The Ultimate Educational Event for Medical Communicators
registration brochure www.amwa.org/events_annual_conference
AMWA’S 74TH ANNUAL CONFERENCE OCTOBER 8–11, 2014
Register Early and Save at www.amwa.org
welcome Whether you write or edit for the pharmaceutical industry, health care professionals, or lay audiences, participation in the 2014 AMWA Annual Conference will enhance your knowledge and professional skills. This year’s conference is packed with exciting session formats, a plethora of expert speakers, presentations on timely topics, and a host of networking events. The 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 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 (opening and closing) with award-winning speakers, open sessions on a wide variety of topics, the Exhibit Hall, and several networking events, including • • • • • •
Wednesday evening Welcome Reception Thursday Lunch in the Exhibit Hall Thursday evening Networking Reception Friday Networking Breakfast Friday AMWA Sablack Awards Luncheon Saturday Closing Reception: 75th Anniversary Kickoff Celebration
© The Commercial Appeal
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AMWA’s 74th Annual Conference
highlights of the 2014 conference Sablack Awards Luncheon This year, every conference attendee has the opportunity to hear the recipient of AMWA’s highest member award speak, with the move of the Dinner to a free Luncheon on Friday. The Sablack Awards Luncheon is now another great networking event for all attendees, adding to the value of your conference registration fee. In addition to the Swanberg Award, the Golden Apple Award and AMWA Fellowships will also be presented at the luncheon. Come join in celebrating your fellow members’ achievements! (Look for the presentation of additional AMWA awards at other sessions and events throughout the conference.)
Closing Reception Get All Shook Up for the 75th Anniversary Celebration! Next year marks the 75th anniversary of AMWA, and plans are underway for a full year of celebrating. Join us Saturday evening at the Closing Reception to kick off the celebration that will culminate in the 2015 Annual Conference in San Antonio.
AMWA’s Mobile Conference App Keep up to date with conference information and speakers with AMWA’s mobile conference app! This free app can be downloaded and viewed on a mobile device or computer. AMWA’s mobile conference app allows you to create a list of favorite sessions and speakers and make your own personalized schedule. You can also look up speakers by first or last name to see all the sessions in which they are participating. Learn more at www.amwa.org/events_annual_ conference.
Track Facts This year, it’s easier than ever to find the program events that best fit your interests and professional goals. We have expanded the use of tracks to include all sessions—workshops, open sessions, roundtables, and posters—to develop Track Facts—simple reference guides that include all sessions within each track. Track Facts are available for the following tracks: Editing, Ethics, Freelance, Health and Medicine, PR/Marketing, Professional Development, Professional Relationships, Regulatory, Relevant Skills, Social Media and Technology, Writing for Lay Audiences, and Writing for Professional Audiences.
The new Track Facts, coupled with the new Program at a Glance, will help you create your unique program quickly and easily. Track Facts will also help you demonstrate the value of the annual conference to your boss or to yourself, if you’re a freelance. Track Facts and the Program at a Glance are available on the AMWA website at www.amwa.org/events_ annual_conference.
Graceland and St. Jude Tours No visit to Memphis is complete without a visit to Graceland! Even if you’re too young to have been an Elvis fan, Graceland offers a glimpse into a historic time and an even more historic celebrity. Tours of Graceland, with transportation, will be offered on both Wednesday and Sunday, starting with pick-up at 9:30 AM at the AMWA hotel (the Sheraton) and returning between 1:00 and 1:30 PM. The ticket price is $40 and includes transportation to and from the host hotel. For medical communicators, a highlight of Memphis is a tour of St. Jude Children’s Research Hospital. Two tours exclusively for AMWA conference attendees are planned for Wednesday, one at 1:00 PM and one at 3:00 PM. Space for each tour is limited. The cost for transportation to the Hospital is $10.
AMWA Community Lounge and Demo Room AMWA’s Community Lounge is a designated area for attendees to meet up with colleagues, catch up on e-mails, or participate in hands-on demonstrations of the tools they heard about in the Exhibit Hall or in open sessions.
Information Tables Learn more about how to become a workshop leader, how to prepare for AMWA’s Medical Writing Certification Exam, or how to become involved in the AMWA Journal. Stop by the information tables near the registration desk and Exhibit Hall to talk with AMWA staff and volunteers about these important programs and initiatives. In addition, the AMWA Authors table returns! If you’re an author, sign up for a time to greet people and sell your book by sending an e-mail to amwa_conference@amwa.org. And, new this year, you can meet AMWA award winners at the Authors table! A schedule of authors and award winners will be posted onsite.
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CONTENTS Educational Program Information . . . . . . . . . . . 5 Award Speakers . . . . . . . . . . . . . . . . . . . . . . . . 5 Schedule at a Glance. . . . . . . . . . . . . . . . . . . . . 6 Registration Information. . . . . . . . . . . . . . . . . . 8 Hotel and Location Information . . . . . . . . . . . . 11 Full Program Schedule . . . . . . . . . . . . . . . . . . . 12 Wednesday. . . . . . . . . . . . . . . . . . . . . . . . 13 Friday. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Saturday . . . . . . . . . . . . . . . . . . . . . . . . . . 37
©Baxter Buck
Thursday . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Sunday. . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 AMWA's Certificate Program . . . . . . . . . . . . . 50 Annual Conference Committee. . . . . . . . . . . . 52 2013-2014 Executive Committee . . . . . . . . . . . 53 AMWA Staff. . . . . . . . . . . . . . . . . . . . . . . . . . 53 Sponsors and Exhibitors . . . . . . . . . . . . . . . . . 54
WS-35 • Strategies for Improving Document Quality for Pharmaceutical Communications Managers 3 credit hours in Publication Plan Implementation OS-05 • Rules of Engagement: Writers and Editors 1.5 credit hours in Implementation
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So You Want to be an AMWA Workshop Leader… Interested in leading a workshop for AMWA? Wondering how to go about it? Stop by and chat with an experienced workshop leader to learn more about what’s involved, what content areas are in need of workshops, whom to contact, and how to apply. We will be available at the following times, so come by to ask a question or pick up information. Wednesday, October 8
6:30–8:00 PM
Thursday, October 9
5:00–6:00 PM
Friday, October 10
7:30–9:00 AM
Location: Registration Foyer
AMWA’s 74th Annual Conference
educational Program information We tailor our programming to the profession and continually review 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.
Workshop participation requires an additional fee, and 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 50.
AMWA has developed 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 as many sessions as possible on his or her preferred topic.
Open sessions are informational sessions that are included with your registration. There is no additional fee or registration required. Intensive Seminars provide a more robust learning experience in a particular area, especially one that is outside the expertise of typical AMWA members. Intensive Seminars are limited to 60 attendees. Roundtable discussions are led by a facilitator who has experience with the topic. The discussions are interactive, 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.
AMWA’s 2014 Annual Conference offers workshops, open sessions, intensive seminars, and roundtables. Workshops are 3-hour intensive, small group training programs designed to enhance the skills of medical communicators.
award speakers |
A schedule and educational program list can be found beginning on page 12.
Our lineup 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 McGovern Award Winner Gary Schwitzer
AMWA Alvarez Award Winner Rosemary Gibson, MSc
Publisher, HealthNewsReview.org, and Adjunct Associate Professor, University of Minnesota School of Public Health
Senior Advisor to The Hastings Center and Section Editor for the Less is More series in JAMA Internal Medicine
Gary Schwitzer has a 40-year career in health care journalism, working in all media, including print, radio, television, interactive multimedia, and the Internet. But his pride and joy has been his latest project—the only health care news watchdog service of its kind in the United States.
Rosemary Gibson has dedicated her career to giving voice to patients and the public interest in critical health care issues in the United States in recent decades. Her work has improved the quality of life for untold numbers of people at the end of life and their families, and improved the safety of care that Americans receive throughout the course of life.
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Schedule at a glance WEDNESDAY October 8
Preliminary schedule as of June 2014
9:30 AM–12:30 PM BELS Examination
9:30 AM–1:30 PM Graceland Tour
11:00 AM–12:30 PM 2013–2014 AMWA Executive Committee Meeting (by invitation)
12:45–3:00 PM Scientific Tour of St. Jude Children's Research Hospital
1:00–3:30 PM 2013–2014 AMWA Board of Directors Meeting
1:00–4:30 PM Exhibitor and Poster Setup
2:00–7:00 PM Conference Registration and AMWA Information Desk Open
2:45–5:00 PM Scientific Tour of St. Jude Children's Research Hospital
4:00–5:30 PM AMWA Chapter Delegates Meeting
4:30–6:15 PM New to AMWA Event—Steps to Success: Annual Conference, AMWA, and Beyond
THURSDAY October 9
6:30–8:00 PM Exhibit Hall Open, Posters on Display
6:30–8:00 PM Welcome Reception (with cash bar; Exhibit Hall )
7:00 AM–6:00 PM Conference Registration and AMWA Information Desk
7:30–8:45 AM Roundtable Discussions with Breakfast (additional fee)
9:00–10:30 AM General Session, featuring McGovern Medal Award Address, “Too Much of the Wrong Kind of Health News,” by Gary Schwitzer
10:30–11:00 AM Sponsored Beverage Break (Exhibit Hall)
10:30 AM–4:00 PM Exhibit Hall Open with AMWA Community Lounge and Demos
11:00–12:00 PM Open Sessions
12:15–1:30 PM AMWA Workshop Leader Lunch (by invitation)
12:15–1:45 PM Lunch in the Exhibit Hall (included with registration fee)
2:00–5:00 PM Workshops and Open Sessions
3:00–4:00 PM Sponsored Beverage Break (Exhibit Hall )
5:00–6:00 PM Exhibit Hall Open Networking Reception (with cash bar; Exhibit Hall)
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6:15 PM Chapter Greet & Go
AMWA’s 74th Annual Conference
Schedule at a glance FRIDAY October 10
7:00 AM–4:00 PM Conference Registration and AMWA Information Desk
7:30–9:00 AM Continental Breakfast with the Exhibitors and Passport Prize Awards (included with registration) Visit with the Poster Presenters 7:30 AM–12:00 PM AMWA Community Lounge and Demos
7:30 AM–2:00 PM Exhibit Hall Open, Posters on Display
9:00 AM–12:00 PM Workshops and Open Sessions
10:00–11:00 AM Sponsored Beverage Break (Exhibit Hall)
12:15–1:45 PM
AMWA Sablack Awards Luncheon (included with registration), featuring the Swanberg Award Lecture, "Memories, Observations, and Predictions: the Past, Present, and Future of Medical Writing in Japan and Asia," by J. Patrick P. G. Barron
2:00–5:00 PM Workshops and Open Sessions
AMWA Community Lounge and Demos Exhibit Hall and Poster Take-down
SATURDAY October 11
3:00–4:00 PM Sponsored Beverage Break
6:00–8:00 PM Dine Arounds
8:00 AM– 3:00 PM Conference Registration and AMWA Information Desk 9:00 AM–12:00 PM Workshops and Open Sessions AMWA Community Lounge and Demos
10:00–11:00 AM Beverage Break 12:15–1:30 PM Roundtable Discussions with Lunch (additional fee)
1:45–3:15 PM Open Sessions
2:00–2:45 PM Annual Business Meeting
3:00–3:30 PM Beverage Break
3:30–5:00 PM General Session, featuring Alvarez Award Address, “Becoming a Medical Writer: the Journey and the Destination," by Rosemary Gibson, MSc
SUNDAY October 12
5:00–6:00 PM Closing Reception: 75th Anniversary Kickoff Celebration (cash bar)
9:30 AM–1:30 PM Graceland Tour
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registration information • • • • •
Registration opens: July 1, 2014 Early registration rates: July 1 through August 30, 2014 Regular registration rates: August 31 through September 26, 2014 Last day to register before onsite registration rates apply: September 26, 2014 Onsite registration rates: October 8 through 11, 2014
AMWA ANNUAL CONFERENCE FEES Full Conference Registration
EARLY
REGULAR
ONSITE
AMWA Member
$475
$575
$650
Nonmember
$645
$695
$750
AMWA Student Member
$200
$200
$250
Student Nonmember
$300
$300
$300
EARLY
REGULAR
ONSITE
AMWA Member
$175
$200
$250
Nonmember
$220
$250
$300
AMWA Student Member
$75
$75
$100
Student Nonmember
$200
$200
$200
EARLY
REGULAR
ONSITE
AMWA Member
$110
$110
$150
Nonmember
$135
$135
$150
EARLY
REGULAR
ONSITE
AMWA Member
$130
$130
n/a
Nonmember
$155
$155
n/a
ONE DAY Registration
AMWA WORKSHOP FEES credit WORKSHOP
ADVANCED credit WORKSHOP
All AMWA credit workshops having mandatory pre-course work (homework) that must be completed and submitted to the leader no later than September 17, 2014. Some workshop leaders require hard copy written submissions to be submitted by mail, and the homework must be received by (not postmarked by) September 17, 2014.
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AMWA’s 74th Annual Conference
registration information special events
EARLY/REGULAR
ONSITE
$28
$30
Included with registration
Included with registration
$40
$45
Continental Breakfast with the Exhibitors, Friday, October 10
Included with registration
Included with registration
AMWA Sablack Awards Luncheon, Friday, October 10
Included with registration
Included with registration
$35
$40
Included with registration
Included with registration
Graceland Mansion Tour with Roundtrip Transportation to/from Sheraton Wednesday, October 9 or Sunday, October 12, 9:30 AM–1:30 PM
$40
$45
St. Jude Scientific Tour with Roundtrip Transportation to/from Sheraton
$10
$10
Breakfast Roundtable, Thursday, October 9 Networking Lunch in the Exhibit Hall, Thursday, October 9 Intensive Seminar
Lunch Roundtable, Saturday, October 11 Wednesday, Thursday, and Saturday Evening Networking Receptions (cash bar)
General Registration Information
Registration for Special Events
Conference registration is an online process. 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.
Reservations are required for special events, and you must reserve your space during the registration process. For events that have limited attendance (Intensive Seminars and Roundtable Discussions), reservations are made on a first-come, first-served basis. Please note that that the Thursday and Friday lunches are free with registration; however, you must register for these events so that AMWA may plan accordingly.
All AMWA credit workshops include mandatory precourse work (homework) that must be completed and submitted to the leader no later than September 17, 2014. Some workshop leaders require hard copy written submissions by mail, and the homework must be received by (not postmarked by) September 17, 2014.
Guest Policy A guest at an AMWA conference is defined as a spouse, partner, friend, adult child (21 years and older) or other family member. A professional colleague who plans to attend educational programming may not register as a guest. He or she must pay the appropriate registration fee. Guests are admitted only to evening receptions.
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registration information Guest tickets may be purchased for the evening receptions. You can purchase guest tickets online through the registration form or onsite at the conference.
Policy on Children If children accompany a parent to any AMWA event, arrangements should be made for their supervision. No one under 21 years of age 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.
Cancellation/Refunds If you must cancel your conference registration, you must send a written note to cancel registration and request a refund via e-mail to annual_conference@amwa.org no later than September 17, 2014. Refunds will be issued through your method of payment, less a non-transferrable $75 cancellation fee. Conference registration is nonrefundable after September 17, 2014. Roundtable and tour cancellations are subject to $10 cancellation fee. Fees for roundtables and tours are nonrefundable after September 17, 2014. Workshop cancellations/changes are subject to a $35 cancellation fee. Fees for workshops are nonrefundable after September 17, 2014. No refunds or credits will be given for failure to attend, late arrival, unattended events, or early departure. 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 fees will be refunded. AMWA may not know it needs to cancel a workshop until a time closer than 14 days.
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 annual_conference@amwa.org or by telephone at 240-238-0940, ext 103.
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Participants with Special Needs If you have a special need that may affect your participation in the 2014 Annual Conference, please contact annual_ conference@amwa.org before September 19, 2014, to indicate your requirements and/or request accommodations.
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 Onsite If you have registered in advance, you can pick up your registration packet in the registration area beginning at 2:00 PM on Wednesday, October 8 in the Convention Center in the Ballroom Foyer on the third floor. The packet will contain your identification badge and onsite program. You can also register onsite at the same location. AMWA staff will be available throughout the conference to answer your questions about membership services and benefits.
New Members and First Timers If you’re a new AMWA member or have never attended an AMWA annual conference, don’t worry about being alone— lots of AMWA members and staff are on hand to help welcome and guide you. The traditional New to AMWA event has been enhanced to focus on providing the most relevant information and resources to new members and first-time attendees. The event will feature AMWA staff, chapter leaders, and conference mentors who will help first-time attendees get the most out of the conference. The new Steps to Success: Annual Conference, AMWA, and Beyond will be held Wednesday, 4:30 to 6:15 pm.
AMWA’s 74th Annual Conference
AMWA’s 74th Annual Conference will take place at the Memphis Cook Convention Center. AMWA has hotel sleeping room blocks at the Sheraton Memphis Downtown Hotel and the Crowne Plaza Memphis. Be sure to reference the AMWA Annual Conference to receive the discounted group rate. We expect the room blocks to fill, so make your reservation early! All reservations made after the blocks are filled and/or after the deadline will be booked at the hotel’s prevailing rate and availability is not guaranteed. Sheraton Memphis Downtown Hotel–AMWA Headquarters Hotel, connected to the Convention Center 250 N Main St, Memphis, TN 38103 Book Online https://www.starwoodmeeting.com/ StarGroupsWeb/res?id=1311062462&key=AB2D1 Reservations: 1-800-325-3535 (Reference AMWA Annual Conference for discount) Rate: $149.00 per night plus tax. Rate includes wireless Internet access in sleeping rooms. Discounted room rate is available until September 8, 2014. Crowne Plaza Memphis Located across the street from the Convention Center and the Headquarters hotel 300 North Second Street, Memphis, TN 38105 Reservations: 1-901-525-1800 (Reference AMWA Annual Conference for discount) Rate: $144.00 per night plus tax. Rate includes wireless Internet access in sleeping rooms. Discounted room rate is available until September 8, 2014.
©Sheraton Memphis Downtown Hotel
Hotel and Location information
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 here 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 hotels listed here and identify yourself as an AMWA conference attendee.
Travel Information Memphis is an affordable city with a lot of fun things to do! AMWA is ready to Shake, Rattle, and WRITE its way to Memphis, TN. Downtown Memphis is home to the National Civil Rights Museum, Smithsonian’s Rock’n’Soul Museum, Beale Street entertainment district, and much, much more... and Graceland is just 10 miles away! Learn more about all that Memphis has to offer. Local AMWA members share their favorite Memphis attractions. Memphis is ready to welcome AMWA and help you plan a fantastic trip. Delta Airlines is pleased to offer up to 10% off applicable airfares for the 2014 AMWA Annual Conference. To take advantage of this discount, book your flight online and enter NMJ63 in the Meeting Event Code box. Memphis International Airport hosts six airlines with three terminals. The airport is an approximately 15-minute drive from the Memphis Cook Convention Center, Sheraton, and Crowne Plaza. The Memphis International Airport has more information for arriving passengers to help you navigate your trip.
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Full Program Schedule • KEY KEY TO SCHEDULE
Abbreviations
PH Pharmaceutical
IS Intensive seminar
OS Open session (includes Topic Seminars, Panel Presentations, How-To Sessions, Pro/Con Debates, and Hands-on Demonstrations) WS Workshop
T Thursday Roundtable Discussions with breakfast
S Saturday Roundtable Discussions with lunch
Program Tracks Again this year, we have assigned tracks to open sessions to make it easier to find the sessions that best fit your interests and professional goals. In addition, we have assigned tracks to workshops this year. Tracks include Ethics, Freelance, Grants, Health and Medicine, PR/Marketing, Professional Development, Professional Relationships, Regulatory, Relevant Skills, Soft Topics, Technology/Social Media, and Writing/Editing. 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 Business
RR Regulatory and Research SM Concepts in Science and Medicine For people enrolled in one of the Specialty certificate programs G General
ED Educators EW Editing/Writing
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January 31, 2010, and are working to complete a Core certificate in one of the program areas
ADV Advanced For people who enrolled in the Advanced certificate program before January 31, 2010, and are working to complete that certificate
• Register early if you plan to enroll in credit workshops, which often fill quickly. Space is assigned on a first-come, firstserved basis, and credit workshops are limited to 30 participants. Advanced workshops are limited to 16 participants. • 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 credit workshop includes homework to be completed before the conference. To be eligible to receive AMWA certificate credit, homework must be returned to the workshop leader by the due date of September 17, 2014. • 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. More information about AMWA’s certificate program is available starting on page 50.
CP Composition and Publication
PRAM Public Relations/Advertising/Marketing For people who enrolled in the Core certificate program before
Important Information Regarding Workshop Participation
Golden Apple Award Recipient for excellence in teaching in the AMWA education program
FL Freelance
NOTE: Please review your AMWA curriculum history to see what credits you have earned and how many are still needed to earn your certificate. To access your curriculum history, log in to the AMWA website (www.amwa.org) and use the Quick Links Menu. Locate the Account Management subheading and follow the link to My Curriculum History.
AMWA’s 74th Annual Conference
Full Program Schedule • wEDnesday WEDNESDAY, October 8
2:45–5:00 PM
9:30 AM–12:30 PM BELS Examination (Registration is available through the Board of Editors in the Life Sciences, www.bels.org.)
9:30 AM–1:30 PM
Scientific Tour of St. Jude Children's Research Hospital See description at 12:45-3:00 PM time slot.
4:00–5:30 PM
GRACELAND TOUR Put on Your Blue Suede Shoes and tour this historic site. Even if you’re too young to have been an Elvis fan, Graceland offers a glimpse into a significant time in music history and a peek into the life of an extraordinary man. Transportation will pick you up at 9:30 AM at the AMWA hotel (the Sheraton) and will return between 1:00 and 1:30 PM. The ticket price is $40.
11:00 AM–12:30 PM 2013–2014 AMWA Executive Committee Meeting (by invitation)
12:45–3:00 PM Scientific Tour of St. Jude Children's Research Hospital St. Jude Children’s Research Hospital is leading the way the world understands, treats, and defeats childhood cancer and other deadly diseases. On this high-level tour, presented by hospital employees, you will see the hospital in action. From the Registration area where patients and families check in each visit to the bone marrow transplant center, you’ll get a well-rounded view of what St. Jude does and how it does it. You’ll visit the research areas and learn about how the “bench to bedside” approach is fully integrated on all levels. Your guide will share information about founder Danny Thomas and the history of the hospital, as well.
1:00–3:30 PM 2013–2014 AMWA Board of Directors Meeting
1:00–4:30 PM Exhibitor and Poster Setup
2:00–7:00 PM Conference Registration and AMWA Information Desk Open
AMWA Chapter Delegates Meeting 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.
4:30–6:15 PM New to AMWA—Steps to Success: Annual Conference, AMWA, and Beyond If you’re a new AMWA member or have never attended an AMWA annual conference, join us to learn how to get the most out of the conference, with expert advice on must-do sessions and events tailored to your interests and professional goals. Also discover how AMWA programs, products, and services can help enhance your professional skills and how you can further expand your professional reputation by becoming more involved in AMWA. If you are an AMWA newcomer and plan to register for this event, please complete a four-question survey so that we can better meet your needs. All those who complete the survey will receive a complimentary copy of AMWA Journal Collections: Exploring a Career in Medical Communication. Don’t miss out on this opportunity to get a valuable resource free! Complete the survey today.
6:30–8:00 PM Exhibit Hall open, Posters on display Welcome Reception in the Exhibit Hall Join your colleagues in a fun and informal setting with hors d’oeuvres and a cash bar. The program includes a welcome to the conference and the presentation of the Student Scholarship Award, sponsored by the University of the Sciences in Philadelphia. It’s also your first chance to visit with exhibitors and browse the posters. (See page 26 for the list of accepted posters.)
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Full Program Schedule • THURSday THURSDAY, October 9
Martin J. Spiering, PhD, ELS, Science Editor, CSR, Incorporated, Gaithersburg, MD
7:00 AM–6:00 PM Conference Registration and AMWA Information Desk open
7:30–8:45 AM Roundtable Discussions with Breakfast (additional fee) Roundtable discussions are led by a facilitator who has experience with the topic. The discussions are interactive, 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-01 • Can I Be a Freelance? A great many people new to medical writing enter it thinking they want to be a freelance. While it’s tantalizing to think you can push back the frontiers of promotional writing while stretched out in your jammies on the couch with your cat curled up in your lap (arguably, that IS pretty sweet), there are a number of things to consider. First, new writers rarely freelance. Second, some important things must be considered with regard to your own discipline and resources. Finally, there's the business end (surprise: it's a lot of work). Kelleen N. Flaherty, MS, Assistant Professor, Biomedical Writing Programs, University of the Sciences in Philadelphia, Philadelphia, PA
T-02 • Certification of Editors in the Life Sciences Join this roundtable discussion to learn about the meaning of professional certification in editing and the history, status, and procedures of the Board of Editors in the Life Sciences. Norman Grossblatt, ELS(D), Senior Editor, The National Academies, Chevy
Ben J. Pakuts, Msc, AMWA-ES, Communications Project Specialist, University Health Network, Ontario
T-05 • Demonstrating Leadership When You’re Not the Leader Medical writers often serve in supportive roles, driving decisions rather than making them. Yet, a writer’s credibility and professionalism can influence the quality of his or her interactions and how effectively projects are completed. In addition to strong writing skills, medical writers frequently rely on strong leadership skills to achieve project success. Selfawareness, composure, social competence, and drive greatly impact your effectiveness. In this roundtable, we will discuss these attributes and suggest methods for improvement. This roundtable is relevant for attendees who have an interest in professional development, particularly those who work directly with authors or in team environments. This roundtable is offered again on Saturday. Lori M. Smette, PhD, Medical Writing Senior Manager, Amgen, Inc., Thousand Oaks, CA
Chase, MD
T-03 • Challenges and Opportunities for Scientific Editing Scientific editing of journal manuscripts is a central pillar of biomedical research and ensures effective communication of research findings. Join us at this roundtable to discuss the different facets of scientific editing, the resources available, the skills required, the credentials that can make one competitive in the field, and career opportunities.
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T-04 • Creating Powerful Printed Reports and Newsletters: from Concept to Completion Preparing a printed report requires the mingling of a wide range of skills—from creative brainstorming techniques, to content mining, writing for different audiences, and copyediting. Knowledge of the desired layout and printing process is also required from the earliest stages. This roundtable will focus on key aspects of the process, allowing for group discussion and the sharing of different experiences to identify common hurdles and how to overcome these in order to create an appealing and highly readable printed report.
T-06 • Determining the Value of Editors in Medical Writing This roundtable discussion will focus on when to bring an editor into a project, what an editor adds to the team, and how to measure the value of an editor. David M. Clingan, Senior Medical Editor, inVentiv Health Clinical, San Antonio, TX
AMWA’s 74th Annual Conference
Full Program Schedule • THURSday T-07 • Editing and Proofreading Your Own Work Few of us always have the luxury of calling on professional editors and proofreaders before submitting, publishing, or posting our work. And even when such service is available, doing some editing or proofreading oneself is often advisable. This roundtable discussion will focus on approaches, tips, and resources for editing and proofreading one’s own work. Attendees will receive checklists and a resource list and will have ample opportunity to ask questions and share ideas. Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX
T-08 • Cancelled T-09 • FDA, GMP, and GCP and Their Relationship to Medical Writing A portion of medical writers works under either the Good Manufacturing Practices (GMP) or Good Clinical Practices (GCP) guidelines provided by the FDA. Understanding how the GMP and GCP affect our work can be beneficial to us as well as our work. This roundtable discussion will provide a review of the basic principles of the GMP and GCP and provide a forum for discussing their relationship with medical writing. James C. Barnett, CQE, Medical Writer, Inventiv Health Clinical, Wilmington, NC
T-10 • Freelancing: Starting and Marketing Your Medical Writing Business You understand the science and can communicate it effectively. The freelancing career beckons as an exciting and perfect career choice. You start your own freelance business, you get business cards, you join AMWA, and you enroll in its certificate program. You are on your way! But, soon comes the realization that starting one's business and building that business require different skill sets. This interactive discussion will include tips on starting and marketing your freelance business, from building a website, using social media platforms, and selling your “brand.” The discussion is most relevant for those who have recently made the transition from science to medical writing. Anita Misra-Press, Freelance Medical Writer, Portland, OR
T-11 • From Benchtop to Desktop: How to Effectively Transition from a Scientist to a Medical Writer At this roundtable session, we will discuss opportunities for scientists in medical writing. The discussion will focus on how to determine whether medical writing is right for you, how to translate skills and experiences learned as a scientist into medical writing, how to develop a portfolio of writing samples, and how AMWA membership can help you. Participants will be encouraged to share their experiences with transitioning into medical writing. Ruwaida Vakil, MS, Owner, ProMed Write LLC, Somerset, NJ
T-12 • 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 from the Web 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 N. Palmer, PhD, ELS, Scientific Publications, Texas Heart Institute, Houston, TX
T-13 • How to Get Started in the International Medical Editing Game—and Win At this roundtable discussion, we will address issues, fears, and challenges facing medical editors working with authors who use English as a second language (ESL). Specific topics include marketing yourself in foreign countries; working with Asian medical editing companies; expectations ESL authors have of their editors; and how much to charge for your services. William R. Brown, MD, Emeritus Professor of Medicine, University of Colorado School of Medicine, Denver, CO; Director, International Medical Editing Service, LLC
T-14 • How to Know When the Price Is Right: Pricing for Your Writing Business Pricing is a big challenge for most freelance medical communicators. This roundtable discussion will focus on principles for pricing that reflect the value that you offer, ways to make friends with your discomfort around pricing, and action steps to adjust your pricing and increase your business income. Ursula Jorch, MSc, Med, President, Work Alchemy/Jorch Consulting Inc, Toronto, Ontario
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Full Program Schedule • THURSday T-15 • HTAs and AMCP Dossiers: Find out What They Are in Five Easy Steps! Have you heard the terms HTA and AMCP dossier but weren't quite sure what they meant? Find out by attending this roundtable discussion. You will learn what these documents are, who requests them, how are they used, what kind of information they contain, and how the development process compares with writing a scientific publication. Come join us to learn about the brave new world of writing payer-related documents! Linda L. Rice, PhD, Medical Writing Senior Manager, Amgen Inc., Boise, ID
T-16 • It's Just Business: How and When to Fire a Client While no one likes being fired (or being the one who has to fire employees or contractors), it's a part of business. This roundtable will discuss some reasons why it's acceptable to fire your client, as well as how to do it without burning a bridge. Examples of what have and have not worked will be provided. Bring your questions and examples for the group to discuss. This roundtable is offered again on Saturday. Michelle Dalton, ELS, Founder, Dalton & Associates, Reading, PA
T-17 • Managing Medical Writers Remotely Many medical writers work successfully from home, but the physical distance can sometimes be a challenge in maintaining healthy business relationships with their managers and their project teams. At this roundtable, we will discuss the challenges managers frequently encounter with medical writers who work remotely and ways to successfully integrate, manage, and develop such workers.
of communication and techniques that may help deal with difficult personalities. This roundtable is offered again on Saturday. Margaret Kinyanjui, Research Communications Officer, University Health Network, Toronto, ON
T-19 • Mastering the Medical/Legal/Regulatory Review and Approval Process If you are writing sales training or marketing materials for a pharmaceutical, biotech, or medical device company, chances are your documents will be reviewed by the company’s medical/legal/regulatory (MLR) committee. This discussion will provide an overview of the review process, present examples of electronic systems used to streamline this process, and examine the annotation requirements of deliverables and accompanying references to achieve a flawless review and successful approval. Catherine Champagne, PhD, Medical Science Writer/Editor, Education & Training Systems International, Chapel Hill, NC
T-20 • Permission Granted! Copyright Compliance and Permission Requests This roundtable will provide the basic background on US copyright law to help medical communicators identify, address, or question (if necessary) the appropriate use of copyrighted material in client deliverables. Participants will be able to share best practices for obtaining permissions and discuss any problems they currently have or have overcome related to the ever-changing copyright enviroment and permissions. Tabatha L. Cannata, Editorial Manager, Envision Pharma Group, Southport, CT
Caryl L. Burke, MS, PMP, Medical Writer, Medpace, Cincinnati, OH
T-18 • Managing Multiple Personalities in the Face of a Deadline Dealing with difficult personalities when collaborating on medical communication projects can be challenging. Some team members ignore internal deadlines while others pay little regard to the needs and contributions of other team members. Having the right management and communication skills can be invaluable when dealing with such personalities. In this roundtable discussion, we will discuss different styles
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T-21 • Priority Management: Being a Professional and a Parent This roundtable will be a discussion for medical writers who either have children or are planning to have children. There is no “best practice” for achieving a balance, but finding a working solution for each family is a must. This roundtable will be a lively discussion about finding balance (or not), work style issues, childcare, dealing with sick days or snow days, and other pertinent topics to achieve work-life balance. Shanna J. McClennen, PhD, Freelance Medical Writer, Needham, MA
AMWA’s 74th Annual Conference
Full Program Schedule • THURSday T-22 • The Pros and Cons of Specializing within Medical Communication How can medical communicators be most effective: by specializing in a narrow range of therapeutic areas or document types, or by being able to take on a wide range of projects? Which approach is best for career development? An experienced freelance writer and editor who still struggles with this issue will lead a discussion of the pros and cons of each approach. Ideally, we will get perspectives from a wide range of participants, including experienced writers and those just starting out, generalists and those who specialize, freelances and employees, and those who hire others. This roundtable is offered again on Saturday. Naomi L. Ruff, PhD, ELS, Principal, RuffDraft Communications LLC, Duluth, MN
T-23 • Quality Control Feedback on Submission Documents At this roundtable, we will discuss what quality control is, how it is performed, what we look for, what we find, and the most problematic areas in submission documents. We will also talk about why these areas are problematic, steps to help prevent these problems in future documents, and new innovations being explored. Michael C. Smith, Senior Quality Control Specialist, Sanofi, Bridgewater, NJ
T-24 • 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. Albert Y. Rhee, PhD, Medical Writing Manager, Amgen Inc., Thousand Oaks, CA
T-25 • Social Media: It's On and Twitter Is Hot! What Are You Waiting For? Something pretty remarkable happened on the Web in 2013. Social media overtook porn as the number-one activity conducted on the Web. Social channels are clearly a mainstream form of communication that opens medical and science communicators to entirely new audiences. Twitter in particular has been a great platform for many. Let's talk about what's keep-
ing you from joining the conversation if you haven't started or, if you haven't found your groove with it yet, let's figure it out. Larry Lynam, MA, Principal / Writer and Facilitator, The Lynam Group, Coral Springs, FL
T-26 • Standard Operating Procedures for Clinical Scientific Publications The development of clinical scientific publications, from initial concept to journal submission, requires effective collaboration of many stakeholders. Authors and industry sponsors can align their publication development processes with current guidelines and best practices by establishing standard operating procedures (SOPs). We will discuss why it’s important to have a publication SOP and the best practices for developing it. Julie R. L. Wang, DPM, Medical Writing Senior Manager, Amgen Inc., Thousand Oaks, CA
T-27 • Take It to the Next Level: Career Planning For Freelances As a freelance, have you ever wondered, where is my career going? What's next? A freelance medical writer's career unfolds in distinct stages, with unique professional opportunities at each stage, from landing your first client to becoming a thought leader. Your marketing and pricing strategies should be tailored accordingly. This roundtable is designed for freelances at every career level who want to learn and share strategies about how to maximize current opportunities and “take it to the next level” professionally. This roundtable is offered again on Saturday. Ann M. Volk, MA, Freelance Medical Writer, Volk Medical Communications, Dover, DE
T-28 • The 10 Most Important Strategies for Freelance Success Join this roundtable to learn about 10 critical topics from the perspective of a medical writer/editor with 20 years of experience as an independent contractor. Our discussion will address such issues as maintaining your business image, enhancing your skills, investing in the business, setting rates, networking, managing projects, advocating for yourself, analyzing your business practices, understanding legal and tax issues, and
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Full Program Schedule • THURSday coping with difficult clients, among others. This discussion is appropriate for both new freelances who are unsure of what is involved and long-term freelances who may want a different perspective. This roundtable is offered again on Saturday. Laura J. Ninger, ELS, President, Ninger Medical Communications, LLC, Rutherford, NJ
T-29 • What’s Your Problem? Problem-Solving Discussion on Editing Bring your most challenging problems in editing and get help in solving them from an expert in editing and other colleagues. Facilitator TBD
T-30 • What’s Your Problem? Problem-Solving Discussion on Writing for Lay Audiences Bring your most challenging problems in writing for lay audiences and get help in solving them from a veteran plain language writer and other colleagues. Sharon Nancekivell, MA, Freelance, Guelph, Ontario
T-31 • Write Winning Stories to Educate Consumers on How to Navigate the Health Care System with Confidence Many consumers feel like the health care system is a complicated maze. Because of higher insurance premiums and increasing deductibles, knowledge about the system can help consumers gain control. As medical writers, we can help speed up their education. At this roundtable discussion, we will discuss how to use personal stories to create awareness about a larger health care issue and empower consumers to know how to choose their best next turn.
accurately than they can. This roundtable discussion will focus on the future of medical writing and how we can adapt and thrive in the technology age. Jodi M. Pollock, Principal Medical Writer, Inventiv Health Clinical, Apex, NC
T-33 • Writing for the Medical Device Industry Participants will discuss segueing into writing about medical devices. The discussion will focus on the key differences between writing for medical devices versus drugs and biologics, opportunities for medical writers in the device industry, jurisdictional distinctions between the governing regulatory bodies, and strategies for obtaining job leads. This roundtable is offered again on Saturday. Scott C. Thompson, ELS, Principal Medical Writer, Medtronic, Memphis, TN
T-34 • Writing for Regulatory Submissions: Getting Started and Finishing Well When preparing regulatory documents such as protocols or clinical study reports that will ultimately be submitted to regulatory authorities, aside from the basic fundamental principles of clear medical writing and adherence to the rules governing clinical trial documentation, every Medical Writer should be armed with certain fundamental tools and be familiar with those processes that will ultimately lead to a high quality final deliverable. The less experienced Medical Writer will take away from this discussion what is needed to get started at the beginning of the writing project, essential quality control principles, and basic document management techniques. Michael L. Jones, MS, Former Director of Medical Writing at TKL Research, Rochelle Park, NJ
Randi Redmond Oster, MBA, 2014 Eric Martin Award Winner
T-32 • Writers Beware: Are Droids Taking Our Jobs? A Discussion on the Changing Way our Medical Documents may be Written Companies are currently developing software-driven materials and converting data, such as statistics and financial reports, into articles that appear like real humans wrote them. As the software gets better, it is predicted that writers will be replaced by software that can write something faster and more
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T-35 • Writing Science for Children and Young Adults This roundtable discussion will address the potential of writing science and health articles for children and young adults. We will first explore childhood development and the suitability of topics for each age group. We will then focus on some practical aspects of writing, marketing, and selling to such markets as books, magazines, and other areas. Evelyn B. Kelly, PhD Kelly Communications, Ocala, FL
AMWA’s 74th Annual Conference
Full Program Schedule • THURSday T-36 • You Are Not Alone! Creative Strategies in Sharing Work for Mutual Benefit Find yourself spending too much time on drudgery and no time or energy left for doing your best work? Using up all your time and energy on tasks that are boring, repetitive, and meaningless? Not the best use of your time? Don't get mad, get support! Participants will brainstorm how to get help, possible resources, and the pros and cons. This roundtable is offered again on Saturday (with a different leader). Suzanne R. Canada, PhD, Owner and Lead Medical Writer, Tanager Medical Writing LLC, Union City, CA
T-37 • 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. Plan on discussing your ideas and experience. Arlene Kray, PharmD, PhD, inVentiv Health Clinical, Pittsburgh, PA
9:00–10:30 AM Opening Session This session features a welcome from AMWA President Brian Bass, the presentation of the President’s Award, and the McGovern Medal Award Address, “Too Much of the Wrong Kind of Health News,” by Gary Schwitzer, Publisher of HealthNewsReview.org and Adjunct Associate Professor, University of Minnesota School of Public Health.
10:30–11:00 AM Sponsored Beverage Break in the Exhibit Hall
10:30 AM–4:00 PM Exhibit Hall open Stop by to meet with exhibitors and to browse the posters. Look for onsite schedules of demos by exhibitors and other presenters, including AMWA staff and volunteers describing
how to become a workshop leader and how to prepare for the first Medical Writing Certification examination. AMWA Community Lounge and Demos
11:00 AM–12:00 PM OS-01 • Advanced Client Relations: Asking the Tough Questions to Get What You Need [Freelance] Paralyzed by the “money talk”? Feel like you’re on a treadmill of urgent deadlines? Struggling with clients with 60- or 90-day payment terms? As the Rolling Stones once said, you can’t always get what you want, but if you try sometimes you might find you get what you need. In this session, you will learn some common pain points in the client relationship (hint: you’re not alone!), how to figure out what you need and ask for it (everything is negotiable), and how to stand your ground against that 500-pound gorilla of a client (don’t let yourself be bullied). Alisa Bonsignore, Writer and Strategist, Clarifying Complex Ideas, Pleasanton, CA
OS-02 • Hands On: Applied Search Engine Optimization (SEO) for the Medical Writer [Technology/Social Media] Writing accurate, informative content isn’t enough – to be truly successful in today’s digital landscape, an accurate understanding of how search works and skills in Google Analytics are what will take a great medical writer to the next level. Knowledge of keyword data, search forecasting, search trends, and general SEO tips can help medical writers rank on search engines. Through an overview of search algorithms and a hands-on Google Analytics session, learn how to be a medical writer in the digital age! Bring your laptop. Rachel Meyer, Director of Creative Content & SEO Analyst, Medical Marketing Solutions, Mesa, AZ
OS-03 • Evolution and Expansion of ICH [Regulatory] The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 and has published a series of guidelines which have contributed to global develop-
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Full Program Schedule • THURSday ment of drugs to ensure their quality, safety, and efficacy. Use of ICH guidelines has expanded to countries beyond the ICH founding members to BRIC countries, South Korea, Taiwan, Singapore, and the African Region. As a result, these countries have been gaining importance in promulgating ICH guidelines. The Global Cooperation Group, subcommittee to the Steering Committee of the ICH, with representatives from regional harmonization initiatives, has also facilitated input in drafting the guidelines to promote wider implementation. These activities serve to increase the transparency of the ICH process. With today’s globalization of the pharmaceutical industry, it is important for medical communicators in this industry to understand how ICH activity is being advanced and promoted on an increasingly global platform. Justina A. Molzon, MS, Pharm, JD, Associate Director, International Program, Office of Strategic Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
OS-04 • Organ on a Chip and Other Exciting New Advances in Nonanimal Biotechnology [Health and Medicine] New technologies, such as Organs on a Chip and computer simulations of the heart, show great promise for developing new therapies, testing chemicals, and reducing the use of animals for biomedical research. Experts in the field will describe the latest in nonanimal alternatives in biomedical research. Attendees will have an opportunity to learn about these exciting new techniques, how to write about them, and what to keep an eye out for in the future. Sarah Cavanaugh, PhD, Medical Research Specialist, Physicians Committee for Responsible Medicine, Washington, DC Coeli Lopes PhD, University of Rochester, West Henrietta, NY Martin L. Stephens, PhD, Johns Hopkins Center for Alternatives to Animal Testing, Baltimore, MD
OS-05 • Hands On: Unleashing the Full Potential of Microsoft Word [Technology/Social Media] Microsoft Word is an important tool in the medical writer’s toolbox that can save time and improve documents. In this session, you will become familiar with key settings and features in Word that are important for medical writing documents. You will learn about styles, tables, cross-references, and more us-
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ing example documents. The demonstration will also highlight advanced features, such as searches with wildcards and formatting field-codes. Bring your questions, challenges, and concerns. This session is intended for Microsoft Word 2010 users of all levels, but a basic proficiency is assumed. Bring your laptop. Natalie R. Herr, PhD, Medical Writer, Whitsell Innovations, Chapel Hill, NC
12:15–1:30 PM AMWA Workshop Leader Lunch (by invitation) AMWA recognizes the valuable role that workshop leaders play in the success of every annual conference. In appreciation of their contribution, current AMWA workshop leaders will have the opportunity to network and hear about on AMWA’s education-related activities at this special lunch event.
12:15–1:45 PM Lunch in the Exhibit Hall (included with registration fee, pre-registration required)
2:00–3:30 PM
OS-06 • Breaking In: How to Get Your Start in Regulatory Medical Writing [Professional Development] If you’re new to regulatory medical writing and looking for a way to break in, or simply at the beginning of your career and trying to decide how to shape your career, this is the session for you. Gain invaluable insight from industry professionals about how to get your start in and make your mark on the field. Dandan Zhu, Principal Consultant, Real Exec, Real Staffing Group, New York, NY Craig Heyward, Head of Contract Regulatory Medical Writing Recruitment, Real Staffing Group, New York, NY Barbara Snyder, MA, Senior Director, Medical & Scientific Communication, Onconova Therapeutics, Inc., Newton, PA
OS-07 • 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 session first. We’ll introduce the
AMWA’s 74th Annual Conference
Full Program Schedule • THURSday Center for Devices and Radiological Health (CDRH), and compare and contrast how FDA regulates drugs, devices, and diagnostics, with the goal of inspiring medical writers to think outside the pharmaceutical industry box.
within the marketplace that are or may be unfavorable to their business). We'll also discuss marketing strategies and tactics to consider based on the SWOT results.
Jeanne K. McAdara-Berkowitz, PhD, Principal, Biolexica LLC, Longmont, CO
Cyndy L. Kryder, CCC-Sp, Medical Communications Specialist, Phoenixville, PA
Tim Peoples, MA, ELS, CMPP, Medical Writing Manager, Amgen Inc, Thousand Oaks, CA Felicia R. Cochran, PhD, Principal Clinical Evidence Specialist, Medtronic Neuromodulation, Minneapolis, MN Cynthia Carr, PhD, Senior Medical Writer, Ventana Medical Systems, Inc, Tuscon, AZ
OS-08 • Scope of Medical Communication [Professional Development] This session is designed for those who want to learn about the wide range of settings for medical writers. The panel features medical writers and editors with decades of experience in their specialty or setting. Learn about the opportunities in various 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. Jennifer Grodberg, PhD, RAC, Independent Regulatory Consultant, Carlsbad, CA Marianne Mallia, ELS, Manager and Senior Medical Writer, Texas Heart Institute, Houston, TX Darlene Grzegorski, MS, Senior Medical Writer, Educational Resource Systems, Inc., Red Bank, NJ
OS-09 • Use a SWOT Analysis to Rejuvenate Your Career and Better Market Your Business [Freelance] Whether novice or pro, freelances frequently wonder whether their medical communications careers are headed in the right direction. In this session, two seasoned freelances with more than 40 years of collective experience will show attendees how to use a simple tool—the SWOT analysis—to refocus or redirect and rejuvenate their freelance business and better market themselves. We'll include exercises to guide participants in identifying strengths (professional/personal characteristics that give them a competitive advantage), weaknesses (professional/ personal characteristics that give them a competitive disadvantage), opportunities (conditions within the marketplace that are or may be favorable to their business), and threats (conditions
Brian G. Bass, President, Bass Global, Inc., Robbinsville, NJ
2:00–4:45 PM IS-01 • Intensive Seminar: How to Write and Design Online Health Content Consumers Will Use [Writing/Editing] (Ticketed event, with additional fee.) About 80% of Internet users have searched for health information online. And one in three cell phone owners have used their phone to look for health information. So how do we make online content accessible to and useful for everyone, including people with limited health literacy skills? We’ll discuss the practical implications and challenges of taking a “universal precautions” approach to writing health content that consumers find both engaging and comprehensible. We’ll also talk about writing for behavior change, including how to give people actionable information they need to make changes for better health. You’ll learn about best practices of user-centered design that apply to medical writing and discover specific strategies for improving the clarity and usability of online health information. Kat Good-Schiff, MFA, Senior Health Writer, CommunicateHealth, Inc., Northampton, MA Amy Behrens, MS, Senior Editor, CommunicateHealth, Inc., Northampton, MA Mary Ann Petti, MPH, CHES, User Experience Specialist, CommunicateHealth, Inc., Northampton, MA
2:00–5:00 PM WS-01 • Microediting (ADV) #717 [Writing/Editing] 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). To register for this workshop, it is recommended that you have already taken English Usage and Abusage, Punctuation for Clarity and Style, Sentence Structure and Patterns, and Tables and Graphs, or have at least 3 years of experience in manuscript editing. APPROXIMATE HOMEWORK TIME: 6 HOURS. Elliott Churchill, MS, MA, President, A World of Words, Tucker, GA
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Full Program Schedule • THURSday WS-02 • Reporting Randomized Trials in Science Journals (ADV) #719 [Writing/Editing] This workshop is designed for experienced medical writers who want to know how to report randomized trials and clinical research studies with a high degree of sophistication. The form and function of each component of the research article will be reviewed; however, emphasis will be placed on how to report all aspects of randomized controlled trials. Participants will practice applying the CONSORT Guidelines to reporting specific aspects of study design, research activities, and outcomes. APPROXIMATE HOMEWORK TIME: 3 HOURS.
WS-05 • Sentence Structure and Patterns (ES/G) #2009 [Writing/Editing] 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.
Tom Lang, MA, Principal, Tom Lang Communications and Training International, Kirkland, WA
WS-06 • Statistics for Medical Writers and Editors (ES/G/SG) #2010 [Relevant Skills] 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.
WS-03 • Current Trends in Drug Regulations (ADV) #728 [Regulatory] Pharmaceutical developers must anticipate future regulations and comply with newly effective regulations, while designing and implementing high-quality drug development programs. This workshop provides a forum for workshop leaders and participants to discuss in detail recent and future regulatory changes (eg, FDA's modified requirements for structured benefit-risk assessment and risk evaluation and management strategies) and how these changes impact drug development. Participants will discuss how they and their companies have been affected by, and made accommodations for, these developments. The homework assignment requires each participant to produce a short PowerPoint presentation on a regulatory change impacting pharmaceutical development and present it during the workshop. APPROXIMATE HOMEWORK TIME: 4-5 HOURS. Aaron Bernstein, Director Medical Writing, Actavis, Inc, Rockaway, NJ
WS-04 • Elements of Medical Terminology (ES/G/SG) #2005 [Writing/Editing] 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 components. APPROXIMATE HOMEWORK TIME: 3 HOURS. Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX
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Michael Lewis Schneir, MS, PhD., Professor, Ostrow School of Dentistry of University of Southern California, Los Angeles, CA
Bart Harvey, MD, PhD, Associate Professor, Dalla Lana School of Public Health, University of Toronto, Ontario
WS-07 • Public Relations Materials and Techniques (B/ FL/PRAM) #2508 [PR/Marketing/Advertising] Novices in public relations will learn how to develop communication goals and strategies, identify and target the audience, and determine the most effective methods of communicating with that audience. The workshop leader will cover the basics of writing press releases, features, tips, and public announcements. Emphasis will be on low-budget, creative projects, with examples from health care and medicine. APPROXIMATE HOMEWORK TIME: 2–3 HOURS. Melanie Fridl Ross, MSJ, ELS, Chief Communications Officer, University of Florida Health, Gainesville, FL
WS-08 • Ethical Standards in Medical Publication (CP/EW/PH) #3004 [Ethics] This workshop is required for individuals working to earn the Composition and Publication specialty certificate. In this
AMWA’s 74th Annual Conference
Full Program Schedule • THURSday 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. Andrea R. Gwosdow, PhD, President, Gwosdow Associates Science Consultants, Arlington, MA Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach, VA
WS-09 • Proofreading: Strategy for Document Quality Control (CP/EW) #3013 [Relevant Skills] 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, Nashville, TN
WS-10 • Drug Interactions (SM/EW/PH/SDT) #3508 [Health and Medicine] 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, CMPP, Envision Pharma Group, Southport, CT
WS-11 • Introduction to the Cardiovascular System (SM/SBS) #3515 [Health and Medicine] This workshop is designed for those without a science background. Topics covered will include the basics of the structure and function (normal anatomy and physiology) of the cardiovascular system, including the heart, blood vessels, and blood itself. What roles does the circulatory system play in the body? How does blood circulate, and why is that important? How does the heart do its job? What is blood's function, and what is it made of? Additional topics include heart sounds, the electrocardiogram, and blood pressure. Although certain conditions of the cardiovascular system will be mentioned, this workshop does not focus on disease processes or pathology. APPROXIMATE HOMEWORK TIME: 3 HOURS. Susan E. Aiello, DVM, ELS, Editor-in-Chief, The Merck Veterinary Manual, Merck & Co., Inc., Whitehouse Station, NJ NEW
WS-12 • Introduction to Basic Bacteriology (SM) #3525 [Health and Medicine] This workshop is intended for medical writers and editors who want to improve or refresh their understanding of basic principles of bacteriology. The first half of the workshop will be an overview of prokaryotic classification, identification, cell structure, and replication. The second half will focus on examples of clinically important bacteria (from beneficial flora in the gut to opportunistic pathogens responsible for a variety of diseases), effects of bacterial toxins, and antimicrobial agents and antibiotics (including mechanisms of antibiotic resistance). We will also introduce the concept of bacterial biofilms and how they relate to biomedical implants. This workshop is appropriate for people who write for the public or for medical and scientific readers. While there is no prerequisite, previous background or some coursework in basic cell biology or molecular biology will be useful. APPROXIMATELY HOMEWORK TIME: 3 HOURS Thomas Gegeny, MS, ELS, Envision Pharma Group, Southport, CT
Rebecca Jarvis, PhD, Envision Pharma Group, Southport, CT
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Full Program Schedule • THURSday WS-13 • The Electronic Common Technical Document (RR/PH) #4004 [Regulatory] This workshop is appropriate for regulatory/medical writers who have minimal or moderate experience in preparing documents for inclusion in a pharmaceutical drug application submitted electronically to a regulatory body in the electronic Common Technical Document (eCTD) format. The lecture/ demonstration format will allow for hands-on exercises and ample opportunity for participant questions and discussion. The workshop leader will focus on what writers need to know in order to prepare regulatory documents for inclusion in an eCTD-based drug application such as the Investigational New Drug Application (IND), Biologics License Application (BLA), or New Drug Application (NDA). Discussion topics will include the rationale, structure, and key features of the eCTD; associated global and US regulations, guidances, andguidelines; and best practices for writers on an eCTD-based submission team. Please note that this workshop will not address technical aspects of assembling an eCTD for electronic submission. APPROXIMATE HOMEWORK TIME: 1.5-3 HOURS. Nancy R. Katz, Ph.D., President & Principal Medical Writing Consultant, Illyria Consulting Group, Inc., Soda Springs,CA
WS-14 • Summarizing Clinical Efficacy Data for an NDA (RR) #4013 [Regulatory] 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 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 H. Adams, PharmD, PhD, President, MH Adams & Associates, Inc., Davie, FL
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Peggy Boe, RN, Principal and Founder, Nightingale Medical Writing, LLC, Hampstead, NC Thomas Schindler, PhD, Head Medical Writing Europe, Boehringer-Ingelheim Pharma GmbH & Co KG, Biberach, Germany
WS-15 • Clinical Study Report Writing: From Tables, Listings, and Graphs to Text (RR) #4019 [Regulatory] 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 of Regulatory Documentation, Hoffmann La-Roche Ltd., Toronto, Ontario
WS-16 • Fundamentals of Ethics and Practical Applications of Clinical Research (RR) #4020 [Regulatory] Ethical considerations associated with conducting clinical research will be explored in this workshop intended for medical writers, editors, and researchers with some experience/familiarity with regulated therapeutic development activities.The workshop will consist of short presentations on relevant ethical issues with respect to therapeutic (drug, device, vaccine) clinical trials and group discussions on major ethical considerations of some case studies. Topics include the importance of ethics in good clinical practice (GCP), the informed consent process and the challenges that may arise in developing countries, the infrastructure of ethics committees, and data safety monitoring committees. Throughout, the workshop will focus on the central ethical issue in clinical study conduct: to ensure subject safety and well-being. (NOTE: This workshop or Ethics of Communicating Regulated Drug Development Activities is required to complete the Regulatory and Research specialty
AMWA’s 74th Annual Conference
Full Program Schedule • THURSDAY certificate.) APPROXIMATE HOMEWORK TIME: 2 HOURS. Art Gertel, MedSciComm, LLC, Lebanon, NJ
3:00–4:00 PM Sponsored Beverage Break in the Exhibit Hall
4:00–5:00 PM OS-10 • Acing Your Advisory Boards, Redux: From Content Developer to Meeting Manager [Relevant Skills] Medical writers are often called on to participate in advisory board meetings, primarily to develop content (eg, speakers’ slides). This session will push participants to take it one step further: to become meeting managers, instead of just content developers. The presenter—an advisory board veteran with 7 years’ experience in running meetings—will provide a framework for successful advisory board management, laying the groundwork for long-term relationships with one’s pharma client and the advisors one works with. Attendees will learn the principles of agenda development, how to create discussion questions that elicit candid answers, and facilitation techniques. Jose Miguel B. Curameng, MD, Head of Editorial, MIMS (Hong Kong) Limited, Hong Kong
OS-11 • How To: Improving the Skills of Grant Proposal Writers [Grants] This how-to session is for anyone involved in the development of medical research grant proposals, and particularly those who teach (or aspire to teach!) proposal writing in their institutions. Two seasoned grant writing instructors will share their qualitative observations of audience (grant reviewers’) expectations for the genre, and the prevalent proposal writing issues experienced by early-stage medical researchers. They will also outline how they are using this information to purposefully adapt their workshop-based teaching approach. The discussion will include sample instructional materials to help proposal writers–and the medical editors who support them– become proficient in this complex writing genre. Kimberly A. Thomas-Pollei, Ph.D., Lecturer, University of Minnesota, Minneapolis, MN Anne Marie Weber-Main, Associate Professor of Medicine, University of Minnesota, Minneapolis, MN
OS-12 • How to Tame Your Timeline Dragons: Project Management and Negotiation for Medical Writers [Relevant Skills] Do you find yourself stressed to excess with impossible deadlines? Frequently giving up evenings and weekends? This situation can lead to resentment and frustration that can hurt your workplace relationships and overall job satisfaction. This session will discuss ways to manage timelines so you can do your best work. Suzanne R. Canada, PhD, Owner and Lead Medical Writer, Tanager Medical Writing LLC, Union City, CA
OS-13 • The Value Proposition Social Media in a Compliant Environment—Tweet Away? [Technology/Social Media] Social Media, in particular Twitter, is a growing medium for exchange and interaction of ideas, particularly between health care consumers and industry. The use of Twitter has been only tentatively embraced by industry but has been overwhelmingly dominated by patients, advocacy groups, and, to a lesser extent, researchers. Many industry members are finding that non-involvement in Twitter means that the “conversations” will take place without them. The FDA, though very active on Twitter, had been relatively silent on the mechanics of submission of social media interactions until a draft guidance was issued in January 2014. This presentation will discuss how to tweet in a compliant manner and how to apply the concepts of the FDA draft guidance to social media interactions. Robin Whitsell, BPh, President,Whitsell Innovations, Inc, Chapel Hill, NC
5:00–6:00 PM Exhibit Hall open Networking Reception in the Exhibit Hall (cash bar ) 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.
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Full Program Schedule • friday FRIDAY, October 10
Successfully Onboarding a Medical Writer: Filling the Gap between Orientation and Integration
7:00 AM–4:00 PM Conference Registration and AMWA Information Desk open
7:30–9:00 AM Continental Breakfast with the Exhibitors and Passport Prize Awards (included with registration) Visit with the Poster Presenters in the Exhibit Hall 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. Also take advantage of this time to discuss posters with their authors. The following posters have been accepted for display. Evaluation of the 2011 CDRH Plan of Action for Implementation of 510(k) and Science Recommendations Emily E. Campbell, Graduate Student in Biomedical Writing, University of the Sciences, Philadelphia, PA
From R&D to Clinical Trials: Medical Writing Strategies for Global Teams Angela N. Johnson, BFA, MSE, PMP, Senior PB Clinical Writer, GE Healthcare, Waukesha, WI Catherine Cadogan, BS, Senior PB Clinical Writer, GE Healthcare, Waukesha, WI Yolanda Wang, PhD, Senior PB Clinical Writer, GE Healthcare, Beijing, China
Hey RNA – Writers Don’t Like Transcription Errors Either Linda A. Landon, PhD, ELS, President, Research Communiqué, Jefferson City, MO
Meta-Analyses and Systematic Reviews—the Literature Reporting Panaceas in an Evidence-Based World? Karen Sedacki, Senior Medical/Technical Writer, MicroPort Orthopedics, Arlington, TN
Streamlined Approach for Preparing Multiple CountrySpecific CMC-Dossier Sections to Support Worldwide Clinical Trials R. S. Robin Robinett, PhD, Director, Merck & Co., Inc., West Point, PA
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Yeshi Mikyas, PhD, ELS, CMPP, Publications Lead, Baxter Healthcare, Thousand Oaks, CA Caryl Burke, MS, PMP, Medical Writer, Medpace, Cincinnati, OH
A Systematic Process to Creating High-Quality Developmental Safety Update Reports Roshawn Watson, PharmD, PhD, Senior Regulatory Writer, Synchrogenix Information Strategies, Cambridge, MA
Writer/Editor Relationship: Reflections on Current Practice Charlotte A. Kenreigh, PharmD, CMPP, Principal Medical Writer, Envision Pharma Group, Southport, CT Linda T. Wagner, PharmD, CMPP, Principal Medical Writer, Envision Pharma Group, Southport, CT Tabatha L. Cannata, Editorial Manager, Editorial Solutions, Envision Pharma Group, Southport, CT Elizabeth Wassmer, Editor, Editorial Solutions, Envision Pharma Group, Southport, CT
You Need Help with What? Understanding the European Clinical Evaluation Report (CER) Laurel E. Riemann, PharmD, President, PharmIAD, Inc, Savannah, GA James B. Lutz, MS, CCRA, President, Lutz Consulting, LLC, Buellton, CA
Becoming an AMWA Workshop Leader: the How-to Guide Tom Gegeny, MS, ELS; Marianne Mallia, ELS; David Clemow, PhD; James Cozzarin, ELS; Barbara Gastel, MD, MPH; Bart Harvey, MD, PhD; Sue Hudson, and Karen Klein, MA, ELS; on behalf of the 2013–2014 Medical Writing Certification Commission
Getting Ready for the AMWA Medical Writing Certification Examination The Medical Writing Certification Commission of AMWA
7:30 AM–12:00 PM AMWA Community Lounge and Demos
7:30 AM–2:00 PM Exhibit Hall open, Posters on display
AMWA’s 74th Annual Conference
Full Program Schedule • friday 9:00–10:00 AM OS-14 • Hands On: Can Google Hangout On Air Revolutionize Your Professional Life? [Technology/ Social Media] One part GoToMeeting, one part Skype, and one part Star Trek, Google Hangout On Air (GHOA) is not just another online communication tool. With easy-to-use functionality, no-fuss crosstalk with YouTube, and user-friendly plugins that allow for real-time discussion with an audience of your peers (did we mention the platform is FREE?!), GHOA can be used for a number of business-related purposes. In this session, you'll get a hands-on demonstration of how GHOA works and insight into ways it can be utilized in the professional arena. Bring your laptop or computer tablet (with an established Gmail of Google+ account) if you wish to participate in the hands-on demonstration. Scott L. Kober, MBA, CCMEP, Senior Director, Educational Strategy, Institute for Continuing Healthcare Education, Philadelphia, PA April A. Reynolds, Freelance Writer, Write/Correct, Inc., San Diego, CA
OS-15 • Conceptualizing and Writing in IMRAD Style (Introduction, Methods & Materials, Results, and Discussion) [Writing/Editing] The IMRAD process involves thinking and writing in an organized and logical series of steps and is one of the fundamental skills a medical writer should possess. Communicating scientific and medical concepts using the IMRAD approach is often an expectation of medical writers—even if employers are unaware of the fact that they’re using that process by name. This session will cover the construction of effective IMRADstyle documents such as journal articles, meeting posters, grant proposals, and PowerPoint presentations. Kelleen N. Flaherty, MS, Assistant Professor, Biomedical Writing Programs, University of the Sciences in Philadelphia, Philadelphia, PA
OS-16 • How To: Crossing the Finish Line! Best Practices in Finalizing Regulatory Documents [Regulatory] Incorporating the last reviewer comment into your regulatory document is a moment for celebration, but the document is not done yet. Document finalization requires many steps, which can be simple or frustratingly slow. Attendees will learn best
practices for preparing a document for quality control review and publishing, as well as steps that writers can take to minimize the chances of having a last-minute error in content or formatting that can halt the publishing process. This interactive how-to session will include redacted examples from actual regulatory documents in various stages of finalization. Ann M. Winter-Vann, PhD, Senior Medical Writer and Consultant, Whitsell Innovations, Inc., Chapel Hill, NC
OS-17 • How to Network: a Systematic, Hands-on Approach [Professional Relationships] Many of us struggle with networking. 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). We will also cover how to approach online and social networking, lowpressure 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. Lastly participants will provide feedback to each other. Through this process, networking will become less intimidating and more approachable. Jenilyn J. Virrey, PhD, CMPP, Medical Writing Senior Manager, Amgen Inc., Thousand Oaks, CA
9:00–11:45 AM IS-02 • Intensive Seminar: Present with Ease: Insights to Improve Your Communication Effectiveness [Relevant Skills] (Ticketed event, with additional fee.) This intense and interactive seminar will provide practical tools to help you develop and deliver effective presentations, whether one-on-one or to groups. Participants will learn how to kick the PowerPoint crutch by learning to separate the written word from the spoken; apply fundamental principles of effective communication to all interpersonal communication, not just presentations; develop concise, compelling content; and answer questions clearly, concisely, and effectively. Participants will apply content development models to develop a short presentation. A number of these presentations may be delivered during the seminar. Eric Bergman, ABC, APR, MC, Author, 5 Steps to Conquer ‘Death by PowerPoint’, Pickering, Ontario
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Full Program Schedule • friday APPROXIMATE HOMEWORK TIME: 3 HOURS.
9:00 AM–12:00 PM
MaryAnn Foote, PhD, MA Foote Associates, Westlake Village, CA
WS-17 • Advanced Data Presentation: Tables, Graphs, and Charts (ADV) #701 [Relevant Skills] This workshop is intended for medical writers and editors who have at least a moderate degree of experience working with graphical displays of data. The leader 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. For background knowledge, It is highly recommended that registrants have previously attended Tables and Graphs and Statistics for Medical Writers and Editors, and either Basics of Epidemiology or Interventional and Observational Research Design. APPROXIMATE HOMEWORK TIME: 3 HOURS.
WS-20 • Basic Grammar I (ES/G) #2000 [Writing/Editing] 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. If you took Basic Grammar II & Usage for credit, you can still take this workshop for credit if you need additional grammar review. APPROXIMATE HOMEWORK TIME: 2 HOURS.
Janet Novak, PhD, Senior Editor, Memorial Sloan Kettering Cancer Center, New York, NY
Erica Goodoff, ELS, Scientific Editor, Department of Scientific Publications, The University of Texas MD Anderson Cancer Center, Houston, TX
Bart Harvey, MD, PhD, Associate Professor, Dalla Lana School of Public Health, University of Toronto, Ontario
WS-18 • Risks and Ratios (ADV) #721 [Relevant Skills] In this workshop, participants will learn about the 11 most common measures of risk, including risk, odds, and hazard ratios; absolute and relative risks and risk reductions; and effort-to-yield measures, such as the number needed to treat. We will also discuss how risk is perceived and how this perception can be manipulated to mislead. The homework involves the simple calculation of these measures of risk to teach the relationships that each represents. APPROXIMATE HOMEWORK TIME: 3 HOURS. Tom Lang, MA, Principal, Tom Lang Communications and Training International, Kirkland, WA
WS-19 • Critical Appraisal for Writers and Editors of Biomedical Research Articles (ADV) #726 [Writing/ Editing] This workshop, designed for experienced medical writers and editors, teaches participants how to interpret and report the performance characteristics of diagnostic tests in the biomedical literature. Participants will practice applying a set of detailed guidelines for reporting various test characteristics.
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Jude Richard, ELS, Senior Medical Writer, INC Research, Austin, TX
WS-21 • Essential Ethics of Medical Communication (ES) #2006 [Ethics] 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 number of real-world case studies--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, name the ethical problem in each, identify the involved stakeholders and their perspectives, debate alternative decisions, and use role-playing to present those decisions to the entire group. This workshop is suitable for both entry-level and experienced medical communicators. APPROXIMATE HOMEWORK TIME: 3 HOURS. Jill M. Shuman, MS, ELS, Managing Partner, JSA Consultants, Gloucester, MA
WS-22 • The Internet: How and Where to Find the Information You Seek (ES/EW/FL) #2012 [Technology] This slide lecture and live Internet demonstration are intended for beginning to moderately experienced Web users. After a
AMWA’s 74th Annual Conference
Full Program Schedule • friday brief review of Web browser commands and features, URLs and hyperlinks, and Internet protocols, focus will shift to the use of the Web as a research tool. The workshop leader will demonstrate the effective use of Web search engines and other resources, including specialized search sites, and will problem-solve common challenges like narrowing down search results and sorting out useful information from commercial or possibly fraudulent content. 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. APPROXIMATE HOMEWORK TIME: 3-4 HOURS. Thomas Gegeny, MS, ELS, Envision Pharma Group, Southport, CT
WS-25 • Essentials of Copyediting (CP/EW) #3003 [Writing/Editing] 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. Susan E. Aiello, DVM, ELS, Editor-in-Chief, The Merck Veterinary Manual, Merck & Co., Inc., Whitehouse Station, NJ
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WS-23 • Establishing Style: Exploring and Developing In-House Guides (ES) #2013 [Writing/Editing] Why are style guides so important at a project or team level? The larger manuals, such as the American Medical Association Manual of Style (AMA), provide comprehensive guidance to medical communicators and also direct the development of internal (ie, house) style guides. This workshop introduces distinguishing style points of the major manuals and discusses optimal content and format of a house style guide. During the workshop, participants will use different major manuals to develop a project-specific house guide. Participants should have access to at least two major style manuals (eg, Chicago Manual of Style, AMA) for the pre-course assignment. APPROXIMATE HOMEWORK TIME: 2 HOURS. Nicole Van Hoey, PharmD, Freelance, Arlington, VA Cindy W. Hamilton, PharmD, ELS, Hamilton House, Virginia Beach, VA
WS-24 • Launching a Freelance Writing Career (B/FL) #2504 [Freelance] 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.
WS-26 • Medical Journalism: From Choosing a Topic Through Polishing the Piece (CP/EW/FL) #3009 [Writing/ Editing] 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-27 • Writing Abstracts (CP/EW/PH) #3019 [Writing/ Editing] 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 Yeshi Mikyas, PhD, ELS, Senior Manager, Publications, Baxter Healthcare, Thousand Oaks, CA
Eleanor Mayfield, ELS, Principal, ELM Communications, Pittsburgh, PA
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Full Program Schedule • friday WS-28 • Basic Laboratory Methods in the Biological Sciences (SM) #3502 [Health and Medicine] 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, Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
WS-29 • Background to Writing Informed Consent Documents (RR/PH) #4000 [Regulatory] 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. Paula Fischthal, MA, Associate Director, Clinical Development, AstraZeneca Michelle Eby, Pharm.D, CCRP, Consumer Safety Officer, Food and Drug Administration
WS-30 • Summarizing Clinical Safety Data for an NDA (RR) #4014 [Regulatory] 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 highlevel 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
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generating these documents. APPROXIMATE HOMEWORK TIME: 2-3 HOURS. Marijke H. Adams, PharmD, PhD, President, MH Adams & Associates, Inc., Davie, FL Peggy Boe, RN, Principal and Founder, Nightingale Medical Writing, LLC, Hampstead, NC
WS-31 • Writing the Final Report of a Clinical Trial (RR/ PH) #4016 [Regulatory] 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. Lawrence Liberti, MS, RAC, Executive Director, CIRS-Centre for Innovation in Regulatory Science, Holland, PA Sara Ewing, BSN, RN, Accurate Biomedical Communication, LLC, Yardley, PA
WS-32 • Understanding the Principles of Kaplan-Meier Analysis (RR) #4017 [Regulatory] This workshop is intended for writers and editors who want to understand the basic principles of Kaplan-Meier analysis (survival analysis, time-to-event analysis). Participants should have some understanding of basic statistics and be familiar with terms such as mean, median, and probability. The workshop leaders will discuss the appropriate presentation of survival data and their description in text. The workshop will also entail a brief introduction to survival analyses from recent oncology trials. The presentation will be in a lecture format and include exercises. The workshop leaders will not go into details of the statistical tests used in the analysis of survival data. APPROXIMATE HOMEWORK TIME: 2-3 HOURS. Thomas Schindler, PhD, Head Medical Writing Europe, Boehringer-Ingelheim Pharma GmbH & Co KG, Biberach, Germany Sybille Eibert, PhD, Team Leader / Senior Medical Writer, BoehringerIngelheim Pharma GmbH & Co KG, Biberach, Germany
AMWA’s 74th Annual Conference
Full Program Schedule • friday 10:00–11:00 AM Sponsored Beverage Break in the Exhibit Hall
10:30–11:30 AM OS-18 • Computer Analyses of Medical Documents through Coh-Metrix [Writing/Editing] Recent advances in computational linguistics and discourse processing have made it possible to analyze naturalistic texts and conversation on multiple levels of language and discourse. This presentation reports examples of automated text analyses with Coh-Metrix (http://cohmetrix.com). Several dozen measures funnel into five major factors: narrativity (versus informational), syntactic simplicity, word concreteness, referential cohesion, and deep (causal) cohesion. Coh-Metrix can be applied to help improve brochures for the public, technical documents, advertisements, and pharmaceutical documents. Art Graesser, PhD, Psychology Department and Institute for Intelligent Systems, University of Memphis, Memphis, TN
10:30 AM–12:00 PM OS-19 • From R & D to Clinical Trials: Medical Writing Strategies for Global Teams [Regulatory] Global collaboration is increasingly important to enable both independent medical writers and those working with large companies to build a knowledge base and key relationships that facilitate effective documentation throughout lifecycles of medical device, pharmaceutical, and combination products. Join this panel of medical writers who work extensively with global teams to discuss strategies that will allow you to assess your skills and work more effectively as a medical writer in global teams. In particular, learn more about the unique technologic and interpersonal challenges and opportunities posed by interacting with global regulatory, engineering, and medical stakeholders.
OS-20 • Understanding Plagiarism and Adapting to “Checking” Technology [Ethics] As the volume of researchers who are attempting to get their medical research published continues to rise, the number of misconduct incidents is also increasing. Whether researchers decide to cut corners, blatantly plagiarize, omit attribution, or worse, publishing organizations have turned to new technology to assist with the editorial review process. Today, 80% of high impact factor journals have access to plagiarism software. All researchers, regardless of ethical behaviors, have a responsibility to review their own work and adapt to new “originality checking” technology. Join this session to better understand plagiarism; hear how leading publishers, government agencies, and research institutions are using plagiarism technology; and see how one of the most widely used technologies, iThenticate, helps medical professionals better evaluate written work before publication. Bob Creutz, Executive Director, Turnitin/iThenticate, Oakland, CA Jonathan Bailey, Author, Plagiarism Today
OS-21 • When More Senses Are Better than One [Professional Relationships] Have you ever wondered and said, "HMMM, if both the word and illustration are visual learning tools why do some people gravitate to one more than another for learning comprehension?" Have you ever wondered how in collaboration, medical writers and medical illustrators as a team can convey the information more fully for audience understanding? Participants should bring an article that is in process or published. Let us discuss how we may increase understanding of the story for our audience by working in tandem and complementing each other's strengths. Deborah K. Haines, MFA, CMI, FAMI, Medical Illustrator, University of Tennessee College of Veterinary Medicine, Knoxville, TN Delilah R. Cohn, MFA, CMI, FAMI, Principal/Owner, The Medical Illustration Studio, Nashville, TN
Angela N. Johnson, BFA, MSE, PMP, Senior PB Clinical Writer, GE Healthcare, Waukesha, WI Catherine Cadogan, Senior PB Clinical Writer, GE Healthcare, Waukesha, WI Yolanda Wang, PhD, Senior PB Clinical Writer, GE Healthcare, BeiJing, China
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Full Program Schedule • friday 12:15–1:45 PM
2:00–3:00 PM
AMWA Sablack Awards Luncheon (complimentary, advanced registration required) One of the highlights of every conference is now free for all attendees. Named after AMWA’s first executive director, Lillian Sablack, this event recognizes the outstanding service and contributions of medical communicators. Presentation of the Golden Apple Award: Scott Kober, MBA, CCMEP, chair of the 2014 Golden Apple Award Committee, will present this award for excellence in workshop leadership to Thomas Gegeny, MA, ELS. Presentation of 2014 Fellowships: 2014 Fellowship Committee chair, Barbara Snyder, MA, will present Fellowship Awards to Lori De Milto, MJ, Joanne McAndrews, PhD, and Deborah Whippen, and an honorary fellowship to Justina Molzon, MS, JD, of the US Food and Drug Administration, for significant contributions to the goals and activities of the association. Presentation of the Harold Swanberg Distinguished Service Award and Swanberg Address: Bart Harvey, PhD, 2014 Swanberg Committee chair, will present the Swanberg Distinguished Service Award, given for distinguished contributions to medical communication and the medical profession, to J. Patrick P. G. Barron, Professor Emeritus, Tokyo Medical University, and Adjunct Professor, Seoul National University Bundang Hospital, who will then present his award address, “Memories, Observations, and Predictions: the Past, Present, and Future of Medical Writing in Japan and Asia.”
2:00–2:30 PM OS-22 • Hands On: Advanced Google Techniques for Content Creation/Curation [Technology/Social Media] Who wouldn’t want to make their job easier? We may all know how to use Google for a basic search, but what most people don’t know is that, with a little bit of knowledge, you can manipulate Google to serve you the kind of search results you really need to see, making it easier to cultivate ideas, find resources, and make content creation and curation far easier than ever before! Bring your laptop or computer tablet. Rachel Meyer, Director of Creative Content & SEO Analyst, Medical Marketing Solutions, Mesa, AZ
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OS-23 • How To: Effective Scientific Presentations: a Tour Guide Approach [Relevant Skills] The fruits of scientific and medical research are like stories that deserve to be told. In this session, you will learn how to take your audience on a tour, guiding them along the way and helping them see things from your perspective. This session will introduce you to the hallmarks of a good scientific presentation and teach you methods to effectively engage the audience and hold its attention. In addition, you will learn how to tap into the potential of storytelling to convey a scientific message. Anand Devasthanam, MA, PhD Student, Roswell Park Cancer Institute, Buffalo, NY
OS-24 • How To: I Have the Abstract, How Do I Make It into a Poster? [Relevant Skills] To effectively promote and communicate results of research presented at a meeting, a poster must be organized in a clear, easy-to-read, and attractive format. This how-to session will discuss how to develop a poster from an abstract and will include tips about text, figures, and overall format to create a well-organized and attractive presentation. Michelle E. Stofa, Medical Editor and Research Communications Manager, Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE
OS-25 • How To: Make Your Message Memorable: The Power of Story [Writing/Editing] Want your message to stick? Consumers and professionals alike remember stories far better than bullet points and statistics. Readers respond not only to case studies but also to shorter and less formal encounters with the human condition, such as anecdotes, clinical vignettes, and parables. This How To session will summarize the neurobiology of why stories are so powerful, survey the role of story in culture and persuasion, identify key elements of effective storytelling, illustrate those elements with video clips, present interviewing techniques that elicit engaging stories from others, and provide opportunities to practice interviewing and storytelling in small groups. Geoffrey P. Kane, MD, MPH, Chief of Addiction Services, Brattleboro Retreat, Brattleboro, VT
AMWA’s 74th Annual Conference
Full Program Schedule • friday OS-26 • Peer-Reviewed Journals: How to Maximize the Acceptance Potential of Your Manuscript [Writing/ Editing] Getting a paper accepted by a peer-reviewed journal is one of the most difficult challenges faced by a medical writer. Unlike with other types of medical writing, you have little control on the outcome after your paper is submitted. Consequently, it is imperative that your paper be prepared in a manner that maximizes its potential for acceptance. An effective methodology will be presented that will enable medical writers to prepare a compelling manuscript, make an informed decision of which journal to select, and successfully manage the editor's decision to ultimately close the deal on publication. William S. Pietrzak, PhD, Senior Technical Writer, Biomet, Inc., Warsaw, IN
OS-27 • Cancelled
2:00–5:00 PM AMWA Community Lounge and Demos Exhibit Hall and Poster take-down
2:00–5:00 PM WS-33 • Advanced Online Searching of the Medical Literature (ADV) #707 [Technology] This advanced workshop is designed for medical communicators who wish to investigate effective strategies for accessing online informational health resources. A team approach will be used to review online assignments in class. Discussion will focus on selection of appropriate databases and on optimal searching techniques. Topics will also include selecting an online database vendor, Internet sources, and the continued development of online informational resources. To register for this workshop, it is recommended that you have at least 5 years of experience in editing or writing. APPROXIMATE HOMEWORK TIME: 3 HOURS. Joan N. Nilson, Policy Development and Research Analyst, UPMC Health Plan, Pittsburgh, PA
WS-34 • Macroediting (ADV) #713 [Writing/Editing] This workshop is for experienced editors. Participants will analyze the content and organization of a complete manuscript as
a preworkshop exercise; during the workshop, 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, Tucker, GA
WS-35 • Strategies for Improving Document Quality for Pharmaceutical Communications Managers (ADV) #722 [Writing/Editing] Improving the process of document preparation is crucial for medical writers. Discussion will include mechanisms for enhancing quality and accountability and for ensuring adequate time allowances. These are organizational issues around which a medical writing group can build policies aimed at ensuring a higher degree of accountability among those with whom they work and upon whose input they depend. This workshop is suggested for experienced medical writers who either are in a supervisory role or will soon be taking on that responsibility. APPROXIMATE HOMEWORK TIME: 2 HOURS. Art Gertel, MedSciComm, LLC, Lebanon, NJ
WS-36 • Basic Grammar II and Usage (ES/G) #2001 [Writing/Editing] 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. If you took Basic Grammar I but believe you could use a more thorough review of these topics, you can also receive credit for taking this workshop. APPROXIMATE HOMEWORK TIME: 3 HOURS. Anne Marie Weber-Main, PhD, Associate Professor of Medicine, University of Minnesota Medical School, Minneapolis, MN Loretta Bohn, Senior Editor/Writer, RTI International, Research Triangle
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Full Program Schedule • friday WS-37 • Effective Paragraphing (ES/G) #2003 [Writing/ Editing] 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. Helen E. Hodgson, PhD, Westminster College, Salt Lake City, UT
WS-38 • Tables and Graphs (ES/G) #2011 [Relevant Skills] 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. Mark D. Weiss, MA, MS, President, Apothaceutics International, Inc. Congers, NY
WS-39 • Plain Language (CP/EW) #3011 [Writing/Editing] 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. Sharon Nancekivell, MA, Freelance, Guelph, Ontario
WS-40 • Preparing CME Materials: Concepts, Strategies, and Ethical Issues (CP/EW/FL) #3012 [Continuing Education] Beginning to advanced medical writers are often involved in the preparation of educational-needs assessments, learning objectives, and content for continuing medical education
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(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 when pharmaceutical companies provide 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. Eve J. Wilson, PhD, CCMEP, Owner, MORPHOS Medical Education, Bowie, MD Marcello A. Morgan, MD, CCMEP, Senior Medical Writer, IMNE, Somerville, NJ
WS-41 • Developing Publications in Accordance with GPP2 Guidelines (CP) #3026 [Regulatory Writing] This workshop is intended for novices and moderately experienced writers and editors. The leader will describe a collaborative and transparent process for developing companysponsored 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 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, Thousand Oaks, CA
WS-42 • Basics of Molecular Biology (SM/EW/PH/SG) #3504 [Health and Medicine] 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. Hilary Graham, MA, Medical Writer, INC Research, Austin, TX
AMWA’s 74th Annual Conference
Full Program Schedule • friday WS-43 • Introduction to Cancer Pharmacology (SM) #3512 [Health and Medicine] 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 audience engagement. The workshop leader will focus primarily on elucidating the mechanisms of common cancer drugs on the market, examining the multitude of ways drugs can inhibit cancer cell growth. The workshop will be structured to highlight drugs with similar drug targets. 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: 3 HOURS. Sunil Patel, MS, Senior Drug Safety Associate, Onyx Pharmaceuticals, South San Francisco, CA
WS-44 • Basics of Epidemiology (RR/EW/PH/SG) #4001 [Health and Medicine] Designed for experienced medical writers, this combination of lecture and group exercises will be help the participants learn to interpret basic epidemiological data. The focus will be on the critical evaluation of reported medical findings and the application of epidemiological concepts to improve the participant's writing. Measures of disease occurrence, research designs, and causality 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
WS-45 • Ethics of Communicating Regulated Drug Development Activities (RR) #4006 [Regulatory] This workshop provides an overview of ethical considerations for communicating regulated drug development activities to scientists, regulatory authorities, health care providers, and others. This workshop will not address science-and-medicine issues or publication-related issues because they are addressed in other workshops. Topics relevant to regulated drug development activities include ethics in clinical and nonclinical
trials, conflicts of interest (eg, financial, scientific), authorship of regulated documents, data management and archiving, plagiarism, privileged information, and collaboration. This workshop comprises a homework assignment, an interactive lecture, and a class exercise. NOTE: This workshop or Fundamentals of Ethics and Practical Applications is required to complete the Regulatory and Research specialty certificate. APPROXIMATE HOMEWORK TIME: 2-3 HOURS. Marijke H. Adams, PharmD, PhD, President, MH Adams & Associates, Inc., Davie, FL
WS-46 • Interventional and Observational Research Design (RR/EW/PH/SG) #4007 [Regulatory] This workshop, intended for beginning medical writers who are inexperienced in clinical research design, will cover research trial designs used in the two primary 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, Former Director of Medical Writing at TKL Research, Rochelle Park, NJ Mary H. Whitman, MS, PhD, Senior Director, Medical Affairs Janssen Biotech, Inc, Spring House, PA
WS-47 • Regulatory Aspects of the Drug Development Process (RR/PH) #4010 [Regulatory] 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. Aaron Bernstein, Director Medical Writing, Actavis, Inc, Rockaway, NJ Yeshi Mikyas, PhD, ELS, Senior Manager, Publications, Baxter Healthcare, Thousand Oaks, CA
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Full Program Schedule • friday 3:00–4:00 PM Sponsored Beverage Break
3:30–5:00 PM OS-28 • How To: Advanced Microsoft Word 2010 for Windows [Technology/Social Media] 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 session, we will introduce participants to the back-end of the program—through preferences, macros, and styles—to create consistent, readable documents. Participants must bring their Windows laptops and are invited to come with both frustrations and best practices—and even a challenging document that could be worked on during the session. Through this combination of instruction, hands-on tutorial, and test driving, participants will learn how to wring the most out of MS Word to expedite their workflow and create impeccable documents. (Recommended: use of MS Word 2010 on PCs for at least 2 years; no beginners please.) Melissa Bogen, ELS, Bogen Editorial Services, Chester, NY Hope J. Lafferty, Hope Lafferty Communications, Nashville, TN
OS-29 • Dot Your Eyes, Don't Cross Them: Ophthalmology from a Medical Writer's Perspective [Health/Medicine] With the wide range of ocular diseases, new advances in treatment, and ever-more stringent regulatory requirements, basic knowledge of ophthalmology and an understanding of what is required of medical writers can yield numerous opportunities in this field. This session will provide a basic overview of ocular anatomy, pathology, and treatment, with an emphasis on medical devices. In addition, a variety of documents in this field will be presented, ranging from clinical study protocols to clinical evidence reports, and posting clinical trial information on the ClinicalTrials.gov registry. One hour session, 3:30-4:30 PM. Denise L. Sturrock, MPH, Senior Technical Writer, Abbott Medical Optics Inc, Santa Ana, CA
OS-30 • The Language of Sex and Gender: a Role for Medical Writers [Writing/Editing] “Sex,” “gender,” and related terminology and concepts are frequently conflated or misdefined in medical and scientific
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writing. In addition to being factually inaccurate, outmoded language and assumptions may obscure the medical needs of individuals, populations, and subpopulations, resulting in compromised health care and less useful data. This session will 1) review current understandings of the role of sex and gender in public health initiatives and clinical research; 2) discuss the ways in which commonly used terminology and writing habits can perpetuate misleading assumptions; and 3) equip writers to discuss sex and gender accurately and respectfully. Sandra R. Distelhorst, ELS, Senior Writer, Northwest Health Communications, Edmonds, WA Emily J. Mahan, Associate Editor, Northwest Health Communications, Edmonds, WA
OS-31 • Put on Your Own Oxygen Mask First: Getting (and Staying) Organized [Soft Topics] Establishing a healthy work/life balance was the most common challenge identified by respondents to the 2013 AMWA Needs Assessment. This open session will be a lively panel discussion about finding balance (or not); work style issues; child care; the importance of meal planning, exercise and sleep; and systems for organizing and maintaining the office, papers, files, and calendar. There is no “best practice” for achieving a healthy work/ life balance, but finding a working solution for each household is a must. Joanne M. McAndrews, PhD, Freelance Medical Writer, St. Louis, MO Shanna J. McClennen, PhD, Freelance Medical Writer, Needham, MA Teresa G. James, CPO, ASP, Certified Professional Organizer, Organize and Stage Your Home, Cordova, TN
OS-32 • Social Media: it's Not Just an Option Anymore [Technology/Social Media] Whether you’re a freelance health communicator or part of a corporate team, social media must be an essential component of your marketing strategy. Get up to speed or enhance your social media savvy in this timely, interactive panel session, which will engage participants through scenarios and role playing, exploration of actual social media “mishaps,” healthy debate, and questions and answers. You’ll get an overview of the most popular social media outlets, such as LinkedIn, Twitter, YouTube, Google+, Instagram, and Facebook, in addition to tools used to measure your social media effectiveness and
AMWA’s 74th Annual Conference
Full Program Schedule • FRIDAY/SATURday efficiency. You will also learn about best and worse practices to help ensure a successful social media experience. Felicia L. Hudson, Writer and Communications Consultant, Hudson Creative Copy, Chicago, IL Brande N. Martin, Senior Editor, College of Pathology, Northfield, IL Larry Lynam, MA, Principal / Writer and Facilitator, The Lynam Group, Coral Springs, FL
OS-33 • What Should I Charge? [Freelance] The magic behind the curtain will be revealed! What do freelances charge for projects? Are you charging too much, too little? How might overcharging or undercharging have an impact on your business? These questions and more will be answered. But don't just sit back and listen. This session will be very interactive. You might even be invited to play The Price is Right! Discussion will be guided by real-life estimating challenges and opportunities-yours, and ours. Follow this link (https://www.surveymonkey.com/s/FXFYJMH) to give us an anonymous glimpse into one of your recent projects. We don't want any proprietary or confidential information. All we ask for is a brief description of the deliverable, what you charged for it, and how that worked out for you. Come, learn, share, profit! Brian G. Bass, President, Bass Global, Inc., Robbinsville, NJ Cyndy L. Kryder, CCC-Sp, Medical Communications Specialist, Phoenixville, PA
6:00–8:00 PM Dine Arounds These popular dining out events are a great opportunity to spend some quality time with friends and colleagues outside the conference and sample the tastes of Memphis. Attendees will be able sign up onsite for a dine-around group and after dinner continue to Beale Street for the night!
SATURDAY, October 11 8:00 AM–3:00 PM Conference Registration and AMWA Information Desk Open
9:00–10:00 AM OS-34 • How To: Champagne Results on a Beer Budget—High-End Health Care Public Relations for Less [PR/Marketing] Working for health care and medical nonprofits, associations and start-ups can challenge even the most resourceful public relations pro to do more with less. This session focuses on leveraging readily available Internet tools as well as tried-andtrue techniques to perform high-level strategic and tactical work. Using Adobe Acrobat as a collaborative publishing tool, no- and low-cost news release distribution services, and free or near-free technologies will enable you—and your staff to multi-task. Sherree Geyer, Managing Partner, QuickSilver Edge, LLC, Lake Forest, CA
OS-35 • Current Controversies in Medical Writing This interactive session provides an overview of three timely topics, with ample time given for attendees to discuss each topic and ask questions. The topics include conflict of interest management; the most common problems medical writers experience, especially with non-English-speaking authors; and challenges in the future development of medical writing. Gain background knowledge by visiting the free medical writing education site www.ronbun.jp before attending this session. J. Patrick P. G. Barron, Professor Emeritus, Tokyo Medical University, and Adjunct Professor, Seoul National University Bundang Hospital
OS-36 • Market Access for Pharmaceuticals: Medical Writing Opportunities in Health Economics and Outcomes Research [Writing/Editing] Health economics and outcomes research (HEOR) is a diverse and growing area of medical writing. This session is designed for writers with an interest in HEOR-specific opportunities both within the United States and abroad. An introduction to basic HEOR concepts will be followed with a description of two specific HEOR document types: Academy of Managed Care Pharmacy (AMCP) dossiers and Health Technology Assessments (HTAs). These documents are used to evaluate new and existing pharmaceuticals for formulary placement, coverage,
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Full Program Schedule • saturday and reimbursement decisions. The AMCP discussion will summarize current dossier formatting guidance. HTA examples will focus on submissions requiring a systematic review and economic model. Caitlin Rothermel, MA, MPH, Principal, MedLitera, Vashon, WA Marcia Reinhart, Principal, Tantalus Medical Communications, Victoria, British Columbia
OS-37 • Medical Communicators as Content Managers [Writing/Editing] For many medical communicators their primary role is to write content. Yet content is created, managed, and translated using manual methods requiring enormous amounts of time and human intervention. We can no longer rely on people alone to have an in-depth knowledge of our content and rapidly respond to regulatory requirements. Content management and intelligent content can provide savings in time, money and the management of safety and regulatory changes. Medical communicators can take on the role of content manager and help the organization to be more effective in every aspect of content creation, management, and translation. Ann Rockley, MIS, FSTC, President, The Rockley Group Inc., Schomberg, Ontario
OS-38 • Translating Clinical Research to Policy: HTAs and their Context [Writing/Editing] What is a health technology assessment (HTA)? Is it different from a systematic review? How are HTAs produced and who uses them? What contributions do HTAs make in the translation of clinical research to health care policies? Where can I find an HTA of a health care intervention I’m interested in? Is there a role for medical writers in the production of HTAs? How does the field of HTA in the United States differ from that in Canada, Europe, and Australia? This session will provide answers to such questions and will tell some interesting “HTA stories,” such as the controversy surrounding risk-reducing mastectomy or oophorectomy in women with BRCA1 or BRCA2 genetic mutations. Teresa L. Rogstad, MPH, Research Project Leader and Senior Medical Research Leader, Hayes, Inc, Louisville, KY
OS-39 • Hands On: Using Styles in Microsoft Word to Make Your Work Shine [Technology] More than being a simple document creation tool, Microsoft Word provides users with styles to help them format their documents in consistent, cohesive ways. The styles in Word can allow users to easily create headings of all different levels, outlines, quotes, tables of content, and various levels of emphasis. However, styles are often underused in favor of manually manipulating text using the formatting tools. Participants will learn how to create their own styles, with a focus on headings, bullets, and tables of content; save them for future use; and work with them consistently to make their work stand out. Bring your laptop with Microsoft Word 2010. Margaret E. Caracappa, ELS, Editorial Director, Red Nucleus Solutions, Hamilton, NJ Sara Wuillermin, QA Editor, Red Nucleus Solutions, Hamilton, NJ
9:00–11:45 AM IS-03 • Intensive Seminar: Leading, Managing, and Writing in a Global Virtual Environment [Professional Relationships] (Ticketed event, with additional fee.) Leading, managing, and writing in a global virtual environment requires different levels of communication than in an office setting. Well-defined communication techniques and fostering of individual and group relationships are key to leading and managing successful virtual teams. Sample communication scenarios will be presented and audience participation is encouraged to assist in the identification of possible outcomes. An overview of online meeting platforms and virtual meeting etiquette will be provided. This interactive session will provide attendees with effective team-building exercises and solicit questions and experiences from attendees. One panel member will be video-conferenced into the presentation. Lima Chutkan, PhD, RAC, Medical Writer, Whitsell Innovations, Inc., Chapel Hill, NC Natalie Herr, PhD, Medical Writer, Whitsell Innovations, Inc., Chapel Hill, NC Mary Jane Lunsford, Director, Medical Writing, INC Research, Austin, TX Mary E. Siefert Zander, PhD, Manager, Medical Writing, INC Research, Cincinnati, OH
Michelle M. Ostrander, Associate Editor, Directory Services, Hayes, Inc., Loveland, OH
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AMWA’s 74th Annual Conference
Full Program Schedule • saturday 9:00 AM–12:00 PM WS-48 • Advanced Writing (ADV) #706 [Writing/Editing] 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 of experience in editing or writing. APPROXIMATE HOMEWORK TIME: 2-3 HOURS. Marianne Mallia, ELS, Manager and Senior Medical Writer, Texas Heart Institute, Houston, TX
WS-49 • Understanding and Reporting the Performance Characteristics of Diagnostic Tests (ADV) #725 [Relevant Skills] This workshop, designed for experienced medical writers and editors, teaches participants how to interpret and report the performance characteristics of diagnostic tests in the biomedical literature. Participants will practice applying a set of detailed guidelines for reporting various test characteristics. APPROXIMATE HOMEWORK TIME: 3 HOURS. Tom Lang, MA, Principal, Tom Lang Communications and Training International, Kirkland, WA
WS-50 • Understanding Sample Size and Study Power (ADV) #729 [Relevant Skills] This workshop is intended for writers and editors who are familiar with basic biostatistics and research methods and who want to improve their understanding of and ability to communicate about sample size and the influence of a study's “power”—the ability to detect a measured and statistically significant effect. The workshop leader will also examine the role that precision and confidence intervals play in interpreting and reporting a study’s power. These concepts will be addressed from the vantage points of planning studies and of interpreting and assessing completed studies. The workshop leader will emphasize effectively communicating the related concepts to lay and professional audiences. It is recommended that participants have previously taken Statistics for Medi-
cal Writers and Editors and Observational Research Design. Participants would also benefit from having taken Risks and Ratios. APPROXIMATE HOMEWORK TIME: 3 HOURS. Bart Harvey, MD, PhD, Associate Professor, Dalla Lana School of Public Health, University of Toronto, Ontario
WS-51 • Effectively Searching Online Databases (ES/ EW/FL) #2004 [Technology] This workshop is conducted via 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 Pharma Group, Southport, CT
WS-52 • Outlining for Writers and Editors (ES/EW/FL) #2007 [Writing/Editing] 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. Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Nashville, TN
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Full Program Schedule • saturday WS-53 • Punctuation for Clarity and Style (ES/G) #2008 [Writing/Editing] 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. Helen E. Hodgson, PhD, Westminster College, Salt Lake City, UT
WS-54 • Organizing the Medical Paper (CP/EW/FL) #3010 [Writing/Editing] 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 section, and the importance of tying each of the sections together. APPROXIMATE HOMEWORK TIME: 2-3 HOURS. Thomas Annesley, PhD, Professor, University of Michigan, Ann Arbor, MI
WS-55 • Usage: Choosing the Right Word for the Job (CP) #3027 [Writing/Editing] 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: 1 HOUR. Stephen N. Palmer, PhD, ELS, Senior Scientific Medical Writer, The Texas Heart Institute, Houston, TX
WS-56 • Using Design to Improve the Readability of Medical Documents (CP) #3028 [Relevant Skills] In this combined lecture/discussion format, participants without formal design training will learn basic principles of
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effective document design. The workshop will emphasize using design to make medical documents readable and accessible, not attractive per se. The presentation will focus on four Gestalt principles of visual perception—contrast, alignment, repetition, and proximity—with applications ranging from the whole document to individual characters. The discussion will include data displays such as charts and tables. APPROXIMATE HOMEWORK TIME: 2 HOURS. Lyn Gattis, Associate Professor, Department of English, Missouri State University, Springfield, MO
WS-57 • Introduction to the Nervous System (SM/SBS) #3517 [Health and Medicine] This workshop on the normal biology of the nervous system is intended for writers and editors without a formal science background, although some knowledge of cell biology would be helpful. The workshop leader will cover how the unique anatomy (structure) and physiology (function) of individual nerve cells allows them to form complex networks that process information. The gross anatomy of the nervous system and the functional circuits linking the nervous system to other organs will also be described. APPROXIMATE HOMEWORK TIME: 2–3 HOURS. Naomi L. Ruff, PhD, ELS, RuffDraft Communications LLC, Duluth, MN
WS-58 • Ethics in Communicating Science and Medicine (SM) #3524 [Ethics] This workshop is required for individuals working to earn the Concepts in Science and Medicine specialty certificate. It 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.
AMWA’s 74th Annual Conference
Full Program Schedule • saturday Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach, VA R. Michelle Sauer, PhD, ELS, Research Development/Assistant Professor College of Natural Sciences & Mathematics University of Houston, Houston, TX Tami Ball, Principal Medical Writer, inVentiv Health Clinical, Asheville, NC
WS-59 • Investigational New Drug Applications (RR/ PH) #4008 [Regulatory] 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. Jennifer Grodberg, PhD, RAC, Carlsbad, CA
Paula Fischthal, MA, Associate Director, Clinical Development, AstraZeneca Gretchen Griffin, MS, Manager, Medical Writing, Pharma Start, Rockville, MD
AMWA Community Lounge and Demos
Beverage Break
10:30 AM–12:00 PM OS-40 • How to Use the 3 Ps of Powerful Content: Plain, Personal, Possible [Writing/Editing] A pea placed under a mattress made the fabled princess wake up and take action, but you won't need to be so sneaky about it. You too can use Ps—the 3 Ps (plain, personal, possible)— to spur people to take action when it comes to their health. Join this how-to seminar to learn how you can use the 3 Ps to help patients and health consumers understand, engage, and believe. Evaluate and improve text and audiovisual content samples from across the discipline and master practical tips for bringing the 3 Ps into your own work. Katy Magee, MA, Senior Content Manager, Content Strategy and Shared Decision Making, Healthwise, Incorporated, Boise, ID Carrie Henley, Senior Content Manager, Behavior Change, Healthwise, Incorporated, Boise, ID
WS-60 • Writing a Protocol in Compliance with ICH Guidelines (RR) #4018 [Regulatory] Learn key elements needed for protocol writing. Workshop leaders will review regulatory requirements including International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP), provide an overview of who uses the protocol, and show participants how the use of templates can shorten protocol development time. Participants will learn how study objectives and endpoints differ and why these differences matter. Participants will learn how to gather information, manage the review process, and understand who will be using the protocol. Pitfalls in protocol development process will be discussed, including the common reasons for protocol amendments and how to avoid them. APPROXIMATE HOMEWORK TIME: 3 HOURS.
9:00 AM–12:00 PM
10:00–11:00 AM
OS-41 • Introduction to Pharmacokinetics and Pharmacodynamics and Reporting Pharmacokinetic Results [Regulatory] Have you turned down work or assignments for clinical studies for lack of expertise in pharmacokinetics (PK)? Do you skip the PK section of your clinical study reports, even when the PK objectives are fairly straightforward? Begin to close that gap with this session, which provides an overview of the basic concepts of drug pathways through the body and some rudimentary analyses. In the first part of the session, you will learn about the PK of a few commonly known drugs and how their PK properties relate to safety, efficacy, and pharmacodynamics. In the second part of the session, you will learn about a few common PK trial objectives and how to interpret and report the data analyzed in these trials. This session will help you understand basic PK analyses for clinical study reports so that you will be better equipped to write the next PK section or PK study. Susan Bairnsfather, CEO, EPharmaTech, Shreveport, LA Michelle L Eggen, MA, Senior Medical Writer, Boehringer-Ingelheim Pharmaceuticals, Inc., Omaha, NE
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Full Program Schedule • saturday OS-42 • Rules of Engagement: Writers and Editors [Professional Relationships] In this session, a team of writers and editors will share their experiences in working collaboratively to create publications. The interactive discussion will cover working as a team, setting the publication up for success, recognizing the value of an editor, optimizing efficiencies, and sharing best practices for working as a team. Using a case-based approach, we will discuss avoiding pitfalls and highlight best practices to make the writer/editor collaboration a success. Linda T. Wagner, PharmD, CMPP, Principal Medical Writer, Envision Pharma Group, Southport, CT Tabatha L. Cannata, Editorial Manager, Editorial Solutions, Envision Pharma Group, Southport, CT Elizabeth Wassmer, Editor, Editorial Solutions, Envision Pharma Group, Southport, CT
OS-43 • Surviving Your Desk Job: Tips for Bringing Movement and Relaxation into Your Day [Soft Topics] Medical writers face daily stresses in body and mind: deadlines, sitting too much, ergonomic strains, 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. In this session, we will present tips for incorporating movement and relaxation into a writer's daily life. Learn about the consequences of a sedentary job and strategies to increase activity while getting work done. In addition, a TriYoga-certified instructor will guide you through 10 yoga tips that you can do right now. This in-the-flow experience of yogic breathing, stretches in your chair, and mindful meditation will help you to increase energy physically, mentally, and spiritually. Mary Kemper, Medical Editor, Mayfield Clinic, Cincinnati, OH Ann M Winter-Vann, PhD, Senior Medical Writer and Consultant, Whitsell Innovations, Inc., Chapel Hill, NC
12:15–1:30 PM Roundtable Discussions with Lunch (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.
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S-01 • The AMWA Journal and Other Health Care Communication Publications Join this roundtable to discuss the AMWA Journal and other publications with a strong interest in the topic of medical communication. We will discuss differences in publication audiences, approaches, and goals, and the importance of research in medical communication. We will also discuss the types of articles currently presented in the AMWA Journal, and participants will have an opportunity to make suggestions for improving the journal. Victoria J. White, MA, ELS, Editor, AMWA Journal, Tampa, FL
S-02 • AuthorAID: a Service and a Chance to Serve This roundtable will focus on AuthorAID, an international project to help researchers in developing countries to write about and publish their work. Come learn how all of us as medical communicators can benefit from resources in AuthorAID. And see how medical communicators can be of international service through this project. Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX
S-03 • Confessions of a Continuing Education Addict The goal of this roundtable is to enable aspiring and experienced medical writers to exchange information about continuing education (CE) opportunities. The roundtable will be led by a self-identified CE addict, who will share her experiences with CE (eg, where she found CE opportunities, how she benefited from CE, and what kinds of CE might be beneficial to medical writers). Participants will be encouraged to share their own experiences, tips, and recommendations related to CE. NB. Don't forget your sense of humor. Carrie-Lynn Keiski, PhD, Research Communications Officer, University Health Network, Toronto, Ontario
S-04 • Demonstrating Leadership When You’re Not the Leader Medical writers often serve in supportive roles, driving decisions rather than making them. Yet, a writer’s credibility and professionalism can influence the quality of his or her interactions and how effectively projects are completed. In addition to strong writing skills, medical writers frequently rely on strong leadership skills to achieve project success. Self-awareness,
AMWA’s 74th Annual Conference
Full Program Schedule • saturday composure, social competence, and drive greatly impact your effectiveness. In this roundtable, we will discuss these attributes and suggest methods for improvement. This roundtable is relevant for attendees who have an interest in professional development, particularly those who work directly with authors or in team environments. Lori M. Smette, PhD, Medical Writing Senior Manager, Amgen, Inc., Thousand Oaks, CA
S-05 • Desperately Seeking Standards: Tracking Changes in PowerPoint Medical communicators have become accustomed to using the track changes feature in MS Word, and with PowerPoint as the industry standard for developing slide decks, medical communicators are left to approximate a “track changes look” on slides and in slide notes. Documenting edits and charting versions add a lot of time to an edit and every client wants something different. We will discuss the myriad ways to track changes in PowerPoint and identify best practices for look, feel, and expediency. Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Nashville, TN
S-06 • Fostering Successful Partnerships Between Editors and Authors at Academic Medical Centers We will explore ways to develop positive and effective working relationships with the authors whose work we edit. Participants will discuss topics such as 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. Markeda Wade, ELS, Scientific Editor, The University of Texas MD Anderson Cancer Center, Houston, TX
S-07 • A Fresh, Uncommon View of Health Policy Issues of the Day Learn more from a perspective you have probably never heard before about critical health care policy issues of the day: the risks and challenges facing health care reform, the business of Medicare, and the overuse of medical care. Rosemary Gibson, MSc, Senior Advisor to The Hastings Center, Garrison, NY
S-08 • From Academic Scientist to Freelance Writer: Sharing Lessons Learned What are your fears about moving into freelancing? Can you go straight from the academic world to running your own freelance business? What personality traits does it take? Where can you learn the skills you need? What mistakes should you avoid, and how can you work within a tight budget? Join us for a discussion of these questions and some answers from personal experience. It can be done! Kathy Boltz, PhD, Freelance Medical Writer, Phoenix, AZ
S-09 • Grantsmanship 101 While securing external funding for academic research is expected, few investigators receive grant writing training during their graduate studies. As funding rates continue to decrease, competition for federal funding continues to increase, thus a basic understanding of the tools (or granstmanship) successful grant writers use can give a competitive edge to any grant. We will discuss how the use of persuasive language, typographical changes, figures, tables and other visual components of a grant affect the mood of a reader and may affect the ability of the proposal writer to secure funding. Kristina M. Wasson-Blader, PhD, ELS, Scientific Editor, University at Buffalo
S-10 • Health Care Brand Journalism: Connect with Your Audience Through Storytelling on Websites, Blogs and Social Media You know “that person” who lights up a room and makes people laugh and agree with him or her? That's the power of a well-told story. Today, thanks to the Internet, anybody can publish. The challenge? Information overload. At this roundtable, learn digital journalism strategies for telling authentic, unbiased, and compelling stories that help brands be human and earn trust. Linda G. Hughes, MA, Healthcare Brand Journalist, LG Hughes, LLC, Indianapolis, IN
S-11 • How Do You Use PR/Communications to Promote Research, Programs, and Services? Participants in this roundtable discussion will have an interactive session to discuss strategies for developing and executing
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Full Program Schedule • saturday communication plans to promote medical discoveries. The leader will share tips, guidelines, and examples of real cases. Katrina R. Burton, BS, MD Anderson Cancer Center, Houston, TX
S-12 • How Important Are Soft Skills in the Technical World of Medical Communication? The topic of soft skills for writers in any technical or medical field is always worthy of discussion. At this roundtable, we will compare the importance of soft skills versus medical and technical knowledge for writers at different career stages, within a changing economy, and how they can be most effectivley developed and leveraged. Bring your ideas for soft skills you think are most important in the field of medical communication. Lori G. Rochelle, PhD, Senior Medical Writer, Inventiv Health Clinical, Durham, NC
S-13 • How to Stop Your Content from Managing You Is your content managing you? Too many different versions to decipher? Coordination nightmares for translated content? Lack of an audit trail for regulation requirements? You can turn it around and take control of your content again. Join our roundtable discussion for tips and ideas on how to take back control of your content. Suzanne Mescan, Director of Marketing, Vasont Systems, Emigsville, PA
S-14 • How to Write a Safety Narrative for a Clinical Study Report Safety reporting is a critical part of the clinical study report as well as other pharmacovigilance activities. Regulatory authorities and the International Conference on Harmonisation require narratives that describe each death, each other (nonfatal) serious adverse event, and other significant adverse events that are considered to be of special interest. A narrative must present all of the important aspects of the case as a brief but comprehensive medical story. We will discuss the whys and wherefores of clinical narratives, who writes them, and provide some sources for templates and narrative information. Barbara F. Liptak, MS, Principal Medical Writer, TKL Research, Inc., Rochelle Park, NJ
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S-15 • Illuminating the Impact of the Sunshine Act on Freelances Everyone is talking about the far-reaching, and as of yet largely undefined, effects the Sunshine Act may have on pharmaceutical companies, health care professionals, medical communications companies, and medical education companies. But what about freelance medical writers? In this roundtable, we will discuss the potential impact of the Sunshine Act on freelances and explore what we can do to protect ourselves from the fallout and position ourselves for the opportunities to come. Brian Bass, President, Bass Global, Inc., Robbinsville, NJ
S-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. Sandra R. Distelhorst, ELS, Senior Writer, Northwest Health Communications, Edmonds, WA
S-17 • It's Just Business: How and When to Fire a Client While no one likes being fired (or being the one who has to fire employees or contractors), it's a part of business. This roundtable will discuss some reasons why it's acceptable to fire your client, as well as how to do it without burning a bridge. Examples of what have and have not worked will be provided. Bring your questions and examples for the group to discuss. Michelle Dalton, ELS, Founder, Dalton & Associates, Reading, PA
S-18 • Keep Your Record Clean while Running a Great Social Media Campaign Did you know that a Facebook post could lead to civil or criminal penalties? Medical social media is one of the most difficult platforms to be successful on. Medical laws such as HIPAA, Stark, Sunshine, and Anti-Kickback affect social media, and it can be challenging to come up with great content while working under these laws. This roundtable discussion will feature tips on how to create engaging social media campaigns, and provide a forum for talking about the structure of a campaign. Rachel Meyer, Director of Creative Content & SEO Analyst, Medical Marketing Solutions, Mesa, AZ
AMWA’s 74th Annual Conference
Full Program Schedule • saturday S-19 • Managing Multiple Personalities in the Face of a Deadline Dealing with difficult personalities when collaborating on medical communication projects can be challenging. Some team members ignore internal deadlines while others pay little regard to the needs and contributions of other team members. Having the right management and communication skills can be invaluable when dealing with such personalities. In this roundtable discussion, we will discuss different styles of communication and techniques that may help deal with difficult personalities. Margaret Kinyanjui, Research Communications Officer, University Health Network, Toronto, ON
S-20 • Medical Writing Remotely Join this roundtable to discuss your experiences working remotely in a medical writing position. We will share ideas and tips for how to be successful in this type of career. Melanie E. Schmitt, MS, Medical Writer, Medpace Inc., Cincinnati, OH
S-21 • Networking for Continuing Education Writers Join this roundtable to discuss the common challenges and issues in writing continuing education for health care professionals. We will talk about best practices in all aspects of writing continuing education materials, including creating needs assessments, developing learning objectives, finding the best resources, selecting the most appropriate media, and building questions. Eve J. Wilson, PhD, CCMEP, Owner, MORPHOS Medical Education, Bowie, MD
you’re already retired, or just thinking about it, this promises to be a lively discussion. Donna Miceli, Retired Freelance Medical Writer, Fort Myers, FL
S-23 • Novel—and Low-Cost—Ways to Market Your Freelance Business Whether you are a novice or a pro, you can never stop marketing your freelance medical writing business. In this roundtable discussion, we’ll discuss how to use social-media marketing, permission marketing, and content marketing to get more clients. We’ll review what to write about, how to get people to opt-in, and tactics to drive traffic to your website or blog. Come prepared to share other unique strategies you use that give you the most marketing bang for your buck. Cyndy L. Kryder, MS, CCC-SP, Medical Communication Specialist, Phoenixville, PA
S-24 • Pros and Cons of Specializing within Medical Communication How can medical communicators be most effective: by specializing in a narrow range of therapeutic areas or document types, or by being able to take on a wide range of projects? Which approach is best for career development? An experienced freelance writer and editor who still struggles with this issue will lead a discussion of the pros and cons of each approach. Ideally, we will get perspectives from a wide range of participants, including experienced writers and those just starting out, generalists and those who specialize, freelances and employees, and those who hire others. Naomi L. Ruff, PhD, ELS, Principal, RuffDraft Communications LLC, Duluth, MN
S-22 • Networking for Retired (and Semiretired) Medical Communicators This roundtable gives retired—and semiretired—medical communicators an opportunity to share their thoughts on, and experiences with, retirement. How easily have you made that transition? Was it easier, or more difficult than you expected? What steps have you taken to fill in the hours you previously spent working? Are you feeling bored and missing the pace of working? Or have you become so busy with other activities that you wonder how you ever had time to work? Whether
S-25 • Sales Training Writers Unite! Do you write or are you interested in writing sales-training materials? If so, join this roundtable to discuss the unique deliverables and regulatory requirements associated with this type of writing. We’ll talk about the basic components that appear in nearly all sales-training modules, the differences in writing for print versus other media, and the challenges in finding reference sources that pass muster during medicalregulatory-legal review. Facilitator TBD
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Full Program Schedule • saturday S-26 • So, You're Going to Take the BELS Exam If you've been thinking about taking the BELS exam, but you're worried because you don't know what to expect or you haven't taken a test in 20 (or more!) years, join us for this discussion. We'll address how to determine if you're currently a good candidate for the exam. We'll also talk about the format of the exam, different ways to prepare for it, and tips to make the whole experience less intimidating. Leslie E. Neistadt, ELS, Managing Editor, Saint Louis University, St Louis, MO
S-27 • So You've Hired a New Medical Writer—How to Do a Good Job of Onboarding Effectively onboarding a new or transitioning medical writer enables the writer to acquire the necessary knowledge, skills, and performance level to quickly become a productive, efficient, and credible member of your organization. We will discuss topics such as the benefits and challenges of a structured onboarding process, as well as the elements that facilitate the onboarding process. Caryl L. Burke, MS, PMP, Medical Writer, Medpace, Cincinnati, OH
S-28 • Take It to the Next Level: Career Planning For Freelances As a freelance, have you ever wondered, where is my career going? What's next? A freelance medical writer's career unfolds in distinct stages, with unique professional opportunities at each stage, from landing your first client to becoming a thought leader. Your marketing and pricing strategies should be tailored accordingly. This roundtable is designed for freelances at every career level who want to learn and share strategies about how to maximize current opportunities and “take it to the next level” professionally. Ann M. Volk, MA, Freelance Medical Writer, Volk Medical Communications, Dover, DE
S-29 • Telecommuter Etiquette This roundtable will be an interactive discussion on best practices for telecommuting. It will include tips and hints from the leader (who has over a decade of telecommuter experience) and invites sharing of working practices from all participants. Our discussion will focus on three themes: how to manage
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workflow, how to set expectations for response times, and how to build rapport from a distance. We will also talk about perceptions of telecommuting and times when a telecommuter changing the nature of his/her communication (having faceto-face meetings, switching from e-mail to the phone, etc) is important. If time permits, we will share ideas on staying connected while being a telecommuter. Robin Whitsell, BPh, President, Whitsell Innovations, Inc., Chapel Hill, NC
S-30 • The 10 Most Important Strategies for Freelance Success Join this roundtable to learn about 10 critical topics from the perspective of a medical writer/editor with 20 years of experience as an independent contractor. Our discussion will address such issues as maintaining your business image, enhancing your skills, investing in the business, setting rates, networking, managing projects, advocating for yourself, analyzing your business practices, understanding legal and tax issues, and coping with difficult clients, among others. This discussion is appropriate for both new freelances who are unsure of what is involved and long-term freelances who may want a different perspective. Laura J. Ninger, ELS, President, Ninger Medical Communications, LLC, Rutherford, NJ
S-31 • Tool Talk: Apps and Tools for Social Media It's not enough just to use a social media platform, you need to make it useful and efficient to meet your needs. Tools are available to use various platforms effectively depending on the device. Tools are also out there to help you measure your effectiveness in using the media platform. Let's talk about our experiences. What we like and why, what works well and what didn't. Join us to find and share ideas about various platforms (Twitter, Tumblr, LinkedIn, Facebook, etc) and ways to make social media use more productive and efficient. Larry Lynam, MA, Principal / Writer and Facilitator, The Lynam Group, Coral Springs, FL
S-32 • Turning a Tough Situation into a Success: Integrating Global Partners Participants will discuss the experiences, challenges, and best
AMWA’s 74th Annual Conference
Full Program Schedule • saturday practices in working with medical writers and editors outside the United States. David M. Clingan, Senior Medical Editor, inVentiv Health Clinical, San Antonio, TX
S-33 • What’s Your Problem? Problem-Solving Discussion on Freelancing Bring your most challenging problems in freelancing and get help in solving them from a veteran freelance and other colleagues. Caitlin Rothermel, MA, MPH, MedLitera, Vashon, WA
S-34 • When it’s Time to Blow the Whistle: Writers’ Power in Challenging Ethically Compromising Situations Attend this roundtable discussion to listen and share your own stories of rising to the challenge (and lessons learned in the process) of being faced with ethical compromises, or how you might do so if ever needed. Be ethically rejuvenated and empowered! Scott Harrington, PharmD, RPh, Tucson, AZ
S-35 • Writing for a Global Audience—What Can Medical Writers Learn from the Aerospace Industry? Can medical writers borrow from the aerospace industry to improve their writing for a global audience? Join this roundtable to learn about the basics of simplified technical English (STE), developed by the aerospace industry. Some highlights of STE are assigning one word for one function, procedure, or object; not using more than three nouns together; using active voice; and using an approved lexicon of approximately 900 words. We will discuss which elements of STE may be best applied to medical communication. Karen M. Matthews, Medical Writer, Inventiv Health Clinical, Sanford, NC
S-36 • Writing the Meaningful Informed Consent for the Research Participant A well-written Informed Consent Document is crucial to facilitate autonomous decisions for research subjects. This roundtable discussion will focus on how templates, lay-term data-
bases, and IRB-approved language can aid the writing process. The Leader and participants will share tips and advice on: (1) incorporating the elements of Plain Language to improve patients’ understanding, (2) how to describe side effects in lay terms, (3) use unambiguous language to facilitate autonomous decision making, and (4) how to make a user-friendly document with use of text, graphics, and white space. Michelle Eby, PharmD, CCRP, Consumer Safety Officer, Food and Drug Administration, Silver Spring, MD
S-37 • Writing for the Medical Device Industry Participants will discuss segueing into writing about medical devices. The discussion will focus on the key differences between writing for medical devices versus drugs and biologics, opportunities for medical writers in the device industry, jurisdictional distinctions between the governing regulatory bodies, and strategies for obtaining job leads. Scott C. Thompson, ELS, Principal Medical Writer, Medtronic, Memphis, TN
S-38 • You Are Not Alone! Creative Strategies in Sharing Work for Mutual Benefit Find yourself spending too much time on drudgery and no time or energy left for doing your best work? Using up all your time and energy on tasks that are boring, repetitive, and meaningless? Not the best use of your time? Don’t get mad, get support! Participants will brainstorm how to get help, possible resources, and the pros and cons. Myrna Faulds, Principal for BioExpressions, Millbrae, CA
1:45–3:15 PM OS-44 • How To: Best Practices for Performing QC [Regulatory] Quality control (QC) is an essential process in medical writing. Due to the resources invested in each project and the potential consequences of errors, medical writers in all fields must ensure that their information is accurate. Writers may be asked to QC documents; however, the QC process can be overwhelming, and new writers may not know what is expected or how to proceed. This interactive session will provide an overview of the QC process and its importance and demonstrate best prac-
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Full Program Schedule • saturday tices for performing QC and sending a document for QC. These best practices will be reinforced with individual exercises. Lima Chutkan, PhD, RAC, Medical Writer, Whitsell Innovations, Inc., Chapel Hill, NC
OS-45 • How to Design, Develop, and Execute a Successful Webinar [Technology/Social Media] As medical communicators, we can harness the value of webinars to increase our online presence and marketing efforts. Webinars can be used to share information and interact with our colleagues. Discover the power of webinars to present and deliver information to your audience. You will learn about multiple online tools that can be used to setup a webinar. This session will address the main components of webinar design and execution, including advertising, processing registration, follow-up e-mails, and recording the webinar. We will also explore the multiple tools available to setup a webinar, including, but not limited to GoTo Webinar, WebEx, and Google Hangouts. Ruwaida Vakil, MS, Owner, ProMed Write LLC, Somerset, NJ
OS-46 • How To: a Practical Introduction to the Language and Rhetoric of Medical Device Software [Regulatory] Explore practical tools for using language to describe contemporary medical device and health care software in this interactive session. Participants will apply concepts in collaborative exercises, building a forum for discussion of the advantages and pitfalls of descriptive language and strategic rhetorical selections for informing and influencing publication, institutional review, regulatory, and grant decision-making. This session is designed to provide a practical toolset for medical writers to interact with diverse and rapidly changing medical software, empowering medical writers at all levels to effectively bridge the gap between medical practitioners, software experts, and diverse document stakeholders. Angela N. Johnson, BFA, MSE, PMP, Senior PB Clinical Writer, GE Healthcare, Waukesha, WI
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OS-47 • Introverts versus Extroverts: Does it Really Matter in the Medical Writing World? [Soft Topics] Are you an introvert in an extrovert world? Does it ever seem like everyone around you is outgoing and comfortable speaking in groups, but you aren't? Or, as an extrovert, do you feel like you need to talk more to compensate for the introverts in the group? This debate, led by an introvert and an extrovert, will help you determine which personality type applies to you and whether it makes a difference in the medical writing world. David M. Clingan, Senior Medical Editor, inVentiv Health Clinical, San Antonio, TX Jodi M. Pollock, Principal Medical Writer, inVentiv Health Clinical, Apex, NC
OS-48 • When the Deadlines Won’t Wait: Tools for Onboarding a New Medical Writer [Professional Development] You’ve been there–you need to hire a new writer and the deadlines are already looming. You must work to quickly orient, train, and integrate your new writer, and it doesn't help that your time is also short. You know that onboarding done well results in increased productivity, confidence, and greater work quality. But in this environment, how can you efficiently equip the new writer to quickly become a productive member of the team? This session will equip you with some basic, efficient, and no-frills tools to quickly integrate a new medical writer into your medical writing team. The same strategy can be applied to onboarding in general. Robin Robinett, MS, PhD, Director, Merck & Co, Inc., West Point, PA Caryl L. Burke, MS, PMP, Medical Writer, Medpace, Cincinnati, OH
2:00–2:45 PM Annual Business Meeting All AMWA members are encouraged to attend to get an update on AMWA from 2013-2014 President Brian Bass and Treasurer Christine Wogan, MS, ELS, to witness the passing of the gavel to Karen Potvin Klein, MA, ELS, the 2014-2015 President, and to meet the 2014-2015 officers and Executive Committee.
AMWA’s 74th Annual Conference
Full Program Schedule • saturday/sunday SUNDAY, October 12
3:00–3:30 PM Beverage Break
9:30 AM–1:30 PM
3:30–5:00 PM Closing Session, featuring Alvarez Award Address This session features Rosemary Gibson, MSc, who will deliver her award address “.” In addition, the Eric W. Martin Award (Professional Audience) will be presented to Art Gertel (with Cindy Hamilton, Adam Jacobs, Gene Snyder, and Karen L. Woolley) for “The Global Alliance of Publication Professionals: Update on a Small Group with a Big Mission,” and the Eric W. Martin Award (Public or Health Care Consumer Audience) will be presented to Randi Redmond Oster for “A Beautiful Choice: Living, and Dying, with Dignity.”
GRACELAND TOUR Put on Your Blue Suede Shoes and tour this historic site. Even if you’re too young to have been an Elvis fan, Graceland offers a glimpse into a significant time in music history and a peek into the life of an extraordinary man. Transportation will pick you up at 9:30 AM at the AMWA hotel (the Sheraton) and will return between 1:00 and 1:30 PM. The ticket price is $40.
5:00–6:00 PM Closing Reception and 75th Anniversary Kickoff Celebration (cash bar) Get All Shook Up and join us as we begin a full year of recognizing AMWA’s 75th anniversary, a celebration that will culuminate in the 2015 Annual Conference in San Antonio.
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AMWA’S CERTIFICATE Program Gain recognition for your commitment to excellence in medical communication by earning an AMWA certificate. The AMWA certificate program allows medical communicators to increase their knowledge, refresh their skills, and investigate new areas of practice.
Regulatory & Research: Develop specialized writing and science skills for regulatory and drug-development environments. Earn credit towards the Regulatory & Research Certificate through AMWA’s in-person workshops.
Eight AMWA workshop credits are necessary in order to earn an AMWA certificate. Credits may be earned through participation in in-person workshops or through completion of an AMWA Self-Study Module (Essential Skills only).
• Enrollment is required in order to begin earning credit towards an AMWA certificate. Only certificate enrollees can receive credits. • You may enroll in a certificate program after taking an AMWA workshop and still receive credit for the workshop, providing you enroll within 90 days of the workshop date and the workshop leader has indicated that you qualify for credit. • You may enroll concurrently in more than 1 certificate program. The Essential Skills certificate must be earned before the other certificates may be awarded. • The enrollment fee is a one-time fee of $150 (members) or $275 (non-members) for a six year term. Additional fees apply for workshop participation and self-study module purchases. • You must be logged into your member profile on the AMWA website in order to receive member pricing.
Enrollment in an AMWA certificate program is required in order to begin earning credit towards a certificate.
Pursue an AMWA Certificate Essential Skills: Improve basic editing, writing, communication, and bibliographic skills tailored for medical communicators. These truly are the essential skills for medical communicators and serve as the foundation for success in the profession. Earn credit towards the Essential Skills Certificate through AMWA’s in-person workshops or through completion of AMWA Self-Study Modules. One of these workshops must be Essential Ethics for Medical Communicators. One session of this workshop will be offered in Memphis, and an Essential Ethics self-study module will be available for purchase at a discounted price. Composition & Publication: Explore your inner editor with this certificate. Learn specialized editorial and publication skills, as well as in-depth consideration of issues in writing, editing, bibliographic research, education, and other topics of interest. Earn credit towards the Composition & Publication Certificate through AMWA’s in-person workshops. Concepts in Science & Medicine: Deepen your understanding of basic concepts in science and medicine. For those who are educated in non-science fields, the workshops in this certificate provide an orientation to a scientific area and a foundation for further study. The workshops in this certificate can provide those educated in science with opportunities to increase their knowledge and to learn about areas outside their specialties. Earn credit towards the Concepts in Science & Medicine Certificate through AMWA’s in-person workshops.
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Certificate Enrollment
Each certificate requires the successful completion of 8 credits. Each live workshop provides 1 credit. There are 7 self-study modules, 1 of which provides 2 credits while the other 6 provide 1 credit each.
Workshops for Certificate Credit • Credit workshops provide an interactive 3-hour learning experience with peers and AMWA’s expert workshop leaders. • 1 workshop credit must be ethics, and for specialty certificates (Composition and Publication, Concepts in Science and Medicine, and Regulatory and Research) up to 2 credits can be electives of your choice from other certificate areas. • Both members and nonmembers may take workshops, whether or not they are enrolled in a certificate program. However, in order to earn credit towards an AMWA certificate, you must be enrolled. • Workshops or self study modules may be completed in any order; however, to have the most successful learning experience, it is strongly recommended that you complete
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Basic Grammar I and Basic Grammar II workshops or the Basic Grammar & Usage self-study module before any of the other Essential Skills workshops or self-study modules. Each credit workshop includes a pre-workshop assignment (homework). If you are taking the workshop for credit, you must satisfactorily complete the assignment and return it to the workshop leader by the specified deadline. Even if you are not taking the workshop for credit, you are encouraged to complete the assignment. Typically, assignments will give participants background information for the workshop, be used during the workshop as a basis for discussion, or will help leaders assess the skill levels of participants. To receive credit for a live workshop, a participant must attend the entire workshop in addition to completing and submitting the pre-course assignment (homework) to the workshop leader by the specified due date. Participants in advanced workshops must complete the pre-course assignment and submit it to the leader by the specified deadline whether or not they are taking the workshop for credit. If a participant's completed assignment for an advanced workshop is not received by the deadline indicated, the seat in the workshop will be forfeited, and the participant will not receive a refund or workshop credit. Individuals attending the annual conference should plan to register early for workshops. Space is assigned on a first-come, first-served basis, and workshops fill quickly. Most workshops are limited to 30 participants; advanced workshops are limited to 16 participants. Once a workshop is full, it is closed.
Curriculum History AMWA headquarters staff records credit workshops successfully completed for participants enrolled in the corresponding program and awards the appropriate certificate when the requirements have been fulfilled. You may review your workshop curriculum history by logging in to AMWA.org and clicking on “My Curriculum History” in the quick links under Account Management.
Specialty Certificates To earn a 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 8 workshops within a specialty certificate program. One of these workshops must be the ethics workshop applicable to that specialty, and up to two can be electives of your choice from other specialty areas. Ethics workshops being offered at the 2014 Annual Conference: Essential Ethics for Medical Communicators (ES); Ethical Standards in Medical Publication (CP); Ethics in Communicating Science and Medicine (SM); Ethics of Communicating Regulated Drug Development Activities (RR) and Fundamentals of Ethics and Practical Applications (RR). You may take workshops in the specialty certificate program at any time, but you must earn an Essential Skills, Core, or Advanced certificate before you can earn the specialty certificate.
Rules for Earning Workshop Credit for Certificates • 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 12.) • Enrollment in the certificate program corresponding to the workshop designation (CP, ES, RR, or SM) is required. • For specialty certificates, up to two of the eight workshops can be electives of your choice from other specialty certificate areas. • Workshop homework must be received by the leader by the stated deadline. • The workshop must be attended in its entirety (3 hours). • There is a 10-minute grace period, after the stated starting time, for entering a workshop; after that, no one will be admitted and no refund or workshop credit will be given.
Pre-course Work (Homework) Each 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.
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Once you register for the conference, 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.
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. In order for a registrant to attend an Advanced workshop, the homework must have been completed and received by the workshop leader no later than the specified deadline, even if credit toward an Advanced certificate is not desired. If the homework is not received by the deadline, the registrant will not be allowed to attend the workshop, and no workshop credit or refund will be given.
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 September 17 unless an earlier deadline is indicated by the workshop leader on the homework.
For details on registering for workshops at the AMWA Annual Conference, please see page 8.
ANNUAL CONFERENCE COMMITTEE
Jennifer Maybin, MA, ELS Maybin Healthcare Communications, LLC, Branchburg, NJ
ADMINISTRATOR: Lori L. Alexander, MTPW, ELS Editorial Rx, Inc., Orange Park, FL
Donna Miceli DLM Writing Services, Ft. Myers, FL
ADMINISTRATOR ELECT: Noelle Demas, MS Panorama MedWriters Group, Inc, San Diego, CA
Kelly Schrank, MA, ELS Med Communications Inc, Canastota, NY
Keightley Amen, ELS ONS: Edge, Pittsburgh, PA
Scott Thompson, ELS Medtronic, Spinal Business, Memphis, TN
Adi Ferrara, MS, ELS HIV Vaccine Trials Network, Seattle, WA
Christine Welniak Upside Communications, Brooklyn, NY
David Galloway, ELS St. Jude Children’s Research Hospital, Cordova, TN
Wendy Wippel Medtronic, Inc., Memphis, TN
Larry Lynam The Lynam Group, Coral Springs, FL
WORKSHOP COORDINATOR: Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Nashville, TN
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execuTive committee / AMWA STAFF 2013–2014 EXECUTIVE COMMITTEE PRESIDENT Brian Bass President, Bass Global, Inc. Robbinsville, NJ
MEMBER RESOURCES ADMINISTRATOR Cyndy Kryder, MS Phoenixville, PA ONLINE COMMUNITY ADMINISTRATOR Kristina Wasson-Blader, PhD, ELS Scientific Editor, University at Buffalo Buffalo, NY
PRESIDENT-ELECT Karen Potvin Klein, MA, ELS Wake Forest University Health Sciences Winston-Salem, NC
PUBLICATIONS ADMINISTRATOR Deborah A Whippen Editorial Rx, Inc. Orange Park, FL
IMMEDIATE PAST PRESIDENT Douglas Haneline, PhD Professor of English, Ferris State University Big Rapids, MI
EXECUTIVE DIRECTOR (EX OFFICIO) Susan Krug, CAE
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 2014 ANNUAL CONFERENCE ADMINISTRATOR Lori L. Alexander, MTPW, ELS President, Editorial Rx, Inc. Orange Park, FL
AMWA STAFF EXECUTIVE DIRECTOR Susan Krug, CAE DEPUTY DIRECTOR Shari Rager, CAE EDUCATION AND CERTIFICATE PROGRAM MANAGER Lauren Ero, MS, MEd CONFERENCE PROGRAM MANAGER Becky Phillips
AWARDS ADMINISTRATOR Hilary Graham, MA INC Research Austin, TX
EDUCATION ASSOCIATE Andrew Buskey
CHAPTER RELATIONS ADMINISTRATOR Nick Sidorovich, MSEd Rolling Hill Media, LLC Chatham, NJ
MEMBERSHIP MANAGER AND DATABASE COORDINATOR Ann Silveira
EDUCATION AND CONFERENCE PROGRAM ASSISTANT Nyounti Tuan
EDUCATION ADMINISTRATOR Scott Kober, MBA, CCMEP Institute for Continuing Healthcare Education Philadelphia, PA
MEMBERSHIP SERVICES ASSOCIATE AND PUBLICATIONS MANAGER Rachel Spassiani, MA MEMBERSHIP PROGRAM ASSISTANT Samantha Nelson
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SPONSORS and EXHIBITORS Silver Sponsors
Bronze Sponsor
OTHER Sponsors
EXHIBITORS
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 June 2014.
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