, and editing. You will learn how to integrate these strategies into the editorial process to promote content in search engines,
CME
full program schedule | thursday improve quality, and increase user engagement. Brande N. Martin, MA, Content Manager, College of American Pathologists, Northfield, IL
about a unified content strategy, key concepts of effective mobile design, how to design adaptive content to support your content strategy, and tools to help you create mobile content.
1:30–3:00 PM OS-20 | Encore Presentations from the 2013
Ann Rockley, MIS, CEO, The Rockley Group Inc., Schomberg, ON
Society for Technical Communication Summit [Writing/Editing]
“Purposes, Personas, Conversations: Practical Techniques for Everything You Write” Whether you write for online or print, everything you write is part of a conversation between author and reader. Whether you write for patients or health professionals, you are conversing with them. Even if you write for print, your readers’ expectations are likely to be influenced by what they read and hear on websites, in mobile apps, in social media. And that is ever more conversational. Learn about the power of thinking of your writing as a conversation; how to make sure that your purposes are measurable, specific, and focused on your readers; the value of always having those people with you (even as “mini-personas”); and how walking those personas through their conversations helps you get the right interaction, the right design, the right copy to both satisfy their needs and achieve your goals. You’ll come away with new tools for everything you write. Janice (Ginny) Redish, PhD, Redish & Associates, Inc., Bethesda, MD
“Content Strategy for Mobile Devices” Smartphones, eBook readers, and tablets have forever changed the way people access and interact with your content. You need to be able to create content today that can adapt to the new devices of tomorrow. To do that you need to create a unified content strategy–a content strategy that takes into account the requirements of the customer, the content to be delivered, and the ever changing array of devices for delivery. Learn
OS-21 | Establishing and Maintaining an Effective
Mentoring and Coaching Program for Medical Writers [Career Development] You will learn how to develop and maintain an effective mentoring/coaching program for medical writers. Essentials for effective mentoring of both newly hired and long-term employees will be presented as part of a detailed training plan. The panel will also discuss the mentor’s/coach’s role in training and guiding the mentee in job skills, “soft skills,” corporate etiquette, people management skills, project management, and personal development. Moderator (and speaker): Sharyn Batey, PharmD, MSPH, Associate Director, Medical Writing Services Americas, PAREXEL International, San Diego, CA Naveen Arjunwadkar, BAMS, Assistant Manager, Medical Writing, SIRO Clinpharm, Pvt. Ltd., Mumbai, India Vatsal Shah, MBBS, MD, Vice President & Global Head, Medical Writing & Pharmacovigilance, SIRO Clinpharm, Pvt. Ltd.
OS-22 | Speed Networking [Professional Relationships] This session allows you to get acquainted with colleagues in a structured way. You’ll sit with another person at a small table and have 5 minutes to share your professional and personal interests. Then one of you will quickly move to the next table. This is NOT about job-hunting; participants will not be divided between job seekers and hiring managers. Rather, this session fosters serendipity—you never know whom you’ll meet, what interests you’ll share, and whether
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slide design
full program schedule | THURSday you might develop a business relationship or a friendship! Bring lots of business cards. Please arrive on time and stay for the whole session. Both newer and established members are encouraged to attend. Limited to 60 participants. Faith Reidenbach, ELS, CMPP, Partner, Caley-Reidenbach Consulting, LLP, Philomath, OR Helen Rowse, MD, MS, Medical Writer/Editor, Scottsdale, AZ
OS-23 | The West and the Rest: Working with
Non-Native English Authors and Readers in Asia and Eastern Europe [Writing/Editing] The demand is growing for people who can write clear, understandable English in an international context. However, most authors and readers of the international scientific literature in English are not native speakers of English, and clients are beginning to recognize the need to address an international marketplace. Clear, understandable English may not be exactly the same as “native English speaker” English. You will learn how to help clients get the English that they need, not necessarily the English that sounds most elegant to a native speaker. Presentations will focus on the challenges and opportunities of writing for this emerging market and ways to avoid some pitfalls. This panel discussion will be of most value to freelance writers who want to make their services more attractive to ESL authors, to inhouse writers of documents for international readership, and to managers who want to improve their inhouse and outsourcing strategies for the writing of internationally targeted documents. Moderator: Noelle H. Demas, MS, Independent Medical Writer, Panorama MedWriters Group, Inc., San Diego, CA Lee Seaman, President, Seaman Medical, Inc., Bellingham, WA Mary (Mimi) Wessling, MS, PhD, ELS, Consultant, Language Matters Santa Cruz, Corralitos, CA Mieko Onuki, President, EDIT, Inc., Tokyo, Japan
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3:00–3:30 PM
SPONSORED BEVERAGE BREAK in the Exhibit Hall
3:30–5:00 PM
KEYNOTE SESSION WITH ALVAREZ AWARD ADDRESS Introduction of the Alvarez Award Recipient: The Walter C. Alvarez Award is given annually to a person known for excellence in communicating health care developments and concepts to the public. Recipient: Gregory D. Curfman, MD, Executive Editor, New England Journal of Medicine Alvarez Award Address: Medical Devices: Policy and Politics After a description of the history, mission, and operations of the prestigious New England Journal of Medicine, Dr Curfman will discuss the safety and regulation of medical devices. Drawing on testimony he has given in the US Senate and House of Representatives, he will compare and contrast the regulation of drugs and devices and highlight problems in device regulation and discuss future directions in device regulation in order to improve safety and efficacy.
5:00–6:00 PM
NETWORKING RECEPTION in the Exhibit Hall Join your fellow attendees in enjoying light hors d’oeuvres and a cash bar, visiting exhibitors, and browsing the posters.
6:15 PM
CHAPTER GREET & GO Meet up with your chapter colleagues before heading out for dinner.
ma r k e t i ng
full program schedule | FRIday Friday, November 8 7:00 AM–4:00 PM
CONFERENCE REGISTRATION AND AMWA INFORMATION DESK OPEN
7:30–11:00 AM
EXHIBIT HALL OPEN Networking Breakfast with the Exhibitors: 7:30–9:00 AM A good breakfast paves the way for an engaged mind! Enjoy a complimentary continental breakfast with the conference exhibitors. The Passport Prize Awards drawing will begin at 8:30 AM. You must be present to win. Visit with the Poster Presenters: 7:30–9:00 AM Take advantage of this time to discuss the posters with their authors. The following posters have been accepted for display. Creative Tools for Collaborative Editing Sara Moreno, Quality Assurance Editor, Red Nucleus, Hamilton, NJ Evaluation of Indiana Health Industry for Use of Medical Writers Laura Oberthur Johnson, PhD, Medical Writer, OptumInsight, Sheridan, IN Identifying the Types and Severity of Problems in Biomedical Research Manuscripts Using a 14-Item Scale Jill Delsigne, PhD, Associate Scientific Editor, Department of Scientific Publications, The University of Texas MD Anderson Cancer Center, Houston, TX Late-Phase Clinical Studies: Time to Pass the New Templates and Align with the Guidelines Laura Oberthur Johnson, PhD, Medical Writer, OptumInsight, Sheridan, IN Letting the Patient Speak: Best Practices in Developing Shared Decision-Making Communication Tools for Patients Lora Arduser, PhD, Assistant Professor, and Mark Eckman, MD, Professor of Medicine; University of Cincinnati, Cincinnati, OH
A Question of Style: How Medicine, Science, and Social Science Style Guides Differ Emily Mahan, MFA, Associate Editor, and Sandra Ripley Distelhorst, ELS, Senior Editor; Northwest Health Communications, Vashon, WA Understanding Persuasion: Developing Communication Strategies to Address Vaccination and Prenatal Testing Heidi Lawrence, MA, Assistant Professor, George Mason University, Manassas, VA; and Amy R. Reed, PhD, Assistant Professor, Rowan University, Glassboro, NJ UX Design Lessons for Medical Writers Kristen Hines, Research Author, Canadian Medical Protective Association, Ottawa, ON Writing Research: Teaching ESL Writers Metadiscourse Cues for Medical English Neslihan Önder, Lecturer, Uludağ University School of Foreign Languages, Bursa, Turkey; and Bernadette Longo, Associate Professor, New Jersey Institute of Technology, Newark, NJ
9:00–10:30 AM OS-24 | FDA’s Other Box: Medical Device Regulation
for Pharmaceutical Writers [Regulatory] Many AMWA members are familiar with FDA regulation of pharmaceuticals and biologics, but if you’ve ever considered writing for the medical device and diagnostics industries, you’ll want to attend this seminar first. Learn about the Center for Devices and Radiological Health (CDRH), and the differences and similarities in how the FDA regulates drugs, devices, and diagnostics. The panelists’ goal is to inspire you to think outside the pharmaceutical industry box. Moderator: Jeanne K. McAdara-Berkowitz, PhD, Principal, Biolexica LLC, Longmont, CO Tim Peoples, MA, ELS, CMPP, Senior Medical Writer, Medtronic Inc., Santa Rosa, CA Felicia R. Cochran, PhD, Principal Clinical Research Specialist, Medtronic Neuromodulation, Minneapolis, MN Cynthia Carr, PhD,Senior Medical Writer, Ventana Medical Systems, Inc., Tucson, AZ
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full program schedule | FRIday OS-25 | Getting Published: A Discussion with Editors
of Medical Communication Publications [Career Development] The instructions for authors can tell you the basics of what a publication is all about, but nothing beats the chance to hear about it first hand from the editor. This panel presentation features editors from publications— including the AMWA Journal—that specifically address medical communication. Who is the publication’s target audience? Which topics are of highest priority? What helps a submission get accepted? What is involved in the review process? The editors will discuss these issues and more. Participants will be encouraged to ask questions and offer ideas on topics they would like to read about. Moderator (and speaker): Vicki White, Editor, AMWA Journal
Mario R. Nacinovich, Jr., MSc, Former Editor-in-Chief, Journal of Communication in Healthcare; Managing Partner, AXON Marissa Seligman, Editor, ACEHP Almanac Patricia K. Baskin, MS, Editor, Science Editor
OS-26 | Holistic Strategies for the Biomedical Manuscript: Collaboration of Art, Editing, and Journalism [Writing/Editing] For 20 years, this artist, editor, and journalist have provided medical illustration and writing/editing support for hundreds of neuroscience authors. They will describe their collaborative, holistic approach to translating biomedical manuscripts into news releases and subsequent media coverage. Learn how to work with and manage authors, including reluctant ones or novice residents; resolve author conflicts and ethical dilemmas; and handle copyright and permissions for art and figures. The panel members will describe cases to stimulate your questions and open discussion. Moderator (and speaker): Tonya Hines, CMI, Art Director, Medical Communications, Mayfield Clinic, Cincinnati, OH Mary Kemper, BS, Medical Editor, Medical Communications, Mayfield Clinic, Cincinnati, OH
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Cindy Starr, MSJ, Media Relations Specialist/Blogger, Medical Communications, Mayfield Clinic, Cincinnati, OH
OS-27 | Leveraging the Talent in the Editorial
Freelancers Association (EFA): What Editorial Professionals Can Do For You [Writing/Editing] The EFA offers medical writers a wealth of services, from professional editors to proofreaders to fact checkers, and serves as a valuable sister organization for AMWA members, especially those who are primarily editors. Panel presenters, who belong to both AMWA and EFA, will discuss the differences between editing and proofreading, elucidate levels of editing, and define editing tasks (eg, reviewing and correcting spelling, grammar, punctuation, consistency, formatting, word choice, flow, organization). Learn more about the process of fact checking for medical-regulatory-legal (MRL) review of pharmaceutical branded and unbranded promotional materials and verifying annotations. Panel members will also suggest tips for vetting an editor/ proofreader/fact checker and offer sample questions that editors and clients can use to outline a project scope and services required. You’ll leave this panel presentation armed with tools and websites to help improve and streamline editing and proofreading tasks. Moderator (and speaker): Jennifer G. Maybin, MA, ELS, President, Maybin Healthcare Communications, LLC, Branchburg, NJ Melissa L. Bogen, ELS, Owner, Bogen Editorial Services, Chester, NY Julie A. Munden, Owner/Senior Medical Editor, Blue Ink Communications, Souderton, PA
OS-28 | MBA for Freelances [Freelance] Are you running your business as, well, a business? What is your business plan? What are the strengths and weakness of your business? Opportunities and threats? Marketing plan? How do you handle financial issues like taxes, disability and life insurance, and
f r e e l a nc i ng
full program schedule | FRIday retirement planning? If you don’t know the answer to any of these questions—or have other questions you need answered—then you need this seminar. You’ll hear from a small business expert, a freelance medical writer, and a financial consultant about what you need to be a successful business. It doesn’t matter how good you are at writing. If you’re not just as good at running a business, you’re in trouble. Moderator (and speaker): Debra Gordon, MS, President, GordonSquared, Inc., Williamsburg, VA Scott Kober, MBA, CCMEP, Director, Content Development, Institute for Continuing Healthcare Education, Philadelphia, PA Additional speaker to be determined
OS-29 | New Opportunities for Medical Writers [Writing/Editing] This panel presentation will introduce you to two areas of medical writing: the field of health technology assessment (HTA) and the development of consensus manuscripts. Learn about the role of HTA in clinical and policy decision-making, the development of “value dossiers” as they relate to HTA decision-making, and how to develop the key components of consensus manuscripts and accurately capture consensus panel deliberations and translate the information into recommendations and supporting text. Moderator (and speaker): Lawrence E Liberti, MS, RPh, CIRS (Centre for Innovation in Regulatory Science), Holland, PA Julie Birt, PharmD, Senior Research Scientist, Global Health Outcomes, Health Technology Assessment-Center of Expertise, Eli Lilly and Company, Indianapolis, IN Sandra Ripley Distelhorst, ELS, Senior Medical Writer and Editor, Northwest Health Communications, Edmonds, WA
9:00–11:45 AM
Ticketed event, with additional fee IS-3 | Intensive Seminar: Seek and Find: NLM PubMed Is Only the Beginning [Other Skills] Bring your WiFi-enabled laptop, iPad, or tablet to this comprehensive hands-on seminar to follow along as an experienced medical librarian representing the National Library of Medicine (NLM) demonstrates extensive NLM databases, all free and online, and updates you on the latest advances to the PubMed database and My NCBI tool. You will have the opportunity to practice and improve your searching techniques: discover why keywords may fail, develop quick searches for evidence-based research, create e-mail alerts for the latest topics, and add library filters to personalize PubMed. Learn how to successfully search other NLM databases such as MedlinePlus, ClinicalTrials.gov, and PubMed Health for needed information. Bring your questions too! Limited to 60 participants. Holly Ann Burt, MLIS, AHIP, Outreach and Exhibits Coordinator, NN/LM-Greater Midwest Region, Chicago, IL
9:00 AM–12:00 PM WS-27 | Current Trends in Drug Regulations (ADV)
[728] Pharmaceutical manufacturers are under increasing pressure to develop and market drugs as quickly as possible. At the same time, they must anticipate future regulations, comply with newly effective regulations, and design and implement high-quality drug development programs. These changes include FDA’s structured benefit-risk assessment, FDA’s modifications to Risk Evaluation and Mitigation Strategies (REMS) requirements, issuance of new biosimilars guidances, breakthrough therapy designation, and the development of adaptive licensing and new pharmacovigilence legislation. This advanced workshop is designed for experienced writers who are familiar
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r e g u l at o ry w r i t i ng
full program schedule | FRIday with the regulatory aspects of drug development. It provides an overview of recent regulatory changes and how these impact the drug development process. Participants will discuss how they and their companies have been affected by, and made accommodations for, these developments. APPROXIMATE HOMEWORK TIME: 3-4 HOURS. Aaron Bernstein, PhD, Director, Medical Writing, Warner Chilcott, Rockaway, NJ
WS-28 | Macroediting (ADV) [713]
This workshop is for experienced editors. Participants will analyze the content and organization of a complete manuscript as a precourse exercise; during the course, participants will compare their skills with those of other experienced manuscript editors by reviewing the exercise together and learning about the art of macroediting. Recommended: Completion of the workshops Effective Paragraphing, Writing Abstracts, Tables and Graphs, and Organizing the Biomedical Paper; or at least 3 years’ experience in macroediting. APPROXIMATE HOMEWORK TIME: 3–5 HOURS.
Elliott Churchill, MS, MA, President, A World of Words, Atlanta, GA
WS-29 | Punctuation for Clarity and Style (ES/G)
[2008] Designed for communicators whose professional writing experience and grammatical savvy range from minimal to moderate, this discussion of the most useful punctuation rules and options—from the serial comma to the dash—will focus on emphasis, variety, and consistency. Medically oriented examples, including many sent in by participants, will be discussed. APPROXIMATE HOMEWORK TIME: 2 HOURS. Same as WS-69.
Susan E. Aiello, DVM, ELS, Editor-in-Chief, The Merck Veterinary Manual, Merck & Co, Inc., Bluebell, PA
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WS-30 | Statistics for Medical Writers and Editors
(ES/G/SG) [2010] This workshop is designed for participants who have little or no background in statistics. Elementary statistical concepts needed to understand medical and scientific articles will be covered, including types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and Student’s t test. Emphasis will be placed on understanding statistical presentations and on reporting statistical information, not on calculations or mathematical explanations. APPROXIMATE HOMEWORK TIME: 3 HOURS. Same as WS-10. Bart Harvey, MD, PhD, University of Toronto, Toronto, ON
WS-31 | Basic Grammar I (ES/G) [2000]
Thorough knowledge of parts of speech is truly basic to good writing and editing. This workshop focuses entirely on parts of speech and their use in the sentence. Types of nouns and pronouns, verb tense, pronouns and case, phrases and clauses (with special emphasis on verbals and on noun, adjective, and adverb clauses), and the types of sentences are some of the primary topics that the workshop covers. Information in this workshop is, in essence, basic to every other AMWA workshop. APPROXIMATE HOMEWORK TIME: 2 HOURS. Same as WS-12.
Jude Richard, ELS, Synchrogenix Information Strategies Inc., Austin, TX Chrissie Worth, MA, ELS, Communications Advisor, South Calgary Primary Care Network, Calgary, AB
WS-32 | Essential Ethics for Medical Communicators (ES) [2006] This workshop is required for individuals working to earn the Essential Skills certificate. The workshop leader will provide a basic overview of ethical considerations with a focus on the AMWA Code of Ethics. The workshop comprises a homework assignment, an
H e a lt h l i t e r ac y
full program schedule | FRIday interactive lecture, and a class exercise—all designed to address the variety of ethical situations that occur in medical communication. Participants will be divided into small groups to discuss the case studies submitted as homework assignments, name the ethical problem, identify the involved stakeholders and their perspectives, debate alternative decisions, and use role-playing to present to the entire group. This workshop is suitable for both entry-level and experienced medical communicators. APPROXIMATE HOMEWORK TIME: 3 HOURS. Same as WS-67. Jill Shuman, MS, ELS, Tufts University, Boston, MA
WS-33 | Basic Grammar II and Usage (ES/G) [2001]
Customary practice, particularly with respect to language, can sometimes lead to unclear writing, especially when the writer is tempted to use informal or nonstandard English. This workshop builds on Basic Grammar I by reviewing additional grammatical topics and by discussing some aspects of English usage. Correcting dangling or misplaced modifiers, using who or whom and which or that, making subjects agree with verbs, writing clear comparisons, and choosing the correct word are topics addressed in this workshop. APPROXIMATE HOMEWORK TIME: 3 HOURS. Same as WS-71.
Anne Marie Weber-Main, PhD, Assistant Professor of Medicine, University of Minnesota, Minneapolis, MN
WS-34 | Preparing CME Materials: Concepts,
Strategies, and Ethical Issues (CP/EW/FL) [3012] Beginning to advanced medical writers are often involved in the preparation of educational-needs assessments, learning objectives, and content for continuing medical education (CME) activities. Writers need to have a working knowledge of how and why CME is developed, the main stakeholders in the process, and the roles of sponsors and supporters. In view of the ethical issues that may arise with the increasing role of pharmaceutical companies in providing CME grant support,
writers need to be familiar with the guidelines set by the American Council on Continuing Medical Education, the American Medical Association, and other organizations. These important topics will be conveyed through lecture, practical examples, case studies, and discussion. APPROXIMATE HOMEWORK TIME: 3 HOURS. Marcello A. Morgan, MD, CCMEP, Medical Director, Advanced Studies in Medicine, Summit, NJ Eve Johnson Wilson, PhD, CCMEP, Independent Medical Writer/Editor, MORPHOS Medical Education, LLC, Bowie, MD
WS-35 | Organizing the Medical Paper (CP/EW/FL)
[3010] This basic workshop for authors, authors’ editors, and journal editors will examine the principles of organizing original research reports for publication. Lecture, discussion, and exercises will be used to teach participants about the function and content of each section of a biomedical paper, the value of clarity within each secion, and the importance of tying each of the sections togther. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Janice Sabatine, PhD, President, Avanti Strategies LLC, Cranberry Township, PA Thomas Annesley, PhD, Professor, University of Michigan, Ann Arbor, MI
WS-36 | Essentials of Copyediting (CP/EW) [3003]
Intended for beginning copyeditors, this workshop will focus on basic copyediting skills. Copyediting is the process by which a manuscript is prepared for publication by revisions that ensure clarity, accuracy, and consistency. Participants will learn the elements, principles, and processes involved in copyediting for scientific and medical publications. Specific exercises will enable participants to identify typical copy problems and compare various editorial choices. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Flo Witte, PhD, ELS, Bluegrass Editorial Services Team, Winchester, KY
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full program schedule | FRIday WS-37 | Basic Laboratory Methods in the Biological Sciences (SM) [3502] This workshop is aimed at beginning and moderately experienced science editors and writers. Through lecture and discussion, the workshop leader will explain a number of basic laboratory methods that are used in biological sciences research. The leader will review key terms and there will be a brief discussion of useful resources. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Dominic De Bellis, PhD, Senior Associate Director, Medical Writing, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
WS-38 | Basics of Human Anatomy and Physiology
(SM/EW/PH/SG) [3503] This workshop is suitable for the beginning and moderately experienced writer or editor. The workshop leader will offer basic knowledge of human anatomy and physiology through lecture and discussion. Organization of the human body, from molecular to system levels, will be covered. APPROXIMATE HOMEWORK TIME: 2 HOURS.
MaryAnn Foote, PhD, MA Foote Associates, Westlake Village, CA
WS-39 | Drug Interactions (SM/EW/PH/SDT) [3508]
Drug interactions can be beneficial as well as harmful. The workshop leader will address the hows and whys of drug interactions—good and bad, pharmacokinetic and pharmacodynamic mechanisms, basic explanations of key concepts of pharmacokinetics and pharmacodynamics, and the role of genetics in drug interactions (pharmacogenomics). This is introductory information intended for writers and editors with no formal training in drug interactions or pharmacokinetics. APPROXIMATE HOMEWORK TIME: 2 HOURS.
Gayle Nicholas Scott, PharmD, ELS, Principal Medical Writer, UBC-Envision, Southport, CT
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WS-40 | Communicating Results of Routine Clinical
Laboratory Tests (SM/EW/PH/SDT) [3506] The workshop is appropriate for inexperienced to moderately experienced writers. The workshop leader will cover basic concepts pertaining to laboratory terminology, including the components of a complete blood count and serum chemistry profile and their relationship to organ systems, with the goal of clear and concise communication of laboratory findings. Reviewing laboratory summary tables and data listings, as well as correlating test results to adverse events for summaries in regulatory documents, are also covered. Although application in regulatory writing will be emphasized, the concepts covered are also applicable to journal articles and other forms of medical writing. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Rita C Tomlin, BS (MT), MA, Tomlin Consulting LLC, San Diego, CA
WS-41 | Investigational New Drug Applications (RR/
PH) [4008] This workshop is intended for writers with little or no experience in preparing documents for regulatory applications. The leaders will cover the essential components of an investigational new drug application, FDA regulations, and the reviewers’ needs. Participants will also gain an understanding of the writer’s contribution to the quality of an electronic submission. Requirements and available online sources will be included. APPROXIMATE HOMEWORK TIME: 3–4 HOURS. Same as WS-80.
Jennifer Grodberg, PhD, RAC, Senior Director, Regulatory Affairs, Trius Therapeutics, Inc., San Diego, CA
WS-42 | Interventional and Observational Research Design (RR/EW/PH/SG) [4007] This workshop, intended for beginning medical writers who are inexperienced in clinical research design, will cover research trial designs used in the two primary
health communication
full program schedule | FRIday types of investigations conducted by pharmaceutical companies, interventional and observational trials. Basic study designs will be categorized, characterized, and contrasted. Examples from the medical literature will be used to offer insight into judging design strengths and shortcomings. Participants will critique prototypical studies. APPROXIMATE HOMEWORK TIME: 3 HOURS. Michael L. Jones, MS, Director of Medical Writing. TKL Research, Inc., Rochelle Park, NJ Mary H. Whitman, MS, PhD, Senior Director, Medical Affairs, Janssen, Spring House, PA
WS-43 | Electronic Common Technical Document
(RR/PH) [4004] This workshop is appropriate for regulatory/medical writers who have minimal or moderate experience in preparing documents for a pharmaceutical eCTD (electronic common technical document) regulatory submission. The teaching style will be primarily lecture with an exercise and some opportunity for discussion. The workshop leader will focus on what writers need to know to support team efforts for preparing regulatory documents slated for investigational and new drug marketing applications. Topics for discussion will include associated regulations and guidelines, the structure and format of the eCTD, and best practices for writing the documents that constitute the submission. APPROXIMATE HOMEWORK TIME: 1.5–3 HOURS.
Nancy R. Katz, PhD, President & Principal Medical Writing Consultant, Illyria Consulting Group, Inc., Soda Springs, CA
WS-44 | Writing an Investigator Brochure (RR/PH)
[4015] This workshop is intended for moderately experienced to advanced writers in the pharmaceutical industry who want to improve their understanding of the investigator brochure (IB). The workshop leader will focus on the regulatory and informational needs of the audience
and how to use best practices to communicate information on the drug. Relevant regulations will be reviewed, and required topics discussed. The evolution of the IB from phase 1 to phase 4 will be elucidated. A discussion will focus on how to prepare an IB using subject matter experts. APPROXIMATE HOMEWORK TIME: 3–4 HOURS. Jane Stephenson, PhD, MBA, Director of Medical Writing, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
11:00 AM–12:00 PM OS-30 | AMWA’s Certification Commission:
Where We’ve Been and Where We’re Going [Career Development] Learn about the Certification Commission’s activities over the past year, including an update on exam development, as well as topics such as rules for candidate eligibility, a study guide, and governance policies for the Commission. What’s more, you can find out how to become part of this groundbreaking initiative to help define professional standards in our profession. There will be time for questions and answers on the certification process. Karen Potvin Klein, MA, ELS, Certification Commission Chair, Wake Forest University Health Sciences, Winston-Salem, NC
OS-31 | Do You Need a Brand? [Freelance]
This seminar will be an interactive discussion of what a personal brand represents for medical writers both in industry positions and freelancing and how to build a strong, likeable brand. Topics will include how to create continuity and polish of that brand across all aspects of interaction: e-mail; social media (focusing on Linked In and Twitter); and in-person interactions, personal appearance, and “presence.” Learn about how to create, build, and enhance a brand and how likeability, appearance, and other “soft” skills influence the perception of competency and professionalism. Robin Whitsell, BA, BPh, President, Whitsell Innovations, Inc., Chapel Hill, NC
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full program schedule | FRIday OS-32 | The Great Freelance Rate Debate [Freelance]
Charging for freelance services is a hot, controversial topic. Are you on “Team Hourly Rate” or “Team Project Rate”? Perhaps you swing both ways? In this pro/con debate, two seasoned professionals with more than 50 years of combined freelance experience step up to the plate to settle once and for all (maybe) which way is the best approach to charge freelance fees. At stake: the title of World Champion Freelance. Come out, listen, learn, and support your team! Brian Bass, President, Bass Global Inc, Robbinsville, NJ
Alexandra Howson, MA, PhD, CCMEP, Owner, Thistle Editorial, LLC, Snoqualmie, WA
Elizabeth L. Smith, President, Smith Simon Company, Lyndhurst, VA
Tracy Bunting-Early, PhD, CCMEP, Principal, Bunting Medical Communications, Inc., Newark, DE
OS-33 | Realize the Power of Document
OS-35 | What Medical Writers Need to Know About CANCELED
Collaboration—and Ease the Pain of Medical Writing [Writing/Editing] Editing and reviewing often complex documents consumes considerable resources both within and outside the organization. This collaboration is usually implicitly assumed regardless of how it’s achieved. Although document creation and review is a critical process fraught with inefficiency and frustration, most still continue to work with manual processes or other workarounds, making it a constant struggle to meet deadlines. With a demonstration of the methodology used, supported by case studies and a discussion of available technology options, learn how to overcome these challenges by understanding the meaning, and realizing the power, of “true” document collaboration. David Cornwell, CEO, PleaseTech Ltd, Malmesbury, United Kingdom
OS-34 | Video Killed the Radio Star: How to Develop
Video Panel Moderator Guides [Writing/Editing] Online/digital broadcasting companies and live educational event providers work with medical device, pharmaceutical, and continuing medical education
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companies to produce video panel discussions on a variety of clinical, research, and procedural issues. Medical writers are typically hired to develop moderator guides or scripts to facilitate discussions and ensure coverage of agreed-upon subject parameters. The seminar leaders will take you through the development of a guide, and you will learn about the key elements of effective discussion guides and the markets for these guides.
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MedDRA [Regulatory] The Medical Dictionary for Regulatory Activities (MedDRA) is a standardized international terminology that is used by regulatory authorities and the biopharmaceutical industry to share safety information about medical products. Medical writers who are involved with any aspect of regulatory writing or medical publications need to understand how to “speak MedDRA.” This seminar will illustrate the value of MedDRA as a common language for communication of safety data in documents such as clinical study reports and safety summaries. You will first receive a refresher on the features of MedDRA (hierarchy, multi-axiality, etc). Then, through practical examples and interactive exercises, you will learn how to avoid missteps in the interpretation of safety data and optimize the presentation and analysis of MedDRA-coded data. There will also be an opportunity for you to compose a short “query” of MedDRA terms to address a safety signal. Judy E. Harrison, MD, Senior Medical Officer, MedDRA MSSO, Lebanon, NJ Marjorie Winters, President, Winters Editorial Services, Township of Washington, NJ
slide design
full program schedule | FRIday OS-36 | What’s in Your Genes? Looking at Genetic Disorders [Health and Medicine] Genetic diseases may be rare, but the number of people with genetic disorders is substantial. Most of us carry within our genome at least 10-15 potentially harmful genes; we have no awareness of them unless a rare condition appears in the family. This seminar features general information about human genetic disorders, including a brief introduction to genomics and proteomics and a discussion of the types of errors that can occur. You will learn through numerous examples of each type of disorder: single gene disorders, x-linked disorders, multiple gene disorders, and chromosomal aberrations.
F-2 | “You’re a Principal Medical Writer, So Now
What?” Participants will discuss areas of career development for experienced writers. Should you diversify or specialize? Should you focus on technical, document, or subject matter specialization? How do you diversify if you are already specialized and in high demand? Other topics include process improvement, mentoring, and project management. Please plan on discussing your ideas and experience. Please note that this roundtable discussion has been added since the original posting of the brochure.
Arlene Kray, PharmD, PhD, inVentiv Health Clinical, Pittsburgh, PA
Evelyn B. Kelly, PhD, Owner, Kelly Communications, Ocala, FL
11:00 AM–2:30 PM
EXHIBIT HALL AND POSTER TAKEDOWN
12:15–1:30 PM
ROUNDTABLE DISCUSSIONS WITH LUNCH (ticketed event, with additional fee) Roundtable discussions are led by a facilitator who has experience with the topic. The discussions are interactive, not didactic, and participants at each table are encouraged to share their experience and knowledge on the topic. Attendance is limited to nine participants at each table.
F-1 | The Benefits of Publication SOPs
Participants will discuss experiences in developing and abiding by standard operating procedures (SOPs), the pros and cons of having SOPs, how publication SOPs can address challenges faced by industry professionals, and how government-issued Corporate Integrity Agreements affect the publication process. This roundtable discussion is also offered on Thursday.
F-3 | Biosimilars: What Are They and How Will
They Affect Patients, Physicians, Pharmacists, and Medical Writers? Participants will learn how to describe biosimilars, the abbreviated FDA pathway for their approval, and the potential of biosimilars to increase patient access to off-patent biologic agents. Participants will also have the opportunity to discuss contrasting viewpoints on hot topics related to biosimilars, including product naming, pharmacovigliance, similarity, interchangeablitiy, and physician notification.
Micah Robinson, PhD, Amgen Inc., Thousand Oaks, CA
F-4 | Certification of Editors in the Life Sciences
Participants will learn about the Board of Editors in the Life Sciences and discuss certification, the procedure for becoming certified, preparation for the certification examination, and the examination itself.
Norman Grossblatt, ELS(D), The National Academies, Chevy Chase, MD
Jenilyn J. Virrey, PhD, Amgen Inc., Thousand Oaks, CA
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full program schedule | FRIday F-5 | Clinical Trials for Beginners
What kinds of issues should you look for when covering news about a clinical trial? Participants will discuss key elements of trials, focusing on ethical issues, and using real case studies as examples.
Judy Stone, MD, Scientific American Blog Network, Cumberland, MD
F-6 | Conducting Effective Document Review
Meetings Medical writers often facilitate the writing of documents where team members provide input. One way of bringing consensus is to review the document as a team during a team meeting. This roundtable discussion will focus on best practices in setting up, maintaining control, and conducting a productive document review meeting.
Noelle H. Demas, MS, Panorama MedWriters Group, Inc, San Diego, CA
F-7 | Desperately Seeking Standards: Tracking
Changes in PowerPoint Participants will share their experiences tracking changes in PowerPoint and discuss ways to meet client expectations and editorial challenges. This is not a tutorial in PowerPoint per se, but a facilitated discussion for those of us who regularly edit slide decks and have been frustrated with the limitations of the technology. By starting this conversation, we can learn how others in the field are using PowerPoint and begin to identify common—and best—practices. This roundtable discussion is also offered on Thursday.
Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Marfa, TX, and Nashville, TN
F-8 | Do We Really Need an Editor Anyway?
This roundtable discussion will focus on the value of having an editor as part of your team, as well as ways to measure an editor’s worth.
David M Clingan, inVentiv Health Clinical, San Antonio, TX
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F-9 | Electronic Archiving for the Home Office
Participants will learn to distinguish between “backing up” and archiving, be able to organize files and e-mails so that they can be quickly found and accessed, name software solutions for cataloging files and archiving e-mails, describe hardware options, explain the limitations of electronic media, and provide examples of when it is appropriate to use electronic media. This roundtable discussion is also offered on Thursday.
Kathy Spiegel, PhD, Amgen Inc., Grass Lake, MI
F-10 | Freelance Writing for the Medical Device Industry Participants will discuss segueing into writing about medical devices, including regulatory-jurisdictional distinctions between regulatory bodies; talk about differences between writing for medical devices and drugs/biologics; and share strategies for obtaining job leads. This roundtable discussion is repeated on Thursday. Jim Hudson, Medical Writing Associates, Simi Valley, CA
F-11 | From Academic Scientist to Freelance Writer:
Sharing Lessons Learned Participants will discuss the following for shifting to freelance medical writing: assessment of mindset and attitudes needed, analysis of plans to succeed and also avoid common mistakes, and organization of plans for initial purchases. Kathy Boltz, PhD, Phoenix, AZ
F-12 | Full, Abbreviated, or Synoptic: Which Type of
CSR to Use and When Participants will learn how to distinguish between full, abbreviated, and synoptic clinical study reports (CSRs); describe the benefits and drawbacks of using an abbreviated or synoptic CSR; identify what material should be included in an abbreviated or synoptic CSR; and formulate an algorithm to help determine which CSR would
social media
full program schedule | FRIday best fit the needs of the trial. Debra L. Stamper, PhD, Veristat, LLC, Holliston, MA
Sandra Ripley Distelhorst, ELS, Northwest Health Communications, Edmonds, WA
F-13 | Get All Those Eggs Out of Your Basket—
F-17 | Lost in Translation: Challenges for Basic
Diversifying Your Freelance Medical Writing Business and Increase Your Income Too many freelances rely on too few clients for their business. That way lies disaster. At this roundtable, learn about unexpected areas for freelance medical writing and the importance of diversification. Debra Gordon, MS, GordonSquared, Inc., Williamsburg, VA
F-14 | Getting to Know EndNote Aimed at relatively new users of EndNote, this discussion will focus on various ways of accomplishing different tasks in EndNote (eg, importing references directly into EndNote vs importing PubMed-generated text files vs entering references by hand) and when each of these methods is most advantageous. Participants will also learn some tips for using EndNote more effectively. Stephen Palmer, PhD, ELS, Scientific Publications, Texas Heart Institute at St. Luke’s Episcopal Hospital, Houston, TX
F-15 | How to Be a Successful Self-Employed
Medical Writer Participants will discuss the elements involved in operating their own successful business as a medical writer, how to make the transition to self-employment as a medical writer, and how to define the next steps to create a successful medical writing business. Ursula Jorch, MSc, MEd, Work Alchemy, Toronto, ON
F-16 | Impact Factors: What You Need to Know This discussion focuses on how impact factors are calculated and how they can be manipulated by editors and authors, alternative journal ranking systems, and the pros and cons of impact factors, including what major supporters and critics have to say.
Scientists in Designing and Writing Clinical Protocols and Consent Documents This discussion focuses on elements that are commonly deficient in clinical protocols written by basic scientists and the impact of these mistakes on regulatory review (FDA, IRB). Participants will share challenges and successful approaches for helping basic scientists write clinical protocols, such as the use of templates or formal training in trial design and protocol writing. E. M. (Mitch) Seymour, PhD, RAC, SciMedLit, LLC, Michigan Institute for Clinical and Health Research, Ann Arbor, MI
F-18 | Medical Illustrators: The Other Medical
Communicators Participants will learn how illustrations and data visualizations go beyond documentation to elucidate meaning and understanding and how to recognize visual complexity that aids or hinders the effectiveness of an image. Discussion will also address the qualifications and practices of medical illustrators compared with commercial artists and industry problems with infringement. Tonya Hines, CMI, Medical Communications, Mayfield Clinic, Cincinnati, OH; Association of Medical Illustrators
F-19 | Medical Journalism Do’s and Don’ts: Tips for
Successful Reporting and Writing This roundtable focuses on tips to help participants write magazine and other types of articles on medical topics for the public. Topics include the process of gathering and evaluating information for the articles, writing the articles, and addressing ethical and other issues that the writer may encounter. This roundtable discussion is also offered on Thursday. Barbara Gastel, MD, MPH, Texas A&M University, College Station, TX
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full program schedule | FRIday F-20 | Mining the Internet: Online Resources for Medical Communicators Participants will discuss where to find up-to-date demographic data, basic disease state information, clinical practice guidelines, health surveillance data, and more on the Internet. The focus will be on resources that are acceptable for medical-regulatorylegal (MRL) review, websites to avoid, and tools that can enhance productivity and time management. This roundtable discussion is also offered on Thursday.
F-24 | So, You’ve Hired a New Medical Writer: How to Do a Good Job of Onboarding Participants will discuss how to effectively onboard a new or transitioning medical writer so he or she becomes a productive, efficient, and credible member of your organization. Topics include the benefits and challenges of a structured onboarding process, as well as the elements that facilitate the onboarding process.
Cynthia L. Kryder, MS, CCC-Sp, Phoenixville, PA
F-25 | Soft Skills: What Are They, and Which Ones
F-21 | Oral Questioning Skills for Medical
Communicators A major factor in a medical communicator’s professional success is asking questions—the right questions. At this roundtable, participants will discuss and practice ways to hone their questioning skills in order to elicit the right information they need to do their job. This roundtable discussion is also offered on Thursday. Elizabeth G. Frick, PhD, ELS, The Text Doctor LLC, Boulder, CO
F-22 | Priority Management: Being a Professional
and a Parent Participants will discuss ways to achieve work-life balance by developing time-saving techniques and organization strategies and finding solutions that fit their family situation. Shanna J. McClennen, PhD, Needham, MA
F-23 | Scientific Congress Coverage for a
Pharmaceutical/Biotechnology Company Participants will discuss and learn how to obtain and report essential information from a flagship clinical congress and discuss insights for gathering information efficiently. This roundtable discussion is also offered on Thursday. Albert Y. Rhee, PhD, Amgen Inc., Thousand Oaks, CA
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Caryl L. Burke, MA, Medpace, Inc, Cincinnati, OH
Am I Missing? Technical proficiency isn’t enough; it needs to be accompanied by those nebulous “soft skills.” Participants will discuss answers to the questions “What are soft skills?” and “Do I have them?” Kelleen Flaherty, Biomedical Writing Programs, University of the Sciences, Philadelphia, PA
F-26 | Telecommuter Etiquette Participants will discuss best practices for telecommuting, with a focus on three themes: managing workflow, setting expectations, and building rapport. Robin Whitsell, BPh, Whitsell Innovations, Inc, Chapel Hill, NC
F-27 | Using Checklists for More Efficient Editing
This discussion will focus on industries that require the use of checklists and items that could appear on editing checklists. Participants will learn how to formulate their own checklists in order to avoid common errors and speed the editing process.This roundtable discussion is also offered on Thursday. Kelly A. Schrank, Med Communications, Canastota, NY
F-28 | Using Public Relations to Promote Medical Discoveries, Programs, and Services This discussion will focus on how to develop and execute a communication outreach plan from start to
P R AC TI C A L SKILLS
full program schedule | FRIday finish. The roundtable facilitator will share a sample project and experiences in developing an outreach campaign. Katrina R. Burton, BS, MD Anderson Cancer Center, Houston, TX
F-29 | Web Presence and Marketing: New Skill Set
for the Freelance Medical Writer Participants will discuss tips about website development in order to establish a web presence, and also how to use social media to effectively market their “brand.”
F-32 | Your Website Is Your Professional Image Participants will explore the advantages of creating a website as a marketing tool, a reflection of their professional image, an online portfolio, a repository of client recommendations, and more. Topics include purchasing and registering a domain name, choosing a web hosting service and content management system, building a website structure, finding images, and writing in “web-speak.” This roundtable discussion is also offered on Thursday.
Anita Misra-Press, PhD, Portland, OR
Jennifer G. Maybin, MA, ELS, Maybin Healthcare Communications, LLC, Branchburg, NJ
F-30 | What Really Is Networking? And How
12:15–1:45 PM
Seasoned Medical Writers Can Benefit from It Networking can enrich and stimulate your professional growth by helping to identify sources of collaboration, ways to work more efficiently, or connections that can benefit another contact. At this roundtable discussion, we will explore how to network effectively and how experienced writers can benefit from it. Tracy E. Bunting-Early, PhD, Bunting Medical Communications, Inc, Newark, DE
F-31 | Writing for MRL Review
Participants will discuss the different players in the medical-regulatory-legal (MRL) review, and find out how medical writers might be asked to interact with them. Get an inside look at what these MRL review boards call themselves, such as CAC, Copy Approval, PRB, PRC, MAC, MAP, Med/Legal, and RC, and what medical communication agencies go through to get their clients’ materials approved. Other topics include how to write scoping questions for deliverables requiring MRL review, predict MRL responses, and resolve conflicting comments. Sarah Zimov, PhD, Sarah Zimov PhD, LLC, BioMedical Communications, New Hope, PA
Chapter Resource Room Open Meet to discuss chapter issues with your chapter members or with other chapter leaders. You must reserve space at annual_conference@amwa.org to ensure that the room can accommodate your meeting.
2:00–3:00 PM OS-37 | Hands-on Demonstration: Building and
Growing Medical Writing Business Websites Using Open Source Content Management Systems (CMS) [Technology] Designed for medical writers with or without web design experience, this seminar will provide an overview of Open Source content management systems (CMS), including WordPress software, which is used by more than 16% of top business and university websites. Additionally, installation and use of Open Source document collaboration tools, such as WP Documents and EtherPad, that can be coupled with WordPress or other CMS tools will be demonstrated. When combined, these low-cost strategies allow multiple writers to collaborate and revise documents in a real-time browser-based environment, providing a graphically appealing web platform for medical writing that requires minimal programming and web design skill.
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full program schedule | FRIday Bring your WiFi-enabled laptop or handheld device and, optionally, web host information. Angela N. Johnson, BFA, MS, PMP, Medical Writer, Angie Biotech LLC and Web Instructor, Coastal Community College, Wilmington, NC
on constructing flow diagrams and then work in small groups to construct one from an existing narrative. This how-to seminar will be of most value for medical writers who work on grants, SOPs, or study protocols, regardless of level of experience.
OS-38 | Conceive and Create to Communicate:
Carol Lorenz, PhD, Principal, D&H Clinical Consulting, Hillsborough, NC
Designing Effective Slide Presentations [Other Skills] One key component to a successful presentation is having well-designed slides that support the topic of discussion. In this how-to seminar, you will learn about developing a presentation according to the seminar leaders’ four-step process: (1) Conceive: psychology of design (how the mind processes visual information) and what design principles to apply to cater to certain audiences; (2) Create: general rules regarding proper use of real estate, color, font style, font size, tables, graphs, animation/images, and references when creating presentation slides; (3) Apply: examples of effective and ineffective slide designs to engage audience participation; and (4) Question/Answer: how to handle this portion of the presentation effectively. Karen Blackburn, MS, Senior Medical Writer, inVentiv Health Clinical, Ann Arbor, MI Eileen Girten, MS, Senior Medical Writer, inVentiv Health Clinical, Blue Bell, PA
OS-39 | How to Construct Flow Diagrams [Other Skills] Much of the information in clinical research protocols (eg, clinical trials, research studies) and in standard operating procedures (SOPs) needs to be documented in a logical and linear format. Flow diagrams offer a technique for literally “drawing a picture” of the flow of the study or SOP which can then be used as an outline for the narrative. Alternatively, for studies or SOPs written in a narrative format, the flow diagram can be used as a way to test understanding of the narrative and identify areas that may be confusing so that the writer can seek clarity. You will receive basic instruction
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OS-40 | How to Network: A Systematic, Hands-on Approach [Professional Relationships] Networking is a skill that many of us struggle with. In this highly interactive how-to seminar, the leader will break down networking into a series of learnable steps (how to start a conversation, keep a conversation going, and end a conversation). Additional topics to be covered include how to approach online and social networking, low-pressure ways to practice networking, and tips for maintaining positive relationships with your contacts. Each step or topic will be introduced and discussed briefly. Then participants will practice the new skill. Finally, participants will provide feedback to each other. Through this process, networking will become less intimidating and more approachable. Kerri Hebard-Massey, PhD, Medical Writing Manager, Amgen Inc., Thousand Oaks, CA
OS-41 | Marketing Bingo! [Professional
Relationships] Most medical writers love their work but hate marketing themselves. This seminar explores 25 self-marketing tactics, from the simplest (have a business card) to the most complex (earn certification or awards in your field). Play BINGO: When you achieve Bingo, you will get a special, free gift. Taught by a successful veteran of 22 years in the freelance trenches, this practical seminar will help even the most marketing-averse medical writers look at marketing in a more productive way. Elizabeth G. Frick, PhD, ELS, President/CEO, The Text Doctor LLC, Boulder, CO
e d i t i ng
full program schedule | FRIday OS-42 | Optimizing Partnerships Between Pharma
and Med Comm for Scientific Publications [Professional Relationships] Optimizing the relationship between pharmaceutical clients and medical communication companies has become challenging. Apart from producing content for medical communications for authors under tight timelines and budgets, compliance and other legal/ regulatory obligations have become much stricter, particularly for companies under corporate integrity agreements (CIAs). Learn about the challenges of both groups and how to work ethically together to meet scientific and business goals while remaining in compliance with numerous guidelines including GCP, ICMJE, company SOPs, and CIA publication requirements where applicable. John Smith, PhD, CMPP, Senior Manager, Novo Nordisk, Inc., Princeton, NJ Sheba Mathew, PhD, Associate Director, Novo Nordisk, Inc., Princeton, NJ
OS-43 | Successful “Onboarding”: Filling the Gap Between Orientation and Integration [Regulatory] New employees often receive a brief company orientation and a list of standard operating procedures to read. Then they are expected to get right to work. They often feel unsure of what to do and how to do it; this can result in delays before work of the required quality is produced. That gap can be bridged with appropriate “onboarding.” This seminar will provide examples of successful onboarding programs and suggestions for how to create a similar program. Joanne Rosenberg, MS, ELS, Senior Manager, Global Medical Writing, Allergan, Inc., Bridgewater, NJ
OS-44 | Use a SWOT Analysis to Rejuvenate Your
Freelance Career and Better Market Your Business [Freelance] Whether novice or pro, freelances frequently wonder whether their medical communication careers are
headed in the right direction. In this how-to seminar, two seasoned freelances with more than 40 years of collective experience will show you how to use a simple tool—the SWOT analysis—to refocus or redirect and rejuvenate your freelance business and better market yourself. You will have the opportunity to complete exercises to help you identify your business’ strengths, weaknesses, opportunities, and threats (SWOT), and you will learn marketing strategies and tactics to consider based on your results. Cyndy L. Kryder, MS, CCC-Sp, Medical Communications Specialist, Phoenixville, PA Brian R. Bass, President, Bass Global, Inc., Robbinsville, NJ
2:00–5:00 PM WS-45 | Advanced Data Presentation: Tables,
Graphs, and Charts (ADV) [701] This course will emphasize group participation in exploring the solutions to graphic problems submitted by participants. Other means of portraying information, such as flow charts and box and whisker plots, will be discussed. APPROXIMATE HOMEWORK TIME: 3 HOURS. Bart Harvey, MD, PhD, University of Toronto, Toronto, ON
WS-46 | Advanced Writing (ADV) [706]
Experienced biomedical writers will explore ways in which they can become even better. Participants will discuss the cognitive processes used by writers and a few finer points of style, and they will learn some successful strategies for approaching (and completing) a writing project. For the precourse assignment, participants will begin to analyze the process used in their writing and the effect of writer’s block on that process. Recommended: 5 years’ experience in editing or writing. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Marianne Mallia, ELS, Manager and Senior Medical Writer, Scientific Publications, Texas Heart Institute, Houston, TX
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full program schedule | FRIday WS-47 | Effective Paragraphing (ES/G) [2003]
This lecture and discussion workshop provides novices and moderately experienced writers and editors with some basic paragraphing techniques for achieving clarity, readability, and desired emphasis. The objective is development of a systematic approach to analyzing and revising text. Options for arranging paragraphs and using transitions will be demonstrated and applied in this review course. APPROXIMATE HOMEWORK TIME: 4 HOURS. Same as WS-2.
Helen E. Hodgson, PhD, Professor of Communication, Westminster College, Salt Lake City, UT
WS-48 | Outlining for Writers and Editors (ES/EW/FL) [2007] This workshop is designed for intermediate-level writers and editors. Participants will learn to use outlining for writing and editing medical texts. Topics will include the “what, why, and how” of formal outlining and its usefulness in gaining consensus on planned content, overcoming mental blocks, and reorganizing drafts. APPROXIMATE HOMEWORK TIME: 2–3 HOURS. Same as WS-11.
Sue Hudson, Senior Medical Writer, Medical Writing Associates, Simi Valley, CA Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Marfa, TX and Nashville, TN
WS-49 | Tables and Graphs (ES/G) [2011]
The workshop leader will cover definitions and uses of tables and graphs, as well as guidelines for preparing and editing them. The focus of the workshop, designed for the beginner, is the preparation of tables and graphs that are usable, that communicate, and that are appropriate for the situation. Participation is encouraged as we evaluate problematic tables and graphs. APPROXIMATE HOMEWORK TIME: 3–4 HOURS. Same as WS-1.
Mark D. Weiss, MA, MS, President, Apothaceutics International, Inc., Congers, NY
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WS-50 | Introduction to the Medical Device Industry
(B/PH) [2503] The workshop leaders will cover the medical device industry, opportunities for medical writers in the industry, and the US and global regulatory environments that govern medical devices. Topics will also include the major market segments; products and therapeutic indications; specific job opportunities in the regulatory, clinical, and marketing departments; and the types of projects that may be assigned to employees or vendors. The workshop is designed for anyone with an interest in medical devices. The goal is to provide the participant with an overview of the industry, job and freelance opportunities in medical device companies, and a streamlined version of the regulatory environments in which these companies function. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Jim Hudson, Partner, Medical Writing Associates, Simi Valley, CA
Scott C. Thompson, ELS, Principal Medical Writer, Medtronic Spinal Business, Memphis, TN
WS-51 | Writing and Copyediting the Multimedia
Project (CP/EW/FL) [3020] For writers who are new to multimedia projects, this case-study presentation will incorporate lecture and group discussion to outline the steps in developing a computer-based multimedia training program. The main focus will be writing and editing for the screen—not programming! Storyboards, vendors, and troubleshooting will be discussed. APPROXIMATE HOMEWORK TIME: 2 HOURS.
Jim Cozzarin, ELS, Senior Editor, ProEd Communications, Beachwood, OH Nick Sidorovich, MSEd, President, Rolling Hill Media, LLC, Chatham, NJ
ca r e e r d e v e l o pm e n t
full program schedule | FRIday WS-52 | Medical Journalism: From Choosing a Topic Through Polishing the Piece (CP/EW/FL) [3009] Intended mainly for newcomers to medical journalism, this workshop will explore through presentation and discussion the basics of writing articles on medical topics for magazines, newspapers, and other publications for general readers. Aspects to be addressed will include choosing topics, gathering and evaluating information, and crafting and refining the piece. APPROXIMATE HOMEWORK TIME: 3–4 HOURS.
Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX
WS-53 | Writing and Editing NIH Grants (CP/EW/FL)
[3022] This lecture and group discussion will provide a thorough framework for both new and experienced medical editors to make the grant-preparation process less harried. NIH applications are the topic of this workshop. Writing and editing exercises to craft key portions of an application will be included. Private (eg, foundation) proposals will not be addressed in this workshop. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Karen Potvin Klein, MA, ELS, Associate Director, Office of Research, Wake Forest University Health Sciences, WinstonSalem, NC Kristina Wasson-Blader, PhD, ELS, Science Editor, University of Oklahoma Health Sciences Center, Oklahoma City, OK
WS-54 | Writing and Designing Materials for Patient
Education (CP/EW/PRAM) [3021] Through lecture and discussion, writers with little or no experience in writing for patients will work through the “what, who, and how” of a patient-education piece: planning, research, writing, design, production, and evaluation. Participants will critique sample booklets and review the homework. APPROXIMATE HOMEWORK TIME: 2–3 HOURS. Sharon Nancekivell, MA, Freelance, Guelph, ON
Carol Diberardino, MLA, ELS, Lindenwold, NJ
WS-55 | Ethical Standards in Medical Publication
(CP/EW/PH) [3004] This workshop is required for individuals working to earn the Composition and Publication specialty certificate. In this workshop, intended for novices and moderately experienced writers and editors, the leader will examine ethical issues in scientific publication. Participants will discuss essential publication guidelines and existing ethical standards while highlighting controversial and unresolved issues. Authors’ editors, journal editors, and writers who participate in the creation of manuscripts often have conflicting perspectives on authorship, duplicate publication, conflict of interest, and peer review; these perspectives will be examined. APPROXIMATE HOMEWORK TIME: 3 HOURS. Nancy D. Taylor, PhD, ELS, Greenville, SC
Andrea R. Gwosdow, PhD, President, Gwosdow Associates Science Consultants, LLC, Arlington, MA
WS-56 | Ethics in Communicating Science and
Medicine (SM) [3524] This workshop is required for individuals working to earn the Concepts in Science and Medicine specialty certificate. This workshop provides an overview of ethical considerations for communicating medicine and science to patients, health care providers, and others. Research-and-regulatory issues and publication-related issues will not be addressed because they are the focus of other workshops. This workshop comprises a homework assignment, an interactive lecture, and a class exercise. Participants will be divided into small groups, each of which will be given one of the case studies submitted as part of the homework. Groups will be asked to name the ethical situation, identify the stakeholders and their perspectives, debate potential decisions, and present their results to the entire group through role-play. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Tami Ball, MD, inVentiv Health Clinical, Asheville, NC Kathy Spiegel, PhD, Amgen Inc., Grass Lake, MI
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full program schedule | FRIday WS-57 | Introduction to Basic Virology (SM) [3510]
This workshop is intended for medical writers and editors who want to improve their understanding of basic principles around the morphology, replication, and transmission of viruses. Previous background or some coursework in basic cell biology or molecular biology will be useful. The workshop leaders will review basic virus classifications, as well as several representative viruses that relate to clinical disease states, then focus on diagnostic tests used to identify viruses; antiviral therapies (vaccines vs antiviral medications); and mechanisms of viral resistance. Additional topics will include basic virus-host interactions, including key immune responses, principles around immune evasion, and oncogenic viruses in people. This workshop is appropriate for those who write for the public as well as those who write for medical and scientific readers. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Thomas Gegeny, MS, ELS, Envision Scientific Solutions, Southport, CT Rebecca Jarvis Beck, PhD, CMPP, Envision Scientific Solutions, Southport, CT
WS-58 | Basic Cell Biology (SM/EW/PH/SG) [3500]
Curious about the basic building blocks of life? Wish to learn more about DNA? And just what are those mitochondria everyone is talking about? The presentation will cover the basics of cell biology and prepare you for more advanced and specialized classes. Watch out! If we have time, we will dance like chromosomes! APPROXIMATE HOMEWORK TIME: 1–2 HOURS.
MaryAnn Foote, PhD, MA Foote Associates, Westlake Village, CA
WS-59 | Summarizing Clinical Efficacy Data for an NDA (RR) [4013] This workshop is appropriate for regulatory/medical communicators who are moderately experienced in writing clinical regulatory documents. The teaching
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style will be primarily lecture with an exercise and some opportunity for discussion. The workshop leader will focus on what regulatory/medical communicators need to know to effectively write the high-level clinical efficacy documents required specifically by the Food and Drug Administration for US New Drug Applications (NDAs), namely the Module 5.3.5.3 Report of Integrated Efficacy Analysis (ISE) vs the Module 2.7.3 Summary of Clinical Efficacy. Associated regulations and guidelines will be discussed, as well as the source documents and other tools needed for generating these documents. APPROXIMATE HOMEWORK TIME: 2–3 HOURS. Marijke Adams, PharmD, PhD, President, MH Adams & Associates, Inc., Davie, FL
WS-60 | Clinical Study Report Writing: From Tables,
Listings, and Graphs to Text (RR) [4019] This workshop is intended for writers and editors in clinical research with basic to moderate experience in developing clinical study reports (CSRs). With a focus on practical guidelines and examples, the workshop will give you a sense of how best to summarize information from statistical tables, listings, and graphs (TLGs) for a CSR. Examples will include selected passages from the demographics, and the efficacy and safety sections of a CSR, along with the related TLGs to clearly demonstrate the link between text and TLGs. Emphasis will be on presenting data in a clear and concise manner. Many participants may benefit from first taking the Writing the Final Report of a Clinical Trial workshop. APPROXIMATE HOMEWORK TIME: 4 HOURS.
Lawrence Giraudi, MSc, Manager, Regulatory Documentation, Hoffmann-La Roche, Toronto, ON
WS-61 | Reporting Correlation and Regression
Analyses (RR/G/SG) [4011] This workshop approaches the topics of correlation and linear regression analysis conceptually, not mathematically, so you will not learn to run a regression analysis,
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full program schedule | FRIday but you will learn to interpret and report the results. This workshop is suitable for new and experienced medical writers and editors, but it is recommended to take the Statistics for Medical Writers and Editors workshop beforehand or have the equivalent knowledge. APPROXIMATE HOMEWORK TIME: 3 HOURS. Jane Neff Rollins, MSPH, Arnell Communications, Montrose, CA
WS-62 | Writing the Final Report of a Clinical Trial
(RR/PH) [4016] This workshop is intended for novices and moderately experienced medical writers; the leaders will offer approaches to generating a clinical study report. The components of the report, issues of quality control, and common problems and situations will be reviewed. Within this framework, ideal and real-world experiences will be discussed. The impact of guidelines from the International Conference on Harmonisation (ICH) and their effect on the standard report structure will be discussed in detail. APPROXIMATE HOMEWORK TIME: 4 HOURS. Same as WS-6.
Howard M. Smith, MA, Consultant Medical Editor, Sandy Hook, VA
WS-63 | Learning in the Health Professions:
Practical Strategies for Developing Continuing Education Cases (Non-credit) Lifelong learning in the healthcare professions through continuing education/professional development (CE/ CPD) offers a potential growth area for medical writers. This foundational workshop will enable you to prepare case-based education materials for CE/CPD activities. Through group-based activities and discussion, we will review how adult learning principles support case-based CE/CPD, examine features that enhance the effectiveness of cases, and practice strategies for developing case-based CE/CPD activities to optimize learning.
Alexandra Howson, PhD, CCMEP, Owner, Thistle Editorial LLC, Snoqualmie, WA
3:30–4:30 PM OS-45 | Acing Your Ad Boards: How to Develop Ad
Board Content that Wins Clients Over Every Time [Writing/Editing] Advisory board meetings are important tools used by clients to gather valuable information from individuals whose expertise they respect. These meetings can fulfill a variety of purposes, including helping clients gather knowledge around a key topic area for the purpose of creating articles or white papers, providing direction on future pharmaceutical drug development and marketing strategies, and developing consensus on preliminary data from large clinical trials. This seminar will illustrate indispensable strategies for creating winning advisory board meeting materials. You will learn tips for developing engaging discussion guides, creating slides that get the attention of meeting participants, and writing final reports that fulfill clients’ primary objectives. This seminar will offer tools that can be used for web-ad boards, investigator meetings, focus groups, and traditional advisory board/roundtable formats. Alita Anderson, MD, Principal, Eubio Medical Communications, Atlanta, GA
OS-46 | Hands-on Demonstration: Beyond Index
Cards: Using Scrivener and Zotero [Other Skills] Suffering from information overload? In a big, complex story, keeping track of the fine details, facts, and citations can be enormously difficult and a huge time sink. This seminar will focus on two tools to make both writing and fact-checking easier: Scrivener and Zotero. The leader will present a case study to describe how she used these tools in organizing and writing a complicated story for the Scientific American series, in which she dissected the death of a clinical trial participant at the University of Minnesota (Markingson case). You will be encouraged to share your tricks and tools for gathering research and organizing your writing. Bring your WiFi-enabled laptop to follow along as the seminar
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full program schedule | FRIday leader illustrates the elements of the process and to gain experience with the tools. Judy Stone, MD, Blogger, Scientific American blog network, Cumberland, MD
OS-47 | Cultivating Your Ecosystem to Build Your
Business and Brand [Freelance] All the business cards and LinkedIn contacts in the world can’t guarantee you a robust stream of work. This interactive how-to seminar will highlight how, by taking an “ecosystem” approach to your network, you can improve the chances that your contacts will refer business to you. Ecosystems are an invaluable resource for lead generation and are crucial to marketing. Since they’re based on building relationships, they don’t require the overt promotion that many writers and editors dread. Two experienced freelances will discuss the different ways they think about, categorize, and cultivate their ecosystems. Learn proven techniques for finding and assessing potential additions. Consider the benefits of ecosystems in terms of referrals, resources, and branding. Get tips for how to develop relationships without being seen as a pest. Build and leverage a thriving ecosystem that markets your business for you! Christine Welniak, Principal, Upside Communications, Brooklyn, NY Jeanne McAdara-Berkowitz, PhD, Principal, Biolexica Health Science Communications, Longmont, CO
OS-48 | Where Does the Sun Shine? The Regulatory
Environment, Education, and Promotions [Continuing Education for Health Professionals] This seminar will provide a survey of the overall regulatory environment and a review of the “Sunshine Act” final rules, changes in state laws, and trends in institutional regulations. All of these can affect medical writers, their employers, and their professional colleagues by limiting opportunities, requiring reporting of payments, or leading to contradictions or conflicts.
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Do’s and don’ts for medical writers who provide services for both continuing medical education (CME) and non-CME projects will define the difference between CME and promotional medical writing and show how to avoid conflicts between CME and non-CME medical writing. Pam Ostreicher, PhD, Scientific Writer, ONS: Edge, Pittsburgh, PA
Marissa Seligman, PharmD, Senior Vice President, pmiCME, Boston, MA
3:30–5:00 PM OS-49 | Encore Presentations from the Drug
Information Association Medical and Scientific Communications Annual Forum “Digital Channel Use in Scientific Communications” [Technology] Social media and the use of smartphones and tablets have revolutionized how we interact, communicate, and access information. Breaking news is no longer saved for the nightly news on your local television station; news is communicated real time through social media platforms and applications such as Twitter, YouTube, and Facebook. Likewise, our communication model for the release of scientific information must also evolve. Learn about the changes facing medical communicators in the channels for delivering scientific communications. Jennifer Riggins, PharmD, Advisor, Digital Channels and eCapabilities, Customer Experience and Medical Affairs, Eli Lilly and Company, Indianapolis, IN
“Graphical Presentation for Publications: Anatomy of a Figure” [Other Skills] Figures are an important component of clinical trial publications. If a picture is worth a thousand words, then authors and medical writers should ensure that figures effectively display clinical trial results. This presentation will provide an overview of common types of
r e g u l at o ry w r i t i ng
full program schedule | FRIday figures (flow diagrams, Kaplan-Meier plots, forest plots, repeated-measures plots, etc) and a review of guidelines for style and content. Participants will be invited to critique “good” and “bad” examples. Ultimately, the goal of this presentation is to promote the use of welldesigned, easily interpretable graphs in clinical trial publications Ann Winter-Vann, PhD, Medical Writer and Consultant, Whitsell Innovations, Chapel Hill, NC
OS-50 | Medical Writer IT Tools and Techniques— Work Better and Faster [Technology] This panel presentation will focus on technology tools, such as macros, automation, toolbars, and formatting software, that can be used to help overcome complexities in medical writing in an era of quick turnaround times. Learn how to harness technology and strategic process to drive unprecedented innovation and gain competitive advantage. Panel members will provide information on how to manage your own IT processes on computers (including mobile devices and cell phones). Today, secure and efficient data transfer and storage is mandatory. Learn about good IT practices, such as backups, updates, and social media practices, as well as cool gadgets to keep computing devices humming smoothly.
and navigate successfully complex systems for prevention, health care, emergency preparedness and safety. A panel of experts will provide strategies and examples to promote health literacy for diverse populations and develop a health literate culture in organizations; will discuss numeracy and how it affects understanding of risks and health decisions; and will address the need for cultural competency in communicating effectively within different racial/ethnic populations. Moderator: Lori Alexander, MTPW, ELS, President, Editorial Rx, Inc., Orange Park, FL Cynthia Baur, PhD, Senior Advisor, Health Literacy, Centers for Disease Control and Prevention, Atlanta, GA Ellen Peters, PhD, Professor of Psychology and Senior Fellow in the Center for Personalized Health Care, The Ohio State University, Columbus, OH Charleta Tavares, Executive Director, Multiethnic Advocates for Cultural Competence, Columbus, OH
OS-52 | What Employers Are Interested in: How to
Pralhad N. Dhagale, M.Pharm., Manager-Medical Writing, SIRO Clinpharm, Pvt. Ltd., Mumbai, India
Progress Your Career [Career Development] This interactive panel discussion will provide different viewpoints and advice from hiring managers, recruiters, and employees of pharmaceutical companies, clinical research organizations, medical communication agencies, and other settings. Among the topics addressed are how to enter the field, tips on how to structure a resume, common interview questions, career ladders, the importance of attitude, and what makes an “attractive” candidate for medical writing.
Vatsal Shah, MBBS, MD, Vice President & Global Head, Medical Writing & Pharmacovigilance, SIRO Clinpharm, Pvt. Ltd.
Moderator (and speaker): Dandan Zhu, Head of Regulatory Writing Recruitment, Real Staffing Group, New York, NY
OS-51 | Strategies for Communicating with Diverse
Dennis Bren, MA, Associate Director, Regulatory and Medical Affairs, Medpace, Cincinnati, OH
Moderator (and speaker): Susan Bairnsfather, CEO, EPharmaTech LLC, Shreveport, LA
Audiences: Words, Numbers, and Ideas about Health [Writing/Editing] Health literacy is a fundamental skill set for people and organizations. People must be health literate to find
Carol Bader, MS, RAC, Principal Medical Writer, UCB Biosciences, Inc., Raleigh, NC
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ETHICS
full program schedule | SATURday 7:00–9:00 PM
AMWA SABLACK AWARDS DINNER (ticketed event, with additional fee; cash bar opens at 6:30 PM) This is the premier event at every AMWA Annual Conference, attended by the who’s who of conference attendees and AMWA members. Named after AMWA’s first executive director, Lillian Sablack, the dinner is an event to recognize outstanding service and contributions by medical communicators. Presentation of the President’s Award: 2012-2013 AMWA President, Douglas Haneline, PhD, will present the award. The President’s Award is given to a person who has been a member of AMWA for at least 10 years; has made distinctive contributions to the association at the chapter level, the national level, or both; and has not served on the executive committee. Presentation of the Golden Apple Award: Faith Reidenbach, ELS, chair of the 2013 Golden Apple Award Committee, will present this award for excellence in workshop leadership to Lanie M. Adamson, MS. 2013 Student Scholarship: Alyssa Wu-Zhang, PhD, chair of the 2013 Student Scholarship Committee, will announce the winner of the 2013 AMWA Annual Conference Student Scholarship. Presentation of the Eric W. Martin Awards: 20122013 Awards Administrator, Deborah Whippen, will present the Eric W. Martin Awards for Excellence in Medical Writing to Eleanor Mayfield, ELS, and Jane N. Buchwald, MA. These awards are given annually to AMWA members for articles published during the preceding calendar year. Presentation of the AMWA Medical Book Awards: Awards for excellence in the following categories: books for physicians, books for health care professionals–nonphysicians, and books for the public or health care consumers.
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Presentation of 2013 Fellowships: 2013 Fellowship Committee chair, Melanie Fridl Ross, MSJ, ELS, will present Fellowship Awards to Jennifer Grodberg, PhD, RAC, Jude Richard, ELS, and Anne Marie Weber-Main, PhD, for significant contributions to the goals and activities of the association. Presentation of the Harold Swanberg Distinguished Service Award and Swanberg Address: Barbara R. Snyder, MA, 2013 Swanberg Committee chair, will present the Swanberg Distinguished Service Award, given for distinguished contributions to medical communication and the medical profession, to Cindy Hamilton, PharmD, ELS, who will then present her award address.
Saturday, November 9 7:00 AM–3:00 PM
CONFERENCE REGISTRATION AND AMWA INFORMATION DESK OPEN
9:00–10:15 AM
GENERAL SESSION AND MCGOVERN AWARD ADDRESS Introduction of the McGovern Award Recipient: The John P. McGovern Medal is given to a person known for preeminent contributions to medical communication. Recipient: Cynthia Baur, PhD, Senior Advisor, Health Literacy, Centers for Disease Control and Prevention, Atlanta, GA McGovern Award Address: The Imperative for Public Understanding of Health, Medical, and Scientific Information Health, medical, and scientific topics are daily news and conversational items, especially in the age of social media. Advice in popular magazines about diet and exercise, news coverage of court cases about genetics, local zoning board discussions about air quality or pedestrian safety, school policies about health education in the classroom, and tabloid coverage of the
MEDICAL ILLUSTRATION
full program schedule | Saturday latest celebrity’s addictions – all are part of the court of public opinion and commentary. But, research shows that deep public understanding of health, medical, and scientific topics is often lacking. We must find ways to engage the public on these topics and build their health and science literacy. Professional communicators bear a special responsibility for this task. It is time to re-double our efforts to be clear, complete, and accurate in our information presentation and help create a truly engaged, informed citizenry.
10:30–11:30 AM OS-53 | $53 Billion and Counting: The Global War
against HIV/AIDS, Tuberculosis, and Malaria [Health and Medicine] In the late 1990s, epidemiologists sounded an alarm with predictions that HIV/AIDS, tuberculosis, and malaria would wipe out millions of people within a decade. The world’s response to averting this catastrophe was hatched in 2002 and 2003, when, respectively, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the President’s Emergency Plan for AIDS Relief (PEPFAR) came into being. Participants will learn how these organizations have affected global health in the past decade, how funding and programmatic decisions are made, and what the future might bring. Terry Anderson, Writer/Editor, Alan Edits LLC, Silver Spring, MD
OS-54 | Cognitive Science + Common Sense =
Effective Presentations [Other Skills] Applying a unique blend of cognitive science and common sense, the leader of this seminar takes you on a journey that can improve every presentation you deliver, ultimately enhancing your ability to inform, influence, and persuade others. You will learn (1) the importance of separating the spoken word from the written word to improve communication; (2) the value of applying universal principles of face-to-face
communication to all communication challenges, not just presentations; and (3) the significance of answering questions clearly, concisely, and effectively. Eric Bergman, ABC, APR, MC, Author, 5 Steps to Conquer ‘Death by PowerPoint,’ Pickering, ON
OS-55 | Effective Social Media Strategies for Health
Communicators [Public Relations/Marketing] Successful social media strategies powerfully engage patients and community, reinforce and promote a brand, and build advocacy. So why aren’t more medical communicators using social media? Are hospitals concerned about patients’ privacy and confidentiality issues? Do communicators working in PR or publications need an understanding of best practices? This seminar will provide an overview of the most popular social media outlets, such as LinkedIn, Twitter, YouTube, Google+, and Facebook, in addition to blogging. No matter what area of medical and health communication you work in, you will learn how to decide which outlet is best to achieve your goals and how to effectively incorporate them into an overall marketing strategy. HIPAA patient privacy laws, social media policies, and other potential legal ramifications that must be considered when producing content for patients through these various social media outlets will also be discussed. Felicia L. Hudson, BA, Writer and Communications Consultant, Hudson Creative Copy, Chicago, IL Brande N. Martin, MA, Content Manager, College of American Pathologists, Northfield, IL
OS-56 | Evolving Medical Publications
CANCELED Guidelines: Ethics, Integrity, and the T-Word [Journal Management] The three most important factors in medical publications are transparency, transparency, transparency. Scrutiny of the medical publications industry is increasing, with intense focus on transparency in terms of
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CAREER DEVELOPMENT
full program schedule | Saturday declaration of participation, disclosure of financial relationships, and acknowledgment of significant contributions in order to ensure the scientific integrity of the publication. It often falls on the medical writer to ensure that authors and other stakeholders are adhering to the applicable guidelines, which are ever-evolving and subject to interpretation. From ICMJE to GPP2 and even the Sunshine Act, this seminar will address guidelines related to authorship and contributorship, industry recommendations for manuscript submission, and the evolving role of the medical writer. Ann L. Davis, MPH, CMPP, Senior Medical Communication Scientist, Bristol-Myers Squibb, Conshohocken, PA
OS-57 | Stating Your Case (Study) [Continuing
Education for Health Professionals] Case-based learning is the new normal in adult education. Harvard’s MBA program, for one, recently shifted its entire curriculum to a case-based format. This trend is also seen in health care education, as both promotional and accredited education shifts from traditional didactic approaches to more interactive, patient case-based formats. In this seminar, you will learn the nuts and bolts of creating robust case studies, including why it is important to include enough, but not too much, information within a case. The seminar leaders will also devote time to the art of developing appropriate knowledge- and competence-based questions within case studies that require learner interpretation and enhance learner interaction. Scott Kober, MBA, CCMEP; Institute for Continuing Healthcare Education, Philadelphia, PA Eve J. Wilson, PhD, ELS, Independent Writer/Editor, MORPHOS Medical Education, LLC; Bowie, MD
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OS-58 | Teaming is a Verb: The Mindset and Practices of Effective Teamwork [Professional Relationships] A highly successful CEO of a large corporation once said, “If you could get all the people in an organization rowing in the same direction, you could dominate any industry, in any market, against any competition, at any time.” Teamwork is not just about understanding the roles and responsibilities of each member of the team, it’s about exhibiting key teaming behaviors that translate across boundaries and ever-changing team structures. The goals of this seminar are to share five key characteristics of high-performing teams, and to facilitate large- and small-group discussions in which participants will describe personal milestone behaviors that exemplify effective teaming in their work environment. You will have the opportunity to develop a plan to focus on and strengthen a key personal teaming behavior. Janice M. Sabatine, PhD, CSC, President, Avanti Strategies, LLC, Cranberry Township, PA
10:30 AM–12:00 PM OS-59 | Communicating Health Messages: From
Narrative to Emotional Appeals to Visuals [Writing/ Editing] Reaching lay audiences with health information is a challenge. Panel members will discuss three different strategies for creating effective health messages: narrative, graphics, and emotional appeals. Participants will learn how narrative—telling a story—in health care communication can increase health literacy and understanding. Research on the use of emotion in health promotion messages will also be discussed, with an overview of how message recipients process and respond to various types of emotional appeals and illustration of how to use emotional appeals effectively in health messages. Evidence-based examples of symbol systems, decision support aids, and instructional interventions will also be presented, to demonstrate the impact of designed communications that integrate
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full program schedule | Saturday people, processes, words, and images. Moderator (and speaker): Lora Arduser, PhD, Assistant Professor, University of Cincinnati, Cincinnati, OH Catherine Goodall, PhD, Assistant Professor, School of Communication Studies, Kent State University, Kent, OH Mike Zender, MFA, Professor, Director of Graduate Program in Design, University of Cincinnati, Cincinnati, OH
OS-60 | New Safety and Risk-Benefit Reporting
Guidance and a Potential Strategy to Manage the Increased Workload [Regulatory] Pharmaceutical companies must submit reports on the clinical development of an investigational drug, as well as provide benefit-risk evaluation reporting on marketed products to the relevant regulatory authorities. Historically, the content, format, and timing of these reports varied by country and region. In 2010, the ICH approved a new guidance (E2F) for the Development Safety Update Report (DSUR), which is now requested by the European Union, United States, and Japanese regulatory authorities. In 2013, the International Conference on Harmonisation (ICH) guidance (E2C) introduced benefit-risk assessment (Periodic BenefitRisk Evaluation Report; PBRER). The panel will provide an overview of the development of DSUR and PBRER and provide insight into their modular elements. In addition, you will learn strategies to streamline the preparation of multiple, country-specific Chemistry, Manufacturing and Control (CMC) dossier sections and eliminate the need for multiple cycles of document preparation. Moderator (and speaker): Jennifer T. Bridgers, MS, Manager, Medical Writing, INC Research, LLC, Raleigh, NC Paula Fischthal, MA, Senior Medical Writer II, MedImmune, Gaithersburg, MD R. S. Robin Robinett, PhD, Director, BioProcess CMC, Merck & Co., West Point, PA
OS-61 | Scope of Medical Communication [Career Development] This panel presentation is designed for those who want to learn about the wide range of settings for medical writers. The panel includes medical writers and editors with decades of experience in their specialty or setting, including medical communication agencies, pharmaceutical and medical device industries, manuscript editing, public relations, and writing for lay audiences. The freelance aspect of each of these settings will also be discussed. Learn about the opportunities in these different settings; the knowledge, skills, and attitudes that best prepare you for each; how to break in—and advance; and what you can expect to earn. You will have ample time for questions and answers. Moderator (and speaker): Charlotte A. Kenreigh, PharmD, CMPP, Medical Writer, UBC-Envision Pharma Group, Southport, CT Linda Wagner, PharmD, Medical Writer, UBC-Envision Pharma Group, Southport, CT Jenny Grodberg, PhD, RAC, Senior Director, Regulatory Affairs, Trius Therapeutics, Inc., Carlsbad, CA Scott C. Thompson, ELS, Principal Medical Writer, Medtronic Spinal Business, Memphis, TN Marianne Mallia. ELS, Manager, Scientific Publications, Texas Heart Institute, Houston, TX Melanie Fridl Ross, MSJ, ELS, Chief Communications Officer, University of Florida Health, Gainesville, FL Additional speaker to be determined
OS-62 | When “Busy” Becomes “Overwhelmed”:
Tips for Avoiding—and Surviving—Burnout [“Soft Topics”] All professionals burn the proverbial candle at both ends once in awhile, but when we lose the will to say “no” to new work, regularly taking on more than we can handle, we run the risk of doing lasting damage to
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full program schedule | Saturday our personal and professional health. In this seminar, you will hear frank talk about the physical, psychologic, and professional risks of taking on too much work. Two busy and experienced freelances will discuss the patterns that lead medical writers to accept unhealthy workloads, the potential negative consequences to one’s health and professional well-being, strategies for avoiding burnout—or managing and recovering from it—and even the silver lining to be found in experiencing a burnout cycle. You will also hear from a professional expert in burnout, who will highlight the signs of burnout and opportunities to prevent it. Plus, you will hear about one option for avoiding (or recovering from) burnout: a sabbatical. Moderator (and speaker): Debra Gordon, MS, President, GordonSquared, Inc, Williamsburg, VA Additional speakers to be determined
10:45 AM–12:00 PM
Chapter Resource Room Open Meet to discuss chapter issues with your chapter members or with other chapter leaders. You must reserve space at annual_conference@amwa.org to ensure that the room can accommodate your meeting.
12:15–1:30 PM
AMWA ANNUAL BUSINESS MEETING LUNCH AND 2014 AMWA Annual Conference Kick-off Celebration with Prize Drawings (free ticketed event for AMWA members, advance registration required) Join us to get an update on AMWA from 2012-2013 President, Douglas Haneline, PhD, and Treasurer, Christine Wogan, MS, ELS, and witness the passing of the gavel to Brian Bass, the 2013-2014 President. We will also celebrate the site of AMWA’s 2014 Annual Conference: Memphis, TN.
2:00–3:00 PM OS-63 | Achieving Career Satisfaction: Working with a Professional Coach [Career Development] How often do you take the time to think, evaluate, plan, and take focused action to pursue your career and life satisfaction? In this seminar, you will learn how working with a professionally trained coach can help you do just that. You will discover how coaching differs from mentoring and how the benefit of using both in combination is more powerful than either alone. Also discussed will be how to find a coach and what to look for in a coach. You will complete a short exercise you can use when working with a coach.
Janice Sabatine, PhD, CSC, President, Avanti Strategies, Cranberry Township, PA
OS-64 | Advanced Microsoft Word 2010 for Windows
[Technology] Microsoft Word is ubiquitous in the publishing industry, medical or otherwise. Yet, many medical writers and editors use the program as little more than a glorified typewriter. In this seminar, you will learn how to make the program more useful—through preferences, macros, keyboard shortcuts, and styles—to create consistent, readable documents. Bring your laptop with Windows and MS Word 2010 already installed, as well as examples of both your frustrations and best practices. (You can even bring a challenging document to work on during the seminar.) Through this combination of instruction, hands-on tutorial, and “test driving,” you will learn how to get the most out of MS Word to expedite your workflow and create impeccable documents. For participants who have used MS Word 2007 or 2010 for at least 2 years; no beginners, please. Hope Lafferty, AM, ELS, Chief Medical Writer and Editor, Hope Lafferty Communications, Marfa, TX, and Nashville, TN Melissa Bogen, ELS, Owner, Bogen Editorial Services, Chester, NY
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full program schedule | Saturday OS-65 | A Slippery Slope into Project Management:
Beginner Skills and Terms [Other Skills] From launching a website to planning a conference to organizing a garage sale, project management techniques can help you achieve professional and personal goals on time and on budget. The leader of this seminar will discuss her slippery slope from medical communications into project management and the basic skills she needed for that transition. Learn what project management is, what it is not, and the basic steps, as taught by Franklin Covey and the Project Management Institute®. The leader will walk you through the overarching steps of managing a project; come with an idea for a project of your own to see how it is best broken down into steps. Lastly, because project management is needed in almost every industry, you will learn how to highlight and build existing project management skills in your resume (even if you didn’t think you had any!), such as the potential value and requirements of two particular certifications from the Project Management Institute (CAPM® and PMP®). Keightley Amen, ELS, Project Manager, ONS:Edge, Pittsburgh, PA
OS-66 | Spending Money Wisely to Increase Your Freelance Business [Freelance] It’s true: You have to spend money to make money. For freelances, the key is to allocate spending in areas that are most likely to provide a return on the investment. The differences between revenue-generating activities and “regular” operating expenses will be discussed. Participants will have the opportunity for hands-on experience with worksheets to estimate their typical spending on revenue-producing areas and evaluate what their targeted level of spending should be. The discussion will also focus on ways medical writers can market themselves and which strategies are more likely worth the financial investment. Participants will create a 2014 revenue-generating investment plan for their freelance business.
Christine Welniak, Principal, Upside Communications, Brooklyn, NY Melissa Wanner, PharmD, Geneva MedCom, Edgewater, MD
OS-67 | Sweats versus Suits: Is Telecommuting
Right for You? [“Soft Topics”] In this interactive pro/con debate, two speakers will discuss the advantages and disadvantages of telecommuting, the physical and psychologic aspects to consider (eg, ergonomics/work environment, dealing with isolation, personality traits of those who telecommute), and provide perspectives from an employer, employee, and client point of view. Jodi M. Pollock, Senior Medical Writer, inVentiv Health Clinical, Apex, NC Karen Blackburn, MS, Senior Medical Writer, inVentiv Health Clinical, Ann Arbor, MI
OS-68 | Target Audience: Preventing Tragedies on a Train [Writing/Editing] Accurate identification of target audience is the single most important skill in medical writing (or any writing). A thorough understanding of target audience drives the content, detail, comprehensiveness, vocabulary, voice, tone, and sophistication of whatever you’re writing, and your writing task is further challenged by the medium (live, print, electronic, etc). Learn how to assess your audience and purpose, to check to see if you have hit your target, and to write to the identified target. This seminar will address target audience across a broad range of medical documents, including books, promotional slide decks, detailing materials, continuing education courses, patient education, meeting summaries, grant proposals, and regulatory documents. You will have an opportunity to complete exercises to apply the concepts discussed. Kelleen N. Flaherty, MS, Biomedical Writing Programs, University of the Sciences, Philadelphia, PA
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full program schedule | Saturday 2:00–5:00 PM WS-64 | Microediting (ADV) [717]
Participants will sharpen their microediting skills by reviewing an assignment completed before the workshop and discussing the art of microediting as it relates to the preparation of manuscripts for medical journals. Organization of manuscripts will not be discussed (this topic is covered in Macroediting). APPROXIMATE HOMEWORK TIME: 6 HOURS.
Elliott Churchill, MS, MA, President, A World of Words, Atlanta, GA
WS-65 | Taxonomic Analysis of Medical Writing (ADV)
[732] This participant-centered workshop is designed to cover a wide range of medical writing. In a highly congenial setting, participants will receive feedback on their previously submitted sample (about 100 words) of their best medical writing or copyediting. During a group-tutorial format, participants will identify and suggest revisions to distractions (comprehension, non-professional tone, dissonance, and verbiage) at all textual levels of writing. These distractions will be classified in an individual taxonomy guide prepared for each participant to facilitate future distraction recognition, analysis, and revision. Pre-workshop homework—in addition to completion of the 100-word writing sample—will consist of identifying distractions in all the other participants’ writing samples. This workshop is a combination of two previous workshops: #710 and #715. Participants who have received credit for completing either workshop #710, Semantic Analysis of Medical Writing, or #715, Syntactic Analysis of Medical Writing, cannot receive credit for this workshop. Participants should check their curriculum records before signing up for this workshop. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Michael Lewis Schneir, PhD, Professor, Biomedical Sciences, Herman Ostrow School of Dentistry of USC, Los Angeles, CA
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WS-66 | Sentence Structure and Patterns (ES/G)
[2009] Through lecture and examination of flawed and improved sentence examples, participants will consider the main elements of sentence construction, accommodation to the reading process, and the management of emphasis—all with a view toward matching structure to purpose. APPROXIMATE HOMEWORK TIME: 2–5 HOURS.
Susan E. Aiello, DVM, ELS, Editor-in-Chief, The Merck Veterinary Manual, Merck & Co, Inc., Bluebell, PA
WS-67 | Essential Ethics for Medical Communicators
(ES) [2006] This workshop is required for individuals working to earn the Essential Skills certificate. The workshop leader will provide a basic overview of ethical considerations with a focus on the AMWA Code of Ethics. The workshop comprises a homework assignment, an interactive lecture, and a class exercise—all designed to address the variety of ethical situations that occur in medical communication. Participants will be divided into small groups to discuss the case studies submitted as homework assignments, name the ethical problem, identify the involved stakeholders and their perspectives, debate alternative decisions, and use role-playing to present to the entire group. This workshop is suitable for both entry-level and experienced medical communicators. APPROXIMATE HOMEWORK TIME: 3 HOURS. Same as WS-32.
Charmaine Cummings, PhD, CCMEP, CJ Cummings Consulting LLC, CEO, Annapolis, MD
WS-68 | Elements of Medical Terminology (ES/G/SG)
[2005] This workshop, which will consist mainly of lecture and exercises, is designed primarily for beginning medical writers with little or no medical background. Participants will learn how to understand the meanings of medical terms by identifying Latin and Greek word
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full program schedule | Saturday components. APPROXIMATE HOMEWORK TIME: 3 HOURS. Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX
WS-69 | Punctuation for Clarity and Style (ES/G)
[2008] Designed for communicators whose professional writing experience and grammatical savvy range from minimal to moderate, this discussion of the most useful punctuation rules and options—from the serial comma to the dash—will focus on emphasis, variety, and consistency. Medically oriented examples, including many sent in by participants, will be discussed. APPROXIMATE HOMEWORK TIME: 3–5 HOURS. Same as WS-29.
Helen E. Hodgson, PhD, Professor of Communication, Westminster College, Salt Lake City, UT
WS-70 | Bibliographic Resources for Medical
Communicators (ES/G) [2002] This workshop is an introduction to bibliographic resources in the medical sciences. The goal of the workshop is to enable workshop participants to become “information literate.” The primary focus will be on integrating different types of sources and search engines into the process of searching the peer-reviewed medical literature. PubMed and PubMed Central searches will be conducted during the workshop, and analyzed and discussed. Information concerning free access to information will also be included. APPROXIMATE HOMEWORK TIME: 3 HOURS.
Joan N. Nilson, Medical Policy Advisor, UPMC Health Plan, Pittsburgh, PA
WS-71 | Basic Grammar II and Usage (ES/G) [2001]
Customary practice, particularly with respect to language, can sometimes lead to unclear writing, especially when the writer is tempted to use informal or nonstandard English. This workshop builds on Basic Grammar I by reviewing additional grammatical topics and by
discussing some aspects of English usage. Topics to be covered include correcting dangling and misplaced modifiers, using who or whom and which or that, making subjects agree with verbs, writing clear comparisons, and choosing the correct word. APPROXIMATE HOMEWORK TIME: 3 HOURS. Same as WS-33. Flo Witte, PhD, ELS, Bluegrass Editorial Services Team, Winchester, KY
WS-72 | Launching a Freelance Writing Career (B/FL)
[2504] The workshop leader will explore strategies for starting a freelance writing or editing career. Included will be an overview of myths about freelancing and discussion of the pros and cons of a freelance career. Participants will learn strategies for finding clients, marketing their skills, preparing contracts, estimating project time, and setting fees. After completing the workshop, participants will be equipped with resources and tools for finding a path to success in freelancing. APPROXIMATE HOMEWORK TIME: 2 HOURS.
Eleanor Mayfield, ELS, Principal, ELM Communications, Pittsburgh, PA
WS-73 | Using Design to Improve the Readability of
Medical Documents (CP) [3028] In this combined lecture/discussion format, participants will learn basic principles of effective document design. The workshop will emphasize using design to make medical documents clear, readable, and accessible, not attractive per se. The presentation will focus on four principles of visual perception—contrast, alignment, repetition, and proximity—with applications ranging from the whole document to individual typographic characters. The discussion will include data displays such as charts and tables. No design experience is necessary. APPROXIMATE HOMEWORK TIME: 1.5 HOURS.
Lyn Gattis, PhD, Associate Professor, Department of English, Missouri State University, Springfield, MO
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full program schedule | Saturday WS-74 | Medical Writing for Instructionally Sound
Engaging e-Learning (CP) [3029] The recommended audience is new/beginner medical writers, or moderately experienced writers who are new to eLearning, who seek to expand their ability to write instructionally sound content for eLearning educational courses and training (including mobile, or mLearning). This workshop is geared for people who write (or seek to write) eLearning courses for workplace training, whether as contractors, on staff for a training company, or within the training department of a corporation, institution, or professional association. APPROXIMATE HOMEWORK TIME: 1−2 HOURS.
Michelle Nolin, CPLP, Senior Director, Product Strategy & Development, Informa Training Partners, Walpole, MA
WS-75 | Writing for Video (CP/EW/PRAM) [3023]
The workshop leader will focus on writing for video/ CD-ROM, an increasingly popular tool for medical education. Writing for this medium requires simultaneous use of the left brain and right brain; writers have to get their point across verbally and visually to hold viewers’ attention. Guidelines will be provided on how to create effective presentations: conceptual development, scriptwriting style, production commands, and some of the special interactive features of CD-ROMs. APPROXIMATE HOMEWORK TIME: 2 HOURS.
Nick Sidorovich, MSEd, President, Rolling Hill Media, LLC, Chatham, NJ
WS-76 | Plain Language (CP/EW) [3011]
In this basic workshop, writers and editors with little experience in preparing health information materials for readers with limited literacy skills will learn about writing plainly for this audience (at reading levels for grades 4 through 8). After a discussion of the principles of plain language, participants will practice writing plainly in a variety of exercises. APPROXIMATE HOMEWORK TIME: 3 HOURS.
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Amy D. Stephenson, MA, Senior Content Strategist, Waggener Edstrom Worldwide, New York, NY
WS-77 | Introduction to Cancer Pharmacology (SM)
[3512] This workshop is intended for beginning and moderately experienced writers and editors who have a basic understanding of cell biology, and will be taught through a combination of lecture and discussion. The workshop leader will focus primarily on elucidating—in conceptual, high-level terms—the mechanisms of common cancer drugs on the market, examining how key differences between normal and malignant cells allow for targeted therapies. Background information including the history of discovery of each drug will be provided. This workshop assumes a basic understanding of the principles of cell biology (eg, cell cycle, DNA replication, signal transduction). It would be helpful for participants to have taken the Basic Cell Biology workshop or the Introduction to Cancer Biology workshop. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Sunil Patel, MS, Drug Safety Associate II, Onyx Pharmaceuticals, South San Francisco, CA
WS-78 | Writing Clinical Evaluation Reports for
Medical Devices (RR) [4022] While the FDA extensively overhauls its submission process for medical devices, American companies are seeking European market authorization. However, there are major differences between the review and approval processes for medical devices in the European Union compared to the FDA. In particular, a clinical evaluation report is required for all European medical devices (excluding diagnostics). The workshop leader will provide practical advice for gathering and reporting valid clinical evidence in compliance with European Directive 2007/47/EC. This workshop is appropriate for regulatory/ medical communicators who are moderately experienced in writing clinical regulatory documents (such as
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full program schedule | Saturday Final Clinical Study Reports, Integrated Summary of Safety, Integrated Summary of Efficacy). Experience performing critical appraisal of the scientific literature also would be helpful. Knowledge of medical device development would be especially helpful. APPROXIMATE HOMEWORK TIME: 3 HOURS. Felicia R. Cochran, BS, PhD, Principal Clinical Research Specialist, Medtronic Inc, Minneapolis, MN
WS-79 | Writing an Informed Consent Form (RR/PH) [4000] Learn to write an informed consent form (ICF) for a clinical trial that is compliant with Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) guidelines. The workshop will include background/history of the informed consent process, information on applicable regulatory requirements, and techniques to make the ICF meaningful to potential research subjects. This workshop is intended for participants with little experience writing ICFs. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.
Michelle Eby, PharmD, CCRP, Consumer Safety Officer, Food and Drug Administration, Silver Spring, MD Paula Fischthal, MA, Senior Medical Writer II, MedImmune, a wholly owned subsidiary of AstraZeneca, PLC, Gaithersburg, MD
WS-80 | Investigational New Drug Applications (RR/
PH) [4008] This workshop is intended for writers with little or no experience in preparing documents for regulatory applications. The leader will cover the essential components of an investigational new drug application, FDA regulations, and the reviewers’ needs. Participants will also gain an understanding of the writer’s contribution to the quality of an electronic submission. Requirements and available online sources will be included. APPROXIMATE HOMEWORK TIME: 3–4 HOURS. Same as WS-41.
Jennifer Grodberg, PhD, RAC, Senior Director, Regulatory Affairs, Trius Therapeutics, Inc., San Diego, CA
WS-81 | Sifting Through Styles: Comparing
Predominant Publication Manuals (Non-Credit) Why are style manuals so important? How is an appropriate manual selected for a given project? Although the American Medical Association Manual of Style is a predominant guide in medical writing, other major publications—such as the Chicago Manual of Style or the Publication Manual of the American Psychological Association—can more suitably apply. This workshop will introduce distinguishing style points of these three manuals to help medical writers determine when and how to apply them.
Nicole Van Hoey, PharmD, Freelance, Arlington, VA
2:15–3:15 PM
2013-2014 BOARD OF DIRECTORS MEETING (by invitation) Presiding: Brian Bass, 2013-2014 AMWA President
3:30–5:00 PM OS-69 | Creative Readings
Back by popular demand, this fun, informal forum provides an opportunity for all poets, playwrights, novelists, short story writers, humorists, and essayists to bring a sample of work and share it with their fellow AMWA members. The purpose is to share and appreciate—not evaluate or criticize—in a comfortable, nonthreatening environment. Host: Donna Miceli, Fort Myers, FL
OS-70 | Don’t Just Sit There! Tips for Bringing Movement and Relaxation into Your Day [“Soft Topics”] Medical writers face daily stresses in body and mind: deadlines, sitting too much and other ergonomic
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full program schedule | Saturday strains, bad breathing habits, restless minds, and more. Even if you exercise daily, being sedentary and stressed for the rest of the day takes a toll on your health and well-being. Learn about some of the consequences of a sedentary job and get tips for incorporating movement and relaxation into your day, such as “booster breaks” and other strategies and exercises to help you become physically active while getting work done. A TriYogacertified instructor (and medical writer) will present 10 yoga tips to do right now: an in-the-flow experience to increase energy physically, mentally, and spiritually. Moderator (and speaker): Ann Winter-Vann, PhD, Medical Writer and Consultant, Whitsell Innovations, Chapel Hill, NC Wendell C. Taylor, PhD, MPH, Associate Professor, School of Public Health, University of Texas Health Science Center, Houston, TX Mary Kemper, Medical Editor, Mayfield Clinic; TriYoga Teacher, Cincinnati, OH
“Marketing Your Liberal Arts Background to Employers and Clients” Participants will discuss paths to enter the medical writing field with a liberal arts education, ways to emphasize their creativity and critical thinking skills rather than their major, proactive career development tasks; and methods to develop and refine their particular expertise. Tim Peoples, MA, ELS, CMPP, Medtronic, Inc., Santa Rosa, CA
“Transitioning from the Benchtop to Medical Writing: Rethinking the Format of Your CV” Participants will discuss the challenges of transitioning to the medical writing field from the laboratory setting, ways to effectively promote their skills and experience to potential employers, and review samples of medical writing job listings while discussing ways to rethink and map research experience to meet job requirements.
“Can You Hear Me Now? The Introvert’s Struggle to Be Heard in an Extrovert’s World” Participants will discuss the struggles of dealing with introverts or being an introvert, especially the unique challenges introverts face in the world of medical writing; consider strategies on how to survive and thrive in an extrovert’s world; and share success stories.
Lisa Humphries, PhD, Amgen Inc., Thousand Oaks, CA
David Clingan, inVentiv Health Clinical, San Antonio, TX
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Christine M. Durst, PhD, Durst Writing Solutions, Glen Mills, PA
OS-71 | Round Robin Table Talk
Grab a coffee, water, or soft drink (and snack too, if you want), and take advantage of an opportunity to participate in two 40-minute targeted discussions. Attendance is limited to 12 participants per discussion on a firstcome, first-served basis. Priority for seating will be given to attendees who participate in two discussions.
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“Making the Most of Your LinkedIn Profile” Participants will learn how tap into the full extent of what LinkedIn offers and implement specific changes to improve the visibility of their profile. The discussion will address how to use keywords, taglines, and searchable skills; target potential clients; demonstrate activities, certifications, and leadership in AMWA and other organizations; highlight projects for clients; and use the social media aspects of LinkedIn.
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OS-72 | What’s Your Problem? Problem-Solving Discussions Get help from your colleagues in solving one of your most challenging problems at these informal discussions. Four facilitated discussions will target challenges in regulatory writing, freelancing, writing, and editing. Attendance is limited to 12 participants per discussion on a first-come, first-served basis.
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SUNDAY TOURS Sunday, November 10 Columbus Zoo and Aquarium www.columbuszoo.org
Buckeye and Brutus
frolicking in the Columbus Zoo and Aquarium. Photo courtesy of www.touring-ohio.com.
The Columbus Zoo and Aquarium is a world of adventure that does a world of good. The Zoo is home to more than 9,000 animals representing 650 species from around the globe, including big cats, elephants, gorillas, manatees, bonobos, and more! Watch a polar bear swim above your head, meet the world famous gorilla family, say “G-Day” to the koalas, ponder the giant pachyderms, and be amazed by the manatees. The Zoo provides more than $1 million annually to support over 70 conservation projects worldwide. Please note there is no transportation once you are inside the facility, so be sure to wear comfortable shoes.
Time: depart: 9:30 AM; return: 3 PM (leave Zoo at 2:30 PM) Cost: $35 (includes transportation and Zoo admission, lunch is on your own)
www.shortnorth.org
Enjoy a leisurely stroll through Columbus’s hip Short North and savor its culinary delights while learning about the colorful history of this popular neighborhood. An experienced guide with a wealth of local culinary knowledge will lead you on the tour of the Short North, which is packed with Columbus’ best restaurants, art galleries, boutiques, and bistros. You’ll start at the historic North Market, Columbus’ only public farmers’ market, where you’ll meet some of the local food vendors and learn the history of the building. You will then stop at five eating establishments, sampling some of their signature dishes and hearing their stories. Stops will include some neighborhood
Short North Food Tour & Walking Tour
Street band at Short North. Photo courtesy of www.shortnorth.org.
favorites, some already highly regarded new additions, and some of the finest dining in the city, such as James Beard-nominated Kent Rigsby’s restaurant. Finish on a sweet note with a trip to the renowned Jeni’s ice creams, featured on the Food Network’s “America’s Best Sweets.” (Specific stops are subject to change.) You will walk approximately 1.5 miles, and the tour will take place rain or shine. You will be outside for just a few blocks at a time, but check the weather and dress appropriately.
Time: depart: 11:00 AM; return: 2:00 PM Cost: $55 (includes tastings at all stops)
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ca r e e r d e v e l o pm e n t
AMWA’s Certificate Program AMWA workshops allow medical communicators to increase their knowledge, refresh their skills, and investigate new areas. You may take credit workshops without enrolling in a certificate program, but you must be enrolled in the specific certificate program to which the workshop is applicable to receive credit toward that certificate. You may enroll in one or more of the certificate programs when you register for the Annual Conference. After enrolling in a certificate program, you have 6 years to complete the requirements to earn the certificate. Workshops may be taken in any order during that time. If you are not enrolled in a certificate program but participate in a workshop and wish to receive credit for that workshop, you must enroll in the certificate program to which the workshop is applicable within 90 days (by January 10, 2014, for workshops taken at the 2013 Annual Conference). In order to obtain credit, you must have successfully completed the homework and attended the entire workshop (3 hours). Multiple designations are included in workshop listings to accommodate people enrolled in both new and old certificate programs (see Key to Schedule on page 14). Credit for a workshop can be applied once—to one certificate only. AMWA awards the appropriate certificates when the requirements have been fulfilled. Please allow AMWA headquarters staff sufficient time after the conference to process the workshop credits.
Essential Skills certificate
Essential Skills (ES) workshops provide the basis for the certificate program and include skills that all medical communicators should have, regardless of job function or environment. To obtain the Essential Skills certificate, you must successfully complete eight workshops;
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Enrollment is available for AMWA’s Essential Skills certificate and four new specialty certificates: Business, Composition and Publication, Concepts in Science and Medicine, and Regulatory and Research. You may take workshops in the specialty certificate program at any time, but you must complete an Essential Skills, Core, or Advanced certificate before you can earn a specialty certificate. The new certificates have replaced the previously offered Core and Science Fundamentals certificates, but credits for workshops previously taken will not be lost; you can continue to pursue the previous certificates under your existing enrollment timeframe. Workshop listings include designations for both the new and old certificates.
one of these workshops must be Essential Ethics for Medical Communicators. Two sessions of this workshop will be offered in Columbus, and an Essential Ethics self-study module will be available for purchase at a discounted price.
Specialty certificates
To receive a Business, Composition and Publication, Concepts in Science and Medicine, or a Regulatory and Research certificate, you must have earned an Essential Skills, Core, or Advanced certificate and have successfully completed eight workshops within a specialty certificate program; one of these workshops must be the ethics workshop applicable to that specialty. Ethics workshops being offered at the 2013 Annual Conference: Business Ethics for Medical Communicators (B); Essential Ethics for Medical Communicators (ES); Ethical Standards in Medical Publication (CP); and Ethics
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AMWA’s Certificate Program in Communicating Science and Medicine (SM). You may take workshops in the specialty certificate program at any time, but you must complete an Essential Skills, Core, or Advanced certificate before you can earn the specialty certificate.
Specialty workshops
1. Business (B) workshops provide information to develop and expand freelance businesses, as well as management and operation skills for all medical communicators. 2. Composition and Publication (CP) workshops provide experienced medical communicators with specialized editing and publication skills, as well as in-depth consideration of issues in writing, editing, bibliographic research, education, and other topics of interest. 3. Concepts in Science and Medicine (SM) workshops workshops provide medical communicators with an opportunity to deepen their understanding of basic concepts in science and medicine. For those with a nonscience background, these workshops provide an orientation to a scientific area and a foundation for further study. For those with a science background, these workshops offer opportunities to enhance knowledge and to learn about areas outside current specialties.
4. Regulatory and Research (RR) workshops provide experienced medical communicators with specialized skills in regulatory and drug development writing.
Workshop designations
Credit for a workshop can be applied only once, and workshops are given a designation that reflects the certificate program to which they currently apply. (A full list of abbreviations can be found on page 14.)
Noncredit (NC) workshops are not part of the certificate program, but they are also appropriate for all medical communicators seeking to increase their knowledge and refresh their skills. In addition, they are regularly evaluated, and some may be incorporated into the certificate program in the future.
Pre-course work (homework)
Each credit workshop includes homework. Typically, the purpose of the homework is to give participants needed background information for the workshop and also to help the workshop leader assess the skill levels of participants. Once your registration has been processed, you will receive an e-mailed confirmation, which will include the URL for downloading electronic homework from the web. Almost all homework for credit workshops is available electronically. We strongly encourage you to download homework immediately after you receive your confirmation to ensure that the downloading process is successful, to confirm that the homework is correct for the workshop, and to note the deadline stated on the specific homework. A delay in downloading the homework and identifying potential problems could result in inability to complete the homework by the deadline. If you have difficulty accessing the homework or URL within 10 days of registering for the conference, please contact AMWA headquarters by e-mail at annual_conference@amwa.org or by telephone at 240-238-0940, ext 103. You are also responsible for verifying that your workshop leaders have received your completed homework by the deadline. Credit for the workshop will not be given if the homework arrives late. Workshop leaders must receive completed homework by October 15 unless an earlier deadline is indicated by the workshop leader on the homework.
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ethics
Annual conference committee Even if you do not wish to receive credit for a workshop, you are encouraged to complete the homework to be better prepared to fully participate in the workshop. If you register for an Advanced workshop, you must be prepared to participate in the workshop discussion and thus, you must complete the homework and submit it to the workshop leader by the deadline, regardless of whether you wish to receive credit for the workshop. If a registrant’s homework for an Advanced workshop is not received by the deadline, he or she will not be allowed to attend the workshop, and no workshop credit or refund will be given.
For details on registering for workshops at the AMWA Annual Conference, please see page 9.
Annual Conference Committee Chair: Lori L. Alexander, MTPW, ELS Editorial Rx, Inc., Orange Park, FL Keightley Amen ONS: Edge, Pittsburgh, PA Lora Arduser, PhD University of Cincinnati, Cincinnati, OH Noelle Demas, MS Panorama MedWriters Group, Inc, San Diego, CA Alexandra Howson, PhD Thistle Editorial, LLC, Snoqualmie, WA Charlotte Kenreigh, PharmD UBC-Envision Pharma Group, Southport, CT Larry Lynam The Lynam Group, Coral Springs, FL Joanne McAndrews, PhD St. Louis, MO Yeshi Mikyas, PhD, ELS, CMPP Amgen Inc., Thousand Oaks, CA Donna Miceli DLM Writing Services, Ft. Myers, FL Cyndy Kryder, MS, CCC-Sp Phoenixville, PA Linda Wagner, PharmD UBC-Envision Pharma Group, Southport, CT Christine Welniak Upside Communications, Brooklyn, NY
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r e g u l at o ry w r i t i ng
2012–2013 Executive Committee
PRESIDENT Douglas Haneline, PhD Professor of English, Ferris State University Big Rapids, MI PRESIDENT-ELECT Brian Bass President, Bass Advertising & Marketing, Inc. Robbinsville, NJ IMMEDIATE PAST PRESIDENT Barbara R. Snyder, MA Senior Director of Medical & Scientific Communication, Onconova Therapeutics, Inc. Pennington, NJ SECRETARY Stephen N. Palmer, PhD, ELS Senior Scientific Medical Writer, Texas Heart Institute Houston, TX TREASURER Christine F. Wogan, MS, ELS Program Manager, MD Anderson Cancer Center Houston, TX 2013 ANNUAL CONFERENCE ADMINISTRATOR Lori L. Alexander, MTPW, ELS President, Editorial Rx, Inc. Orange Park, FL AWARDS ADMINISTRATOR Deborah A. Whippen Vice President, Editorial Rx, Inc. Orange Park, FL
CERTIFICATION COMMISSION CHAIR AND MEMBER AT LARGE Karen Potvin Klein, MA, ELS Wake Forest University Health Sciences Winston-Salem, NC CHAPTER RELATIONS ADMINISTRATOR Katharyn Spiegel, PhD Regulatory Writing Senior Manager, Amgen Inc. Grass Lake, MI EDUCATION ADMINISTRATOR Faith E Reidenbach, ELS, CMPP Partner, Caley-Reidenbach Consulting, LLP Philomath, OR
MEMBER RESOURCES ADMINISTRATOR Tamara D. Ball, MD Principal Medical Writer, inVentiv Health Clinical Asheville, NC
EXECUTIVE DIRECTOR Susan Krug, CAE DEPUTY DIRECTOR Shari Rager, CAE EDUCATION AND CERTIFICATE PROGRAM MANAGER Lauren Ero, MS, MEd CONFERENCE PROGRAM MANAGER Becky Phillips EDUCATION AND CONFERENCE PROGRAM ASSISTANT Melanie Canahuate
EXECUTIVE DIRECTOR (Ex Officio) Susan Krug, CAE PUBLICATIONS ADMINISTRATOR Anne Marie Weber-Main, PhD Asst. Professor of Medicine, University of Minnesota Minneapolis, MN
AMWA STAFF
EDUCATION AND CONFERENCE PROGRAM ASSISTANT Nyounti Tuan MEMBERSHIP MANAGER AND DATABASE COORDINATOR Ann Silveira MEMBERSHIP SERVICES ASSOCIATE AND PUBLICATIONS MANAGER Rachel Spassiani, MA MEMBERSHIP PROGRAM ASSISTANT Samantha Nelson
ONLINE COMMUNITY ADMINISTRATOR Kristina M. Wasson-Blader, PhD President, KWB Health Communications, Inc. Edmond, OK
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EXPANDING OUR HORIZONS
sponsors and exhibitors sponsors
exhibitors
SILVER
BRONZE
Regulatory Writing Experts
CHAPTER sponsors Delaware Valley Empire State–Metro New YorK FLORIDA PACIFIC SOUTHWEST SOUTHEAST *AMWA does not endorse any of the products or services associated with exhibitors, sponsors other than AMWA chapters), or session speakers at its annual conference. Conference exhibitors and sponsors do not influence the content or selection of presenters for workshops or programming at the AMWA Annual Conference. Sponsors and Exhibitors as of July 2013.
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