AMWA 2015 Conference Registration Brochure

registration brochure www.amwa.org

The Ultimate Educational Event for Medical Communicators

TH TH AMWA’S ANNUAL CONFERENCE SEPTEMBER 30–OCTOBER 3, 2015

SAN ANTONIO, TX

Register Early and Save

WELCOME 2015 marks AMWA’s 75th year of supporting medical communication professionals through community and education. This year, AMWA’s Annual Conference is packed with exciting session formats, a plethora of expert speakers, presentations on timely topics, and a host of networking events.

AMWA’s budget-friendly annual conference offers many outstanding speakers at open sessions and workshops that give you a sound return on your investment. The basic registration fee includes access to two general sessions with award-winning speakers (opening and closing sessions), open sessions on a wide variety of topics, roundtable discussions, the Exhibit Hall, and several networking events.

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!

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CONFERENCE highlights

CONTENTS

Design Your Program

General Session Speakers. . . . . . . . . . . . . 4 Schedule at a Glance . . . . . . . . . . . . . . . . 5 Registration Information. . . . . . . . . . . . . . 7 Travel Information. . . . . . . . . . . . . . . . . . 10 Hotel and Location Information . . . . . . . 11 Full Program Schedule-Key . . . . . . . . . . . 12 Wednesday . . . . . . . . . . . . . . . . . . . . . 13 Thursday . . . . . . . . . . . . . . . . . . . . . . . 13 Friday. . . . . . . . . . . . . . . . . . . . . . . . . 26 Saturday . . . . . . . . . . . . . . . . . . . . . . 37 AMWA's Certificate Program. . . . . . . . . . 48 Annual Conference Committee . . . . . . . .50 2014-2015 Executive Committee. . . . . . . 5 1 AMWA Staff. . . . . . . . . . . . . . . . . . . . . . . 5 1 Sponsors and Exhibitors. . . . . . . . . . . . . 52

This year, it’s easier than ever to find the program events of most interest to you and your professional goals. We have expanded the use of topic area tracks to include all sessions and have developed Track Facts—simple reference guides that include sessions within each track. Track Facts, coupled with the Program at a Glance, will help you create your unique program quickly and easily.

Track Facts focus on 12 areas: • Editing • Ethics • Freelance • Health and Medicine • PR/Marketing • Professional Development • Professional Relationships • Regulatory • Relevant Skills • Social Media and Technology • Writing for Lay Audiences • Writing for Professional Audiences

AMWA’s Diamonds and Denim 75th Anniversary Reception and Dinner Whether you want to dress up, or play it casual, this special occasion will recognize what we’ve accomplished in the first 75 years of growing the medical communication profession, as well as share excitement for the next 75 years to come. The reception and dinner are included in your registration fee.

QUICK LINKS

Sablack Awards Luncheon

TRACK FACTS

The Sablack Awards Luncheon is another great networking event for all attendees, adding to the value of your conference registration fee. The Swanberg Award lecture, by the recipient of AMWA’s highest member award, will be presented at this important event as a free luncheon on Friday. In addition to the Swanberg Award, AMWA Fellowships will be presented at the luncheon. Come join in celebrating your fellow members’ achievements!

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PROGRAM AT A GLANCE

REGISTER ONLINE NOW

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general session speakers Hear from the best. During this year’s general sessions, two speakers will share their unique viewpoints on how medical communication has influenced, and continues to influence, the way patients and professionals consume scientific information.

Take Them on a Journey

Retractions, Post-Publication Peer Review, and Fraud: Scientific Publishing’s Wild West

Speaker: Jay Ingram

Radio Science Program Host, Book Author, and AMWA Alvarez Award Winner

Speaker: Ivan Oransky, MD

Jay Ingram is one of Canada’s best-known and most popular science personalities. Ingram has hosted both the premier radio science program in Canada, CBC’s Quirks and Quarks, and its TV counterpart, Discovery Channel Canada’s Daily Planet. In 2010, Ingram was appointed as a member to the Order of Canada for a lifetime of service in science communication. He has received several awards for his work, including the Queen Elizabeth II Diamond Jubilee Medal and honorary degrees from Carleton University, McGill University, McMaster University, King’s College, and the University of Alberta. A prolific author, Ingram has written 12 books, most of which have been best-sellers. His 13th, The End of Memory: A Natural History of Alzheimer’s Disease was published last month. His books have been translated into 14 languages. Since 2005, he has been Chair of the Science Communications Program at the Banff Centre. He is also co-founder and Chair of the arts and engineering mashup called Beakerhead, which began in September 2013 in Calgary.

AMWA’s 75th Annual Conference

Vice President and Global Editorial Director, MedPage; Book Author; and AMWA McGovern Medal Winner Ivan Oransky, MD, is the vice president and global editorial director of MedPage Today, co-founder of the MacArthur Foundation-funded Retraction Watch, and founder of Embargo Watch. He previously was executive editor of Reuters Health and held editorial positions at Scientific American and The Scientist. His publications have won numerous awards, including two Gold Eddie Awards for science magazines from FOLIO and the Magazine of the Year Award from the American Society of Business Publication Editors. He has authored or coauthored four books and written for numerous publications, including The Boston Globe, the New Republic, The Wall Street Journal Online, The Lancet, and The New York Times. Dr. Oransky earned his BA at Harvard and his MD at the New York University School of Medicine. While a student, he served as executive editor of The Harvard Crimson and as co-editor-in-chief of the medical student section of the Journal of American Medical Association. In addition to his work as a medical writer and editor, Dr. Oransky teaches medical journalism at New York University’s Science, Health, and Environmental Reporting Program, and he is a clinical assistant professor of medicine at New York University School of Medicine. Dr. Oransky currently serves on the board of directors and as vice president of the Association of Health Care Journalists.

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schedule at a glance Preliminary schedule as of June 2015

Wednesday September 30 8:30–11:30 AM Medical Writing Certification Examination (additional application process and fees) 9:00 AM–12:00 PM BELS Exam (additional application process and fees) 1:30–4:00 PM

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

5:00–6:30 PM

New to AMWA and Conference Orientation Program

6:30–8:00 PM

Welcome Reception in the Exhibit Hall and Posters on Display

Thursday October 1 7:00 AM–5:30 PM

Conference Registration and AMWA Information Desk Open

7:30–8:45 AM

Roundtable Discussions With Breakfast (additional fee)

9:00–10:30 AM

General Session With Alvarez Award Address

10:30–11:00 AM

Beverage Break in the Exhibit Hall

10:30 AM–4:00 PM

Exhibit Hall Open, Posters on Display

11:00 AM–12:00 PM

Open Sessions

12:15–1:45 PM

Lunch in the Exhibit Hall

Visit With the Poster Presenters

Workshops and Open Sessions

2:00–5:00 PM

3:30–4:00 PM

Beverage Break in the Exhibit Hall

6:00 PM

Meet in Hotel Lobby to Depart for AMWA Chapter Dinners

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schedule at a glance Preliminary schedule as of June 2015

Friday October 2 7:30 AM–4:00 PM

Conference Registration and AMWA Information Desk Open

7:45 AM–4:00 PM

Exhibit Hall Open, Posters on Display

7:45–8:45 AM

Breakfast With the Exhibitors

9:00 AM–12:00 PM

Workshops and Open Sessions

10:30–11:00 AM

Beverage Break in the Exhibit Hall

12:15–1:45 PM

AMWA Sablack Awards Lunch

2:00–5:00 PM

Workshops and Open Sessions

3:30–4:00 PM

Beverage Break in the Exhibit Hall

6:00 PM

Meet in Hotel Lobby for San Antonio Dine-Arounds

Saturday October 3

7:30 AM–3:00 PM

Conference Registration and AMWA Information Desk Open

7:45 AM–12:00 PM

Exhibit Hall Open, Posters on Display

7:45–8:45 AM

Continental Breakfast with the Exhibitors and Passport Prize Awards

9:00–10:30 AM

General Session With McGovern Award Address

10:30–11:00 AM

Beverage Break in the Exhibit Hall

11:00 AM–12:00 PM

Open Sessions

11:00–11:30 AM

Annual Business Meeting (Open to all AMWA Members)

12:00–4:00 PM

Exhibit Hall and Poster Take-down

12:15–1:45 PM

Roundtable Discussions With Lunch

2:00–5:00 PM

Workshops and Open Sessions

3:30–4:00 PM

Beverage Break

6:00–8:00 PM Diamonds and Denim 75th Anniversary Reception and Dinner (included with registration)

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registration information Key Dates • • • • •

Early registration rates apply through July 31.

Regular registration rates apply August 1 through September 15.

September 15 is the last day to register before onsite fees apply.

Onsite registration rates apply September 16 through October 3.

Last day to cancel conference registration and receive a partial refund is September 9 ($75 cancellation fee).

2015 AMWA Annual Conference Fees Full Conference Registration

EARLY

REGULAR

ONSITE

AMWA Member

$500

$600

$675

Nonmember

$675

$750

$775

AMWA Student Member

$300

$300

$350

Student Nonmember

$350

$350

$350

ONE DAY Registration

EARLY

REGULAR

ONSITE

AMWA Member

$200

$225

$275

Nonmember

$250

$275

$325

AMWA Student Member

$100

$100

$100

Student Nonmember

$200

$200

$200

EARLY

REGULAR

ONSITE

AMWA Member

$125

$125

$175

Nonmember

$150

$150

$175

EARLY

REGULAR

ONSITE

AMWA Member

$150

$150

$175

Nonmember

$175

$175

n/a

AMWA WORKSHOP Fees CREDIT WORKShop

advanced CREDIT WORKShop

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registration information Value and Return on Investment

AMWA’s budget-friendly annual conference offers many outstanding speakers at open sessions and workshops that provide a sound return on your investment. The basic registration fee includes access to 2 general sessions with award-winning speakers, open sessions on a wide variety of topics, the Exhibit Hall, and many networking events, including • Wednesday evening Welcome Reception • Beverage Breaks on Thursday, Friday, and Saturday • Thursday Lunch in the Exhibit Hall • Friday Networking Breakfast With the Exhibitors • Friday AMWA Sablack Awards Luncheon • Saturday Breakfast With the Exhibitors • Saturday AMWA 75th Anniversary Celebration Reception and Dinner

special events

EARLY/REGULAR

ONSITE

Breakfast Roundtable Topic Discussions, Thursday, October 1

$30

$35

Lunch Roundtable Topic Discussions, Saturday, October 3

$35

$40

Guest Pass to Wednesday Evening Welcome Reception

$25

$35

Guest Pass to Saturday Evening 75th Anniversary Reception and Dinner

$50

$60

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registration information General Registration Information

Policy on Children

Conference registration is an online process. Payments accepted include VISA, MasterCard, American Express, and check. Registrations will not be processed until payment is received.

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.

Registration for Special Events

Reservations are advised for special events; please reserve your space during the registration process. For events with limited space (eg, Roundtable Discussions), reservations are made on a first-come, first-served basis.

Please note that you are advised to register for complimentary events so that AMWA may plan accordingly.

Cancellation/Refunds

If you must cancel your conference registration, email your cancellation and refund request to annual_conference@amwa.org no later than September 9, 2015.

Refunds will be issued through your method of payment, less a nontransferable $75 registration cancellation fee.

Workshop cancellations are subject to a cancellation fee of $35 per workshop. Roundtables are subject to a cancellation fee of $10 per roundtable. Conference fees are nonrefundable after September 9, 2015. No refunds or credits will be given for failure to attend, late arrival, unattended events, or early departure.

Credit workshops have precourse work to be completed and submitted to the workshop leader no later than September 9, 2015, to be eligible to earn certificate credit. Some workshop leaders require hard copies of the precourse work to be mailed to them. In those cases, the precourse work must be received by (not postmarked by) September 9, 2015. Completion of precourse work is required for Advanced workshops, whether or not credit is sought.

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. There may be instances, however, where AMWA may need to cancel a workshop less than 14 days before the event.

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.

Guest tickets may be purchased for the evening receptions. You may purchase guest tickets online through the registration form or onsite at the conference.

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Substitutions

AMWA does not allow substitutes for conference registrations. Registration fees cannot be transferred to another person or from one event to another.

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registration/TRAVEL information Registration Questions

Registration and AMWA Information Desk Area Onsite

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.

If you have registered in advance, you can pick up your registration packet in the registration area beginning at 2:00 PM on Wednesday, September 30 in the Grand Hyatt Texas Ballroom Foyer. The packet will contain your identification badge and onsite program. You may also register onsite at the same location.

Participants With Special Needs

If you have a special need that may affect your participation in the 2015 Annual Conference, please contact annual_conference@amwa.org before September 9, 2015, to indicate your requirements and/or request accommodations.

AMWA staff will be available throughout the conference to answer your questions about membership services and benefits.

Consent to Use of Photographic Images and/or Audio Reproduction

New Members and First Timers

If you’re a new AMWA member or have never attended an AMWA annual conference, don’t worry—lots of AMWA members and staff are on hand to help welcome and guide you. Join us on Wednesday, from 5:00–6:30 PM for the Steps to Success: Annual Conference, AMWA, and Beyond session. The event will feature AMWA staff, chapter leaders, and conference mentors who will help first-time attendees get the most out of the conference.

Registration and attendance at, or participation in, AMWA’s Annual Conference and its 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.

TRAVEL INFORMATION Be sure to check out San Antonio’s welcome to AMWA including dining discounts, area maps, travel information and more!

Our host city of San Antonio, Texas is rich in history, and vibrant with multi-cultural flair. The conference hotel, the Grand Hyatt San Antonio, is just steps away from the downtown River Walk, the Alamo, The Tower of Americas, and the River Center Mall. Sign up sheets will be available at the registration desks for you to join fellow attendees while sightseeing.

San Antonio International Airport hosts over 30 non-stop domestic and international destinations. The airport is an approximately 20-minute drive from the Grand Hyatt San Antonio. The San Antonio International Airport has more information for passengers to help you navigate your trip.

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hotel and location information AMWA Headquarters Hotel and conference location:

Stay at the AMWA Headquarters Hotel and receive these benefits:

Grand Hyatt San Antonio 600 East Market Street San Antonio, TX 78205

• AMWA conference events are under one roof at the beautiful Grand Hyatt San Antonio • Complimentary internet access in sleeping rooms ($10/night value) • Access to heated rooftop lap pool, 24 hour fitness center, and full service business center • Walking distance to the famous San Antonio River Walk, the historic Alamo, breathtaking views at the Tower of the Americas, and shopping at the Rivercenter Mall ©Hyatt Corporation

• Perk’s Coffee Cafe (24 hours), Ruth’s Chris Steak House, and Bar Rojo located in the hotel • Book by September 1 to secure the discounted hotel room rate of $179 per night (plus tax)

Book your hotel reservation now at: https://resweb.passkey.com/go/ammedwriters2015

About the Conference Hotel

Rate: $179.00 per night plus tax. Rate includes wireless Internet access in sleeping rooms.

Networking. Sometimes important networking happens when you least expect it. With most AMWA Annual Conference Attendees staying at the AMWA headquarters hotel, you never know who you might run into in the elevator, hallway, or restaurant.

Discounted room rate is available until September 1, 2015.

Questions? annual_conference@amwa.org

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Convenience. All AMWA conference activities will be taking place in the Grand Hyatt San Antonio. The hotel is located by the picturesque San Antonio River, just minutes from the River Walk, Alamo, shopping, dining, golfing, and more. The hotel is also a short distance from the airport.

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full program schedule

KEY and designations

Key to Schedule

AMWA Certificates

OS Open session (includes Topic Seminars, Panel Presentations, How-To, Pro/Con Debates, and Hands-on Demonstrations) WS Workshop T Thursday Roundtable Discussion with breakfast S Saturday Roundtable Discussion with lunch Golden Apple Award Recipient for excellence

in teaching in the AMWA education program

You may earn an AMWA Certificate by enrolling in the certificate program and earning 8 workshop credits. For the Essential Skills certificate, you may earn credits through in-person workshops and/or self-study workbooks. For specialty certificates, Composition and Publication, Concepts in Science and Medicine, and Regulatory and Research, you may earn credits through in-person workshops. For these specialty certificates, up to 2 workshop credits can be from electives in other content areas. Certificate program details can be found beginning on page 48.

AMWA’s 2015 Annual Conference offers workshops, open sessions, and roundtables.

• Workshops are 3-hour intensive, small group training programs designed to enhance the skills of medical communicators. Workshop participation requires an additional fee, and workshops are approved for credit toward an AMWA certificate.

Workshop Designations

The titles of credit workshops are followed by designations (in parentheses) and permanent workshop number.

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.

• Open sessions are informational sessions that are included with your registration. There is no additional fee or registration required.

ES Essential Skills B Business CP Composition and Publication RR Regulatory and Research SM Concepts in Science and Medicine ADV Advanced G General ED Educators EW Editing/Writing FL Freelance PH Pharmaceutical PRAM Public Relations/Advertising/Marketing

• 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.

Program Tracks

We have assigned tracks to open sessions to make it easier to find the sessions of most interest and relevance to you and your professional goals. In addition, we have assigned tracks to workshops this year. Tracks include 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.

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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.

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full program schedule

wednesday/THURSDAY WEDNESDAY, SEPTEMBER 30

THURSDAY, OCTOBER 1 7:00 AM–5:30 PM

8:30–11:30 AM

Medical Writing Certification Examination (additional application process and fees are required.)

Conference Registration and AMWA Information Desk Open 7:30–8:45 PM

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.

9:00 AM–12:00 PM BELS Examination (Registration is available through the Board of Editors in the Life Sciences, www.bels.org.)

1:00–4:30 PM Exhibitor and Poster Setup 1:30–4:00 PM

T-01 • Rational Prescribing of Antibiotics during Influenza Season Studies show that antibiotics are overprescribed for influenza. In this roundtable we will discuss the following related topics: comprehensive CDC prescribing recommendations and patient education material; identifying irrational prescripting pressures and patient interventions to avoid unnecessary antibiotic use; use of pertinent, clinically useful information with repetitive messaging for long term content retention; and positive reinforcement for alternative patient education and adoption of a “wait and watch” approach to episodic viral infections.

2014–2015 AMWA Board of Directors Meeting 2:00–7:00 PM Conference Registration and AMWA Information Desk Open 5:00–6:30 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 mustdo 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.

Attendee Level of Experience: New to the Field (0-5 years) Mary B. Sebas, CNP, Nurse Practitioner, Mayo Clinic Health Systems, Fairmont, MN

T-02 • HTAs & AMCP Dossiers: Find Out What They Are In 5 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. During this roundtable, an overview will be provided on what these documents are, who requests them, how they are 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 payerrelated documents!

6:30–8:00 PM

Welcome Reception in the Exhibit Hall, Posters on display Join your colleagues in a fun and informal setting with hors d’oeuvres and a cash bar. It’s also your first chance to visit with exhibitors and browse the posters. (See page 20 for the list of poster presentations.)

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full program schedule

thursday welcome to share their own favorite self-education tools and practices!

Attendee Level of Experience: New to the Field (0-5 years) Eleni Samaras Allen, PharmD, Senior Manager, Global Medical Writing, Amgen, Inc., Apex, NC

Attendee Level of Experience: New to the Field (0-5 years) Tim Peoples, MA, ELS, CMPP, Medical Writing Manager, Amgen Inc., Thousand Oaks, CA

T-03 • Quick-Start Marketing for Freelance Success Marketing is one the biggest challenges for many freelance medical writers. With a few high-impact, low- or no-cost marketing tools, you can start marketing your business effectively in days and rise above the crowd of freelances. Learn how easy it is to develop and use your elevator pitch, business card, email signature, LinkedIn profile, and AMWA Freelance Directory listing, and to build your AMWA network.

T-06 • Standing-up for a Healthier You “Standing-up for a Healthier You” literally means standing-up while you work. I will present compelling research that shows that a sedentary life is detrimental to our longevity and the benefits of standing vs. sitting during our workday. I will share my personal experience to help change your world and we will discuss solutions to take you on your path to a healthier you!

Attendee Level of Experience: New to the Field (0-5 years) Lori De Milto, MJ, Owner, Lori De Milto Writer for Rent LLC and Author, “The Mighty Marketer: Your Guide To Making More Money as a Freelance Medical Writer,” Sicklerville, NJ

Attendee Level of Experience: All Levels of Experience Jodi Pollock, Principle Medical Writer, Inventiv Health, Apex, NC

T-07 • Nobody Ever Wins in a Twitter Fight!

Just like in the real world, in social media misunderstandings will occur. Conflict happens! After all, it is just like any other form of communication, perception is controlled by the recipient. If you communicate with people, regardless of how, one day (and usually when you least expect it) miscommunication will occur and if we are not careful it can quickly escalate to conflict. In this session we will examine some well-known social media conflicts, share tips on how to avoid conflict and discuss some tools and techniques we can use to minimize the damage when one does occur.

T-04 • So You Want To Do a Webinar Seems like everyone is producing and presenting webinars these days. And why not? They are a great way to highlight your expertise and bring in customers (and, sometimes, revenues). In this roundtable, you will learn 3 reasons for hosting a webinar and what’s involved in producing, presenting, and marketing one.

Attendee Level of Experience: All Levels of Experience Debra Gordon, MS, President, GordonSquared, Inc, Williamsburg, VA

T-05 • Learning Medicine One Day at a Time: Tools and Techniques for Medical Research and Communications Newbies How do I drink from a fire hose? You may be asking yourself this question as you try to transition into medical writing after a career in humanities or even academic science. Come to this roundtable to learn how to cultivate knowledge and plan a program in medical research, communication, and trends; daily or for projects—even without prior knowledge. We will discuss how to teach yourself about what is new in these fields and what has been established as industry best practices (eg, ethics, publication planning, guidelines, EBM). Discussants are

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Attendee Level of Experience: All Levels of Experience Larry Lynam, MS, Principal, The Lynam Group, LLC, Coral Springs, FL

T-08 • Grantsmanship 101 While securing external funding to support academic research is expected, few investigators receive grant writing training during their graduate studies. NIH funding rates in recent years have consistently been less than 20%. Having a basic understanding of the tools (or grantsmanship) successful grant writers use can give a competitive edge to any grant. We will discuss how persuasive language, typographic changes, figures, tables

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Thursday

T-12 • 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.

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.

Attendee Level of Experience: New to the Field (0-5 years) Kristina Wasson-Blader, Scientific Editor, University at Buffalo, Buffalo, NY

Attendee Level of Experience: All Levels of Experience Norman Grossblatt, ELS(D), Chevy Chase, MD

T-09 • The Process of Job-Hunting Job-hunting is a process. It requires a significant amount of up-front preparation, knowledge about where to look, and how to handle interviews. Every person has unique abilities (eg, therapeutic specialty, bilingual, etc) and challenges (just starting out, can’t relocate, etc). Come talk to your peers about experience and strategies!

T-13 • Science Education Resources for Humanities Majors Many medical writers come to the profession from a humanities background. This roundtable discussion will focus on online and offline resources that these writers can use to help educate themselves about various medical and scientific topics. Free websites and several helpful books will be discussed; please be prepared to offer your own examples of websites and other resources you find useful.

Attendee Level of Experience: All Levels of Experience Kelleen Flaherty, MS, Adjunct Assistant Professor, University of the Sciences in Philadelphia, Jamison, PA

T-10 • How to Retain Author Voice When Editing Medical writers must walk a difficult line between improving a document and rewriting a document.

Regardless of how many changes we make, the author’s voice must be retained. Join this roundtable to discuss best practices for editing to retain author voice. Bring your own suggestions and learn from others.

Attendee Level of Experience: New to the Field (0-5 years) Daryl McGrath, M.A., Web Content Specialist, National Cancer Institute, Lafayette, LA

T-14 • 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. Topics will include starting off on the right foot with new authors, when to seek help from authors to understand their research, how to avoid becoming overwhelmed, becoming more confident about contacting authors to ask questions or discuss manuscript issues.

We will also discuss strategies for meeting authors’ needs while juggling multiple projects.

Attendee Level of Experience: All Levels of Experience Kerri Hebard-Massey, PhD, Medical Writing Sr. Manager, Amgen Inc, Thousand Oaks, CA

T-11 • Mining Medical Information in 0 to 60 How daunting is it for you to take on a new topic to write about, especially when it is a medicine-related topic?

During this session, we will go through the actual process of obtaining and organizing information about a topic that is new to you in the shortest possible time. And we will compare the validity, usefulness, and accessibility of different sources. Ideas for how to figure out what you already know and what you need to find out will be discussed.

Attendee Level of Experience: All Levels of Experience Sunita Patterson, Scientific Editor, Department of Scientific Publications, The University of Texas MD Anderson Cancer Center, Houston, TX

T-15 • Editing a Winning CME Grant Proposal If you’re an experienced writer of needs assessments who’s curious about how what you write gets folded into a larger CME grant proposal, this roundtable is for you.

Attendee Level of Experience: All Levels of Experience Lori Rochelle, PhD, Senior Medical Writer, InventivHealth Clinical, Durham, NC

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full program schedule

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Thursday

We’ll start off with a short didactic presentation to set the stage, then move into a discussion of best practices in grants editing, which is sure to also lead to a discussion of current issues and hot topics in the world of commercially supported CME. Since we’re writers, we’ll also talk about crafting a winning reference list—including the growing use of multi-media literature references, including videos recorded at medical meetings. We’ll also discuss tips and tricks for crafting catchy titles and key phrases that grab a grant reader’s attention.

successful integration of a medical writer to the team.

Attendee Level of Experience: All Levels of Experience Yeshi Mikyas, PhD, ELS, CMPP, Director of Medical Communications, MedImmune, Gaithersburg, MD

T-18 • Dos and Don’ts of Manuscript Writing Do you ever wonder why writing IMRAD style (introduction, materials and methods, results, and discussion) manuscripts is challenging or how to decide what information goes into which section of the manuscript? This roundtable will focus on three practical tips for writing each section of a manuscript including the abstract and conclusion. Sample manuscripts will be selected from the published literature and used as examples to identify the main points and common errors of each section. This roundtable is intended for writers with at least 1 year of experience writing manuscripts. Participants should bring their manuscript writing questions and prepare for a lively and practical discussion.

Attendee Level of Experience: All Levels of Experience

Attendee Level of Experience: Advanced (10 or more years) Donald Harting MA, ELS, CHCP, CME Specialist, MCM Education, Newtown, PA

T-16 • Working with Interns: The View from Both Sides Have you considered trying to find an intern to help you with your writing or editing, but don’t quite know how to go about finding interested and qualified candidates?

Have you ever had an intern who just didn’t work out as well as you’d hoped? Are you planning to be an intern and wanting to make that experience the best it can be?

Come join us as we discuss the best practices of student internships: dos, don’ts, and how-tos, including setting expectations before and during an internship, from the perspective of both the employer and the intern. Come share your experiences,find out what others have done, and learn how to build mutually beneficial mentor-mentee relationships that last long after the internship!

Andrea Gwosdow, PhD, President, Gwosdow Associates Science Consultants, Arlington, MA

T-19 • Utilizing the Medical Writer as a “Knowledge Holder” for Efficient and Strategic Regulatory Document Development Medical writers can play a critical role as the “knowledge holder” of multidisciplinary content generated during years of drug development. Utilizing this resource can result in improved efficiencies in the document development process and an overall increase in the quality of strategic regulatory submissions. The roundtable discussion will use a real-world case study to illustrate the value of the medical writer at preparing an orphan drug application, presented at a level appropriate for writers new to the process. Other examples of strategic regulatory documents will be discussed where medical writers can bring advantages to sponsors and potential benefit to patients with rare diseases.

Attendee Level of Experience: All Levels of Experience Christina B. Sumners, MS, Communications Specialist, Texas A&M College of Veterinary Medicine & Biomedical Sciences, College Station, TX

T-17 • Onboarding a New Medical Writer: Best Practices A successfully onboarded writer will have a clear definition of what constitutes success in being a productive member of the team and a timeline for getting there.

Onboarding done well results in increased efficiency, productivity, confidence, credibility, compliance, and greater work quality. This roundtable is a discussion of the people and processes that are important in the onboarding and

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Attendee Level of Experience: New to the Field (0-5 years) Mark Bowlby, PhD, Associate Principal Regulatory Writer, Synchrogenix, Malvern, PA

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Thursday T-20 • Get Published: Perspectives from the AMWA Journal Editor If you are new to medical writing and editing or a veteran communicator, the AMWA Journal may have a spot that could be filled by you. The Journal has a variety of article types, including conference coverage, features, instructional reports, book reviews, and original research. Come discuss the possibilities of how you can contribute to a publication that AMWA is seeking to improve with each new issue. The editor will also discuss publishing opportunities available through other professional societies.

T-23 • Exploring the Cataclysmic Shift in the Cancer Paradigm “What is cancer?” is a deceptively simple question. But with one in three of us destined for a personal cancer experience, it is important to explore the concepts and frequently controversial issues surrounding malignancy.

After a brief ten minute introduction, this roundtable discussion will focus on dissecting the new paradigms and answering your questions regarding the origin and nature of malignancy, the phenomenal progress in the treatment of cancer, and issues surrounding cancer prevention as well as the cost and access to care. We will explore some of the major themes at the forefront of cancer research and provide a conceptual framework to integrate and translate this new information.

Attendee Level of Experience: All Levels of Experience Victoria White, MA, ELS, Editor, AMWA Journal, Tampa, FL

T-21 • Introverts and Extroverts: Communicating Effectively Together Introvert or extrovert, it can be hard when you work with different personalities. This roundtable discussion will talk about the struggles of different personalities working together and discuss ways to improve communication between personality types for a better, more successful working relationship.

Attendee Level of Experience: All Levels of Experience Janet Macheledt, MD MS MPH, Medical Oncologist/ Hematologist, Methodist Oncology Partners, Bellaire, TX

T-24 • Transitioning Into Medical Writing for Diverse Professionals Are you a new or transitioning professional looking to break into the field or advance your career in medical writing? Medical writers come from diverse backgrounds.

By leveraging shared experiences, you too can overcome hesitations and recognize your unique medical writing skillset. Join us to discuss strategies for promoting individual and team success, formulating your personal value proposition, and identifying growth opportunities.

Attendee Level of Experience: All Levels of Experience David Clingan, Senior Medical Editor, inVentiv Health Clinical, Helotes, TX

T-22 • Trends and Transformations in CME: Interpreta­ tions and Implications for Medical Writers and Editors As the CME landscape continues to change, it is critical that professionals performing CME writing (eg, conducting gap analyses, writing educational grant requests) stay abreast of trends in CME. This session will feature a Certified Healthcare CPD Professional and medical writers discussing educational, regulatory, and industry trends that inform how CME activities are planned, developed, implemented, and evaluated. Relative emphasis on these topics will be guided by results of a survey of medical writers. We will discuss the identified trends and formulate strategies to address them.

Attendee Level of Experience: All Levels of Experience Catherine Cadogan, BFA, Senior PB Clinical Writer, GE Healthcare, Waukesha, WI

T-25 • Evolution of Expanded Access Programs: Treatment for Patients who have Run Out of Options The expanded access treatment programs at BMS bridge the gap between clinical development and regulatory approval. The evolution of these expanded access programs allows patients to receive treatment under compassionate use who have run out of treatment options and are ineligible for enrollment in a clinical trial. The clinical paradigm of expanded access is evolving at BMS where

Attendee Level of Experience: Intermediate (5-10 years) Karen Overstreet, EdD, RPh, FACEHP, CHCP, ELS, Senior Director, Medical Affairs, Imedex, LLC, Raleigh, NC

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we no longer seek to collect the same magnitude of clinical data but to streamline data collection and operations to provide treatment to these patients-in-need. This session will discuss proposed modifications to model documents, templates, intake, review, and request processes that will foster increased efficiency with the goal of enabling easier access to drug treatment for patients who have run out of options. Expanded access programs bridge the treatment gap for patients and differences from clinical studies requires a reevaluation of clinical research practices.

ness 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.

Attendee Level of Experience: New to the Field (0-5 years) Darryl Z. L’Heureux, PhD, Medical Writer, MedSciTech Writing, Philadelphia, PA

Opening GENERAL Session This session features a welcome from AMWA President Karen Potvin Klein, MA, ELS; the presentation of the President’s Award; and the Alvarez Award Address, “Take Them on a Journey,” by Jay Ingram.

Attendee Level of Experience: All Levels of Experience Anita Misra-Press, Freelance Medical Writer, Portland, OR

9:00–10:30 AM

T-26 • Using Project Management as the Locus of Change in Medical Writing As project issues become more complex and the desire to meet the goals and objectives of a project becomes paramount, knowing how to implement the needed processes and controls without hurting morale, stifling creativity, or alienating clients becomes key to project success. The three topics covered in this presentation are to help you influence the outcome of a project. The first topic is how to measure project status. The second topic is how to communicate project status to key stakeholders. The final topic is how to implement and manage change while a project is still ongoing. These topics will be illustrated with examples taken from the clinical study report development process.

10:30–11:00 AM 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.

11:00 AM–12:00 PM OS-01 • Medical Writing for Digital Learning Programs [Technology/Social Media, Writing for Professional Audiences]

Digital learning on tablets (iPad, droid), smartphones (iPhone, Droid), APPs, and web has become the way to train adults in the workplace. Medical writers with expertise in digital learning are in demand in this rapidly evolving field. This session will focus on what digital learning is, the typical process for development and the role of the medical writer on healthcare and life science digital learning programs, software, and resources for medical writers who wish to up-skill in digital learning (eg, eLearning, mobile learning, APPs).

Learning Objectives: 1. Describe the latest methodologies digital learning methodologies. Recognize the role of the medical writer in developing digital learning

Attendee Level of Experience: All Levels of Experience Thomas Purcell, MSPM, Principal Medical Writer, PAREXEL, Saline, MI

T-27 • 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 busi-

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characteristics. The survey serves as the most methodical and analytical resource for setting and negotiating salaries between employees and employers and additionally for setting and negotiating fees between freelances/consultants and their clients. AMWA makes improvements with each succeeding survey, adding new questions to capture the interests of the profession while also retaining key questions to compare current results with those of past surveys.

Learning Objectives: For all medical communicators, whether entry level or experienced, the professional will gain knowledge of the current demographic qualities, professional characteristics, and associated salaries/ incomes. The information is also helpful for employers to set salaries, as well as for the employee to leverage the information in negotiating salaries. Additionally, the independent professional can also leverage the information to negotiate fees as a contractor for hire.

Suggested Level of Experience: All Levels of Experience Michelle Nolin, CPLP, Learning Strategist, Marshallberg, NC

OS-02 • THE BUDAPEST WORKING GROUP: A 2-Year Collaboration to Develop a Practical User’s Manual for Clinical Study Reports and Protocols [Regulatory] The Budapest Working Group consists of experts in E3, E6, and protocols and clinical study reports tasked with reviewing the ICH E3 and ICH E6 guidelines. Stakeholders (eg, FDA, EMA, Health Canada, DIA, CDISC) are also involved to ensure that the anticipated recommendations address the needs of the broadest possible audience. An open-access publication was recently released and gives further details on the objectives and 2-year project plan Learning Objectives: 1. To provide an update on the status of the ICH E3 and ICH E6 reviews. 2. Attendees will have insight into the review and adjudication processes entailed in the Budapest Working Group process.

3. Attendees will appreciate the proposed insights and recommendations that apply to the ICH E3 and ICH E6 guidelines, with respect to clinical study report and protocol preparation. 4. Attendees will understand how the recent clinical trial reporting disclosure policies affect the clinical study report.

Suggested Level of Experience: All Levels of Experience Susan Bairnsfather, CEO, EPharmaTech LLC, Shreveport, LA

OS-04 • Producing High Quality Documents within Shrinking Timelines [Regulatory, Relevant Skills] Quality regulatory documents are critical for the success of a program, but it is hard to maintain a high level of quality in the face of ever-shortening timelines. With careful planning, however, a writer can produce a quality document even under time constraints. In this session, we will present strategies for template use, writing a first draft, managing cycles of review and revision, and performing Quality Control review, with the ultimate goal of producing documents with the highest level of quality.

Learning Objectives:1. Establish and maintain quality from writing through review and revision of regulatory documents. 2. Understand the importance of the Quality Control review. 3. Improve the quality of a regulatory document through Quality Control review.

Suggested Level of Experience: All Levels of Experience Aaron B. Bernstein, PhD, Director, Global Submissions, Synchrogenix Information Strategies, Inc., Bloomfield, NJ Art Gertel, President and Principal Consultant, MedSciCom, LLC, Lebanon, NJ

OS-03 • AMWA Salary Survey 2015 - Presentation of Statistical Analyses [Professional Development] As the leading professional organization for medical communicators, AMWA’s salary survey is internationally recognized as the largest survey of medical writing and editing professionals. Reaching for the highest standards, the survey collects the most medical writer and editor respondents and the analysis includes the most indepth scrutiny of demographic qualities and other professional

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Suggested Level of Experience: All Levels of Experience Ann M. Winter-Vann, PhD, Senior Medical Writer and Consultant, Whitsell Innovations, Inc, Chapel Hill, NC Rhea Grill, Associate Manager, Medical Writing QC, Celgene Corporation, Summit, NJ

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OS-05 • Speed Networking [Professional Relationships] This session allows you to get acquainted with colleagues in a structured way. You’ll sit with another person at a small table and have 5 minutes to share your professional and personal interests. Then one of you will quickly move to the next table. This is NOT job-hunting; participants will not be divided between job seekers and hiring managers. Rather, this session fosters serendipity—you never know whom you’ll meet, what interests you’ll share, and whether you might develop a business relationship or friendship! Bring lots of business cards. Please arrive on time and stay for the whole session. Both newer and established members are encouraged to attend. Limited to 60 participants.

Zombie Rules and Shibboleths: Exploring a Few Contested Rules of English Grammar

S. Daniel Siepert, MA, Medical Editor, RTI Health Solutions, Research Triangle Park, NC Kate Lothman, Medical Editor, RTI Health Solutions, Research Triangle Park, NC Amy Martin, MA, Director, Editorial Services, RTI Health Solutions, Research Triangle Park, NC

Social Media and Patient Communication: Writing and Research Strategies to Increase Online Impact

Angela Johnson, MSE, PMP, Senior PB Clinical Writer/English Department, GE Healthcare/Texas Technical University, Waukesha, WI

Best Practices in Writing CME Needs Assessments

Suggested Level of Experience: All Levels of Experience Anita Misra-Press, PhD, Medical Writing and Editing, Freelance, Portland, OR

Donald Harting MA, ELS, CHCP, CME Specialist, MCM Education, Newtown, PA Ruwaida Vakil MS, Principal, ProMed Write LLC, Somerset, NJ

12:15–1:45 PM

Human Abuse Liability (HAL) Studies: Not Your Traditional Phase I Studies

Lunch in the Exhibit Hall (included with registration fee) Visit with the Poster Presenters

Rona Claire Grunspan, MD, Manager of Medical Writing–Early Development Services, PRA Health Sciences, Lenexa, KS

PRESENTED POSTERS

Quality of Patient Medication Information Handouts Associated With Commonly-Prescribed Drugs

Adapting Pediatric Protocol Designs from Existing Adult Data and Study Templates

Kimberly Koon, Pharm D, Student, University of the Sciences, Seattle, WA

Jennifer K. Strickler, BA, Medical Writer, Premier Research Group, Leander, TX Thomas Laage , MD, MPH, Director, Regulatory Medical Writing and Product Development Consulting, Premier Research Group, Philadelphia, PA Charlene Sanders, MD, Vice President, Global Regulatory Affairs, Compliance, & Pediatric Strategic Consulting, Premier Research Group, Philadelphia, PA

Establishing an Editorial Process: Tools for Success

Alyssa Dallas, BA, Associate Director, Editorial Services, RTI Health Solutions, Research Triangle Park, NC Amy Martin, MA, Director, Editorial Services, RTI Health Solutions, Research Triangle Park, NC

Rational Prescribing of Antibiotics during Influenza Season

Taming the Beast: Managing Complex, Multi-Author Edits

Mary B. Sebas, CNP, Nurse Practitioner, Mayo Clinic Health Systems, Fairmont, MN

Kate Lothman, BA, Medical Editor, RTI Health Solutions, Research Triangle Park, NC Amy Martin, MA, Director, Editorial Services, RTI Health Solutions, Research Triangle Park, NC

AMWA Salary Survey 2015–Presentation of Statisical Analyses Susan Bairnsfather, CEO, EPharmaTech LLC, Shreveport, LA

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Thursday Evolution of Expanded Access Programs: Treatment for Patients who have Run Out of Options

OS-07 • Grant Writing Careers: A New Frontier for Medical Writers [Relevant Skills] With funding increasingly short, there is a dramatic rise in the need for professional grant writers in both academic and non-profit settings. Writing winning grant proposals can be challenging: they require strategic sales writing coupled with well-crafted medical/technical writing; they are highly competitive; and they often come with structural and timing requirements that can be daunting. Whether looking to expand your freelance “reach” by offering grant writing services or becoming a grant professional full time, this session will offer guidance on finding grant writing opportunities that best fit your skills and experience. We will also detail how best to apply your skills to so that you can succeed in this role and improve the next grant proposal you write or edit. Covering both academic and nonprofit grant writing, this session will help you will discover the opportunities, resources, and key writing techniques you need to be successful in this competitive arena.

Learning Objectives: 1. Discover what you need to know about an organization to write an effective grant.

2. Gather the necessary detail and articulate your project idea in a convincing manner. 3. Learn the components of an effective grant and ways to present them most convincingly. 4. Understand the emerging job market for grant writing/editing in academia. 5. Identify required skillsets for academic grant personnel. 6. Prepare and submit fundable grants in an academic environment using toolkit.

Darryl Z. L’Heureux, PhD, Medical Writer, MedSciTech Writing, Philadelphia, PA Amy Fesmire, MS, ELS, Manager, Medical Data Operations, Bristol-Myers Squibb, Plainsboro, NJ Susan Dalton, Associate Director, Bristol-Myers Squibb, Plainsboro, NJ

2:00–3:30 PM OS-06 • Unlock the Secrets to Freelance Success [Freelance, Professional Development]

Whether you’re a new (or aspiring) freelance or have some experience but want to be more successful, in this panel presentation you’ll learn how to maximize your opportunities and minimize your challenges. Find out how three seasoned medical writers built successful freelance businesses—and how you can too. Get practical insights and tips on topics such as the essential ingredients of a successful freelance business, making more money through marketing, bad behaviors that can sabotage your business, and more. We’ll have plenty of time for Q&A. Learning Objectives: 1. You will be able to find freelance writing opportunities while managing challenges in your freelance business. 2. You will be able to develop and implement a marketing plan to attract clients and develop your business. 3. You will be able to identify and avoid behaviors that make clients dissatisfied.

Suggested Level of Experience: New to the Field (0-5 years) Lori De Milto, MJ, Owner, Lori De Milto Writer for Rent LLC and Author, “The Mighty Marketer: Your Guide to Making More Money as a Freelance Medical Writer,” Sicklerville, NJ Cynthia L. Kryder, MS, CCC-Sp, Medical Communications Specialist, Author, “The Accidental Medical Writer”, Phoenixville, PA Brian Bass, President, Bass Global, Inc., Author, “The Accidental Medical Writer,” Robbinsville, NJ

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Suggested Level of Experience: All Levels of Experience R. Michelle Sauer, PhD, ELS, CRA, Vice President of Education and Development, International Medical Relief, Cypress, TX Zach Bohannan, MA, ELS, Senior Technical Writer, MD Anderson Cancer Center, Houston, TX Kathi L. Whitman, MA, Senior Medical Writer/Project Manager, Intermountain Healthcare, Salt Lake City, UT

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OS-08 • What’s the Deal with DILI? Reporting DrugInduced Liver Injury and Signals from Routine Liver Function Tests [Regulatory] Drug-induced liver injury (DILI) is the most frequent cause of safety-related withdrawal of marketed drugs and an important economic and public health issue. This session will cover basic concepts of DILI, identify routine clinical liver function tests used to detect DILI, and discuss the FDA’s draft guidance on premarketing clinical evaluation of DILI. The session is designed for inexperienced to moderately experienced regulatory writers, but the concepts covered will also be applicable to authors of journal articles and other medical communicators. Session attendees will gain a clear, knowledgeable context in which to report and interpret safety data related to DILI. Learning Objectives: 1. You will know the routine liver function tests used to identify DILI. 2. You will understand the FDA’s draft guidance on the premarketing clinical evaluation of DILI. 3. You will gain the context to review, interpret, and report routine liver function test results as signals of a drug’s potential for causing DILI.

and editor in the editing process.

Suggested Level of Experience: New to the Field (0-5 years) Tabatha L. Cannata, Divisional Editorial Lead, Envision Pharma Group, Southport, CT Elizabeth L. Cassell, Divisional Editorial Lead, Envision Pharma Group, Southport, CT Hilary A. Flora, Divisional Editorial Lead, Envision Pharma Group, Southport, CT

2:00–5:00 PM WS-01 • Advanced Data Presentation: Tables, Graphs, and Charts (ADV) #701 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.

Suggested Level of Experience: Intermediate (5-10 years) Jude Richard, ELS, Senior Medical Writer, INC Research, Austin, TX Jul Lea Shamy, PhD, Clinical Program Manager, Mindshare Medical, Elmsford, NY

Janet Novak, PhD, Senior Editor, Memorial Sloan Kettering Cancer Center, New York, NY

OS-09 • Too Much Red Pen? Understanding Levels of Editing [Editing, Professional Relationships] In this session, a team of editors identify, define, and provide examples of the three main levels of editing used in medical publications. The editors will share best practices on determining the level of edit needed, managing the communication and expectations with the writer, and how best to identify suggested edits. In addition, we will provide examples on how to improve the working relationship when a misunderstanding of the level of editing needed has occurred.

Learning Objectives: 1. Identify and define levels of editing in medical publications. 2. Provide examples of the various levels of editing. 3. Discuss the roles of the writer

AMWA’s 75th Annual Conference

WS-02 • Outlining for Writers and Editors (ES/EW/FL) #2007 This workshop is designed for beginning and 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. Sue Hudson, Medical Writing Associates, Simi Valley, CA Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Nashville TN

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Thursday WS-03 • Punctuation for Clarity and Style (ES/G) #2008 Designed for communicators whose professional writing experience and grammatical savvy range from minimal to moderate, this discussion of the most useful punctuation rules and options—from the serial comma to the dash—will focus on emphasis, variety, and consistency.

Medically-oriented examples, including many sent in by participants, will be discussed. APPROXIMATE HOMEWORK TIME: 3-5 HOURS.

conveyed through lecture, practical examples, case studies, and discussion. APPROXIMATE HOMEWORK TIME: 3 HOURS. Eve J. Wilson, PhD, ELS, CHCP, Medical Writer/Editor & CME Consultant, MORPHOS Medical Education, LLC, Bowie, MD Marcello A. Morgan, MD, CHCP, Sr. Medical Writer, IMNE, Warren, NJ

WS-06 • Writing Abstracts (CP) #3019 This workshop is intended for medical editors and writers with up to 5 years’ experience. An overview of the purpose and structure of the medical or scientific abstract will be given, with emphasis on abstracts prepared for publications. Registrants will evaluate and write abstracts based on precourse materials and workshop exercises. APPROXIMATE HOMEWORK TIME: 3-5 HOURS.

Helen E. Hodgson, Ph.D., Westminster College, Salt Lake City, UT

WS-04 • Statistics for Medical Writers and Editors (ES/G) #2010 This workshop is designed for participants who have little or no background in statistics. Elementary statistical concepts needed to understand medical and scientific articles will be covered, including types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and Student’s t test. Emphasis will be placed on understanding statistical presentations and on reporting statistical information, not on calculations or mathematical explanations. APPROXIMATE HOMEWORK TIME: 3 HOURS.

Thomas Annesley PhD, University of Michigan, Ann Arbor, MI Yeshi Mikyas, PhD, ELS, CMPP, Director, Medical Communications, MedImmune/AstraZeneca, Gaithersburg, MD

WS-07 • Basics of Human Anatomy and Physiology (SM/EW/PH) #3503 This workshop is suitable for the beginning and moderately experienced writer or editor. The workshop leader will offer basic knowledge of human anatomy and physiology through lecture and discussion. Organization of the human body, from molecular to system levels, will be covered. APPROXIMATE HOMEWORK TIME: 2 HOURS.

Bart Harvey, MD, PhD, Associate Professor, University of Toronto, Ontario, Canada

WS-05 • Preparing CME Materials: Concepts, Strategies, and Ethical Issues (CP/EW/FL) #3012 Beginning to advanced medical writers are often involved in the preparation of educational-needs assessments, learning objectives, and content for continuing medical education (CME) activities. Writers need to have a working knowledge of how and why CME is developed, the main stakeholders in the process, and the roles of sponsors and supporters. In view of the ethical issues that may arise when pharmaceutical companies provide CME grant support, writers need to be familiar with the guidelines set by the Accreditation Council on Continuing Medical Education, the American Medical Association, and other organizations. These important topics will be

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MaryAnn Foote, PhD; MA Foote Assoc, Westlake Village, CA

WS-08 • Evidence-Based Medicine (sm) #3509 This introduction to evidence-based medicine (EBM) is intended for medical communicators at any level who have an interest in EBM as it applies to critical appraisal of the medical literature, production of higher-quality medical documents, or job opportunities involving EBM. The workshop will be taught through an informal lecture format with a group-learning activity and time for discussion. Topics will include what EBM is, the context in which it developed, how it is practiced, tools of EBM, study design, levels of evidence, bias, and the standards

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movement. Statistics associated with EBM will not be covered in depth. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.

workshop will not address technical aspects of assembling an eCTD for electronic submission. APPROXIMATE HOMEWORK TIME: 1.5-3 HOURS.

Tamara Ball, MD; Principal Medical Writer; inVentiv Health; Asheville, NC

Nancy R. Katz, Ph.D., President & Principal Medical Writing Consultant, Illyria Consulting Group, Inc., Soda Springs, CA

WS-09 • Pharmacokinetics in Clinical Practice and Drug Development (SM) #3519 This course will focus on the four pharmacokinetic parameters—absorption, distribution, metabolism, and elimination of drugs. Key terms and basic calculations will be addressed in primarily a lecture format.

Pharmacogenetics, as related to pharmacokinetics, will be briefly discussed. This course will discuss how PK is studied in different types of clinical studies: first-inhuman, single- and multiple-ascending dose, comparative bioavailability (bioequivalence, food effects), drug interactions. What is the 80-125% confidence limit? What is Pop PK? APPROXIMATE HOMEWORK TIME: 3 HOURS.

WS-11 • Writing the Investigator Brochure (RR/PH) #4015 This workshop is intended for moderately experienced to advanced writers in the pharmaceutical industry who want to improve their understanding of the investigator brochure (IB). The workshop leader will focus on the regulatory and informational needs of the audience and how to use best practices to communicate information on the drug. Relevant regulations will be reviewed, and required topics discussed. The evolution of the IB from phase 1 to phase 4 will be elucidated. A discussion will focus on how to prepare an IB using subject matter experts. APPROXIMATE HOMEWORK TIME: 3-4 HOURS.

Gayle Nicholas Scott, PharmD, ELS, Scientific Solutions, Envision Pharma Group, Southport, CT Shirley Teng, PhD, Scientific Solutions, Envision Pharma Group, Southport, CT

Jane Stephenson, PhD, MBA. Director of Medical Writing, Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield CT

WS-12 • Understanding the Principles of Kaplan-Meier Analysis (RR) #4017 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 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 HOURS.

WS-10 • The Electronic Common Technical Document (RR/PH) #4004 This workshop is appropriate for regulatory/medical writers who have minimal or moderate experience in preparing documents for 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 eCTDbased 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, and guidelines; and best practices for writers on an eCTD-based submission team. Please note that this AMWA’s 75th Annual Conference

Sybille Eibert, PhD, Team Leader/Senior Medical Writer, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany Thomas Schindler, PhD, Head Medical Writing Europe, Boehringer Ingelheim Pharma GmbH&CoKG, Biberach, Germany

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Thursday WS-13 • Fundamentals of Ethics and Practical Applications (RR) #4020 Ethical considerations associated with conducting clinical research are critical to the understanding of consequences of participation as a subject in clinical studies. The foundations of ethical principles, societal perspectives, and fundamentals of patient protections 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 a thorough review of relevant ethical issues with respect to clinical research trials and will include group discussions on major ethical considerations of provided 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, as well as the institutions that have been created to safeguard patient rights and considerations. Throughout, the workshop will focus on the central ethical issue in clinical study conduct: to ensure subject safety and wellbeing. (NOTE: This workshop or Ethics of Communicating Regulated Drug Development Activities is required to complete the Regulatory and Research specialty certificate.)

APPROXIMATE HOMEWORK TIME: 2 HOURS. Note this workshop will end at 5:30 PM. Art Gertel, Principal Consultant, MedSciCom, LLC, Lebanon, NJ

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2. Understand how text organization may affect comprehension elsewhere in the world.

Suggested Level of Experience: New to the Field (0-5 years) Barbara Jungwirth, Writer, Translator, reliable translations llc, Brooklyn, NY

OS-11 • CMC 101: Introduction to the Chemistry, Manufacturing, and Controls Sections of a Regulatory Dossier [Regulatory] Have you ever wondered what exactly goes into the chemistry, manufacturing, and control (CMC) section of a dossier and why those sections are typically the last piece ready for the submission? This session will provide a highlevel overview of the information required in the Quality or Module 3 CTD sections. An example timeline will illustrate the steps required to acquire this information and timing associated with generation of that data. Understanding the challenges faced by CMC can help teams understand, anticipate, and potentially even adapt to potential hurdles that may be encountered during CTD section preparation of the submission process.

Learning Objectives: The attendees will learn about the types of CMC information that are provided in a dossier, how that information is organized in CTD Module 3, and the basic differences in requirements between clinical trial and marketing applications.

Suggested Level of Experience: Intermediate (5-10 years) Robin Robinett, PhD, Director, Merck, West Point, PA

3:30–4:00 PM Beverage Break in the Exhibit Hall

OS-12 • Basics of Content Writing for Medical Practices and Hospitals [PR/Marketing] Medical writing for healthcare practices and hospitals is a burgeoning market. More consumers than ever are finding their providers and seeking advice through Google searches. Many hospitals and private practices are responding to this need by developing online content marketing strategies. In this course, you will learn the basics of content marketing as it applies to these healthcare service environments. Key concepts covered in this class will include: Search engine optimization (SEO), blogging, content management and creation, social media distribution, internet and medical writing style, as well as ethics and HIPAA concerns.

4:00–5:00 PM OS-10 • What to Consider When Writing for Global Audiences [Writing for Lay Audiences] Will your text be distributed internationally? In this session we will look at some of the potential problems you should watch out for and techniques for avoiding them.

You will gain hands-on experience with adapting your writing to non-US audiences. A list of further resources and a discussion of how to evaluate your text in an international context will round out the session.

Learning Objectives: 1. Handle writing issues, such as word choice, grammar and text organization, that may be difficult to understand for non-native English speakers. www.amwa.org

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Learning Objectives: 1. Learn about opportunities for medical writers in the growing field of content marketing. 2. Learn the components of a solid online content strategy that is effective, ethical and HIPAA compliant. 3.

Learn how to create high-value, evidence-based medical content that attracts patients and search engines.

7:30–8:45 AM Breakfast with the Exhibitors (included with registration) A good breakfast paves the way for an engaged mind!

Enjoy a complimentary continental breakfast with the conference exhibitors.

Suggested Level of Experience: New to the Field (0-5 years) Amy Rogers, MD, Copyblogger Certified Content Marketer, Coffee Break Medical Marketing, McKinney, TX Bliss Mishler, MS, PT, Freelance Medical Writer, Editor, Content Manager, Coffee Break Medical Marketing, Volcano, HI

7:30 AM–4:00 PM Conference Registration and AMWA Informa-tion Desk open

OS-13 • The Art of the Editor’s Query: Effective Strategies for Seeking Clarity [Editing] This seminar, designed for new or intermediate manuscript editors (0-10 years’ experience), focuses on effective strategies for querying authors about unclear text.

We will review the role of the editor, with emphasis on teaching authors to consider the needs and expectations of the target reader. The discussion will include real-life examples showing different approaches to seeking clarity from authors in a succinct, diplomatic, and time-saving manner. Strategies to avoid common pitfalls will be described. Attendees will be encouraged to share examples from their own experience.

Learning Objectives: 1. Attendees will learn how to diplomatically approach authors about unclear passages through succinct queries that prompt unambiguous responses. 2. Attendees will develop time-saving strategies to develop queries and update text. 3. Attendees will bond over the shared experience and triumphs associated with powering through puzzling text.

Exhibit Hall open, Posters on display 9:00–10:30 AM

OS-14 • Scope of Medical Communications [Professional Development; Relevant Skills]

This session is designed for those who want to learn about the wide range of settings for medical communicators. The panel features medical communicators 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.

Suggested Level of Experience: New to the Field (0-5 years) Jennifer Grodberg, PhD, RAC, Regulatory Affairs Consultant, Carlsbad, CA Scott Kober, MBA, Principal, MedCaseWriter, Philadelphia, PA Sarah Zimov, PhD, President and Principal Medical Writer, New Hope, PA Cyndi Carr, PhD, Manager, Medical Writing, Ventana Medical Systems, Inc., Tucson, AZ

Suggested Level of Experience: All Levels of Experience June Oshiro, PhD, MS, ELS, Editor, Mayo Clinic, Rochester, MN

6:00 PM

Meet in Hotel Lobby to Depart for Chapter Dinners Meet up with your chapter colleagues before heading out for dinner.

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OS-15 • Bridging the Gap Between Regulatory Approval and Market Access: An Introduction to Health Technology Assessments (HTAs) [Writing for Professional Audiences]

Payers and policymakers are challenged by the need to balance access to new medical technologies against the

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OS-17 • Medical Writing in the Next 75 Years: The Untold Stories of Animal-to-Human Translational Research [Health and Medicine] Medical discoveries made in animals are often reported as the equivalent of human research when, in reality, cures touted in animal models rarely materialize into effective therapeutics for human patients. Experts will address these translational concerns (“From animal bench to human bedside: the untold stories”) and discuss how we can overcome these limitations with novel human-based technologies (“Tackling the translational gap: humanized research”). In their “quest toward brilliance”, attendees will learn why they should and how they can address human relevance, the pragmatic approach to medical writing in the next 75 years.

Learning Objectives: Attendees will learn about the difficulties in translating animal research into human medicine and how this can be overcome by humanrelevant research methods. Attendees will also learn how to address human relevance, the pragmatic approach to medical writing in the next 75 years.

impact that these technologies have on the cost of medical care. Health Technology Assessments (HTAs) are used by payers and policy makers to assess the clinical efficacy, safety, and cost-effectiveness of a specific therapy within a particular disease area. The aim of this session is to provide attendees with an overview of HTAs including their purpose and overall structure, an introduction to key components such as health economics and systematic review methodology, as well as specific examples of HTAs from different healthcare systems.

Learning Objectives: 1. Explain basic health economics and outcomes research (HEOR) concepts. 2. Describe the role of HTAs in drug formulary decision-making in the U.S. and abroad. 3. Define specific techniques for writing HTAs. Suggested Level of Experience: All Levels of Experience Eleni Samaras Allen, PharmD, Senior Manager, Global Medical Writing, Amgen, Inc., Apex, NC Marcia Reinhart, PhD CMPP, Principal, Tantalus Medical Communications, Victoria, BC

OS-15 • It’s Not You; It’s Me: Dealing with Critique and Criticism [Professional Development] Medical writing is also a domain where feedback, critique, and criticism are common. Obtaining substantive comments and actionable feedback can be challenging, especially while endeavoring not to appear defensive or strident. Initially, this presentation will address how to handle the unique challenges of criticism and critique.

It will focus on strategies for keeping cool, obtaining information, and maintaining team rapport. Then, audience members will be engaged to share their stories and “workshop” solutions. This will be an interactive session for writers at all levels.

Learning Objectives: 1. Discuss the challenges of critique and criticism. 2. Detail strategies for handing comments in constructive fashion and obtaining actionable feedback. 3. Strategize about how to create a better rapport and outcome with even the most challenging teams.

Suggested Level of Experience: All Levels of Experience Charu Chandrasekera, PhD, Director of Laboratory Science, Physicians Committee for Responsible Medicine, Washington, DC Thomas Hartung, MD, PhD, Professor and Director, The Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD

9:00 AM–12:00 PM WS-14 • Synergy of Style, Substance, and Audience (ADV) #711 This workshop is for experienced wordsmiths who wish to participate in a group discussion about what constitutes style in science writing. As participants consider elements of style in various sample manuscripts, they will also determine how to modify style to make material more effective for different target audiences. Throughout the workshop, the combined effects of substance and style will be covered in discussion and problem-solving units. Recommendation: Completion of the Effective Paragraphing workshop and Organizing the Biomedical Paper workshop or have at least 5 years’ experience as

Suggested Level of Experience: All Levels of Experience Robin Whitsell, BA, BPh, President, Whitsell Innovations, Inc, Chapel Hill, NC

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Friday WS-17 • Bibliographic Resources for Medical Communicators (ES/G) #2002 This workshop is an introduction to bibliographic resources in the medical sciences. The goal of the workshop is to enable workshop participants to become “information literate.” The primary focus will be on integrating different types of sources and search engines into the process of searching the peer-reviewed medical literature.

PubMed, PubMed Central, and Google Scholar searches will be conducted during the workshop, and analyzed and discussed. Information concerning free access to information will also be included. APPROXIMATE HOMEWORK TIME: 3 HOURS.

the primary author or substantive editor of biomedical manuscripts. APPROXIMATE HOMEWORK TIME: 6 HOURS. Elliott Churchill, MS, MA, President, A World of Words, Tucker, GA

WS-15 • Understanding Sample Size and Study Power (ADV) #729 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 Medical Writers and Editors and Observational Research Design.

Participants would also benefit from having taken Risks and Ratios. APPROXIMATE HOMEWORK TIME: 3 HOURS.

Joan N. Nilson, Research/ Data Analyst, UPMC Health Plan, Pittsburgh, PA

WS-18 • Tables and Graphs (ES/G) #2011 The workshop leader will cover definitions and uses of tables and graphs, as well as guidelines for preparing and editing them. The focus of the workshop, designed for the beginner, is the preparation of tables and graphs that are usable, that communicate, and that are appropriate for the situation. Participation is encouraged as we evaluate problematic tables and graphs. APPROXIMATE HOMEWORK TIME: 3-4 HOURS.

Bart Harvey, MD, PhD, Associate Professor, University of Toronto, Ontario, Canada

Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach VA

WS-16 • Basic Grammar I (ES/G) #2000 Thorough knowledge of parts of speech is truly basic to good writing and editing. This workshop focuses entirely on parts of speech and their use in the sentence. Types of nouns and pronouns, verb tense, pronouns and case, phrases and clauses (with special emphasis on verbals and on noun, adjective, and adverb clauses), and the types of sentences are some of the primary topics that the workshop covers. Information in this workshop is, in essence, basic to every other AMWA workshop. If you took Basic Grammar II and Usage for credit, you can still take this workshop for credit if you need additional grammar review. APPROXIMATE HOMEWORK TIME: 2 HOURS.

WS-19 • Launching a Freelance Writing Career (B/FL) #2504 The workshop leader will explore strategies for starting a freelance writing or editing career. Included will be an overview of myths about freelancing and discussion of the pros and cons of a freelance career. Participants will learn strategies for finding clients, marketing their skills, preparing contracts, estimating project time, and setting fees. After completing the workshop, participants will be equipped with resources and tools for finding a path to success in freelancing. This workshop is most appropriate for those contemplating a move into freelancing and those who have been freelancing for less than a year.

APPROXIMATE HOMEWORK TIME: 2 HOURS.

Jude Richard, MA, ELS, Senior Medical Writer, INC Research, Austin, TX

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Eleanor Mayfield, ELS, ELM Communications, Pittsburgh, PA

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Friday WS-20 • Ethical Standards in Medical Publication (CP/EW/PH) #3004 This workshop is required for individuals working to earn the Composition and Publication specialty certificate.

In this workshop, intended for novices and moderately experienced writers and editors, the leader will examine ethical issues in scientific publication. Participants will discuss essential publication guidelines and existing ethical standards while highlighting controversial and unresolved issues. Authors’ editors, journal editors, and writers who participate in the creation of manuscripts often have conflicting perspectives on authorship, duplicate publication, conflict of interest, and peer review; these perspectives will be examined. APPROXIMATE HOMEWORK TIME: 3 HOURS.

dynamics, 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, BCPS, CMPP, Principal Medical Writer, Envision Pharma Group, Southport, CT

WS-23 • Ethics in Communicating Science and Medicine (SM) #3524 This workshop is required for individuals working to earn the Concepts in Science and Medicine specialty certificate. 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.

Andrea R. Gwosdow, Ph.D., President, Gwosdow Associates Science Consultants LLC, Arlington, MA Ann L. Davis, Global Publication Advisor, Bristol-Myers Squibb, Princeton, NJ

WS-21 • Proofreading: Strategy for Document Quality Control (CP/EW) #3013 Proofreading is the final—and often underappreciated— step in producing professional documents. This introductory or refresher workshop focuses on proofreading as a strategy for document quality, distinct from writing or copyediting. More than catching typos, proofreading strategies include achieving consistency, sharpening attention to mechanical errors, and identifying and correcting production and layout issues. Standard proofreading practices and electronic proofreading methods will be discussed. Participants will learn to train both the mind and the eye to determine what to correct, query, or ignore. APPROXIMATE HOMEWORK TIME: 2-3 HOURS.

Tamara Ball, MD; Principal Medical Writer; inVentiv Health; Asheville, NC R. Michelle Sauer, PhD, ELS; Vice President of Education and Development; International Medical Relief; Cypress, TX

WS-24 • Regulatory Aspects of the Drug Development Process (RR/PH) #4010 This workshop is designed for novices to the pharmaceutical industry. Participants will learn about and discuss the drug development process with special emphasis given to regulatory and reporting requirements.

Specifically, the workshop details the history behind drug regulation, the contents and maintenance of an Investigational New Drug Application (IND), Good Clinical Practice (GCP), the phases of human clinical trials, and the most recent regulations impacting drug development. The discussion will draw upon US, European, and

Hope J Lafferty, AM, ELS, Hope Lafferty Communications, Nashville, TN

WS-22 • Drug Interactions (SM/EW/PH) #3508 Drug interactions can be beneficial as well as harmful.

The workshop leader will address the hows and whys of drug interactions—good and bad, pharmacokinetic and pharmacodynamic mechanisms, basic explanations of key concepts of pharmacokinetics and pharmacowww.amwa.org

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International Conference on Harmonisation (ICH) guidelines and regulations. APPROXIMATE HOMEWORK TIME: 3-4 HOURS.

to build narrative composition skills. APPROXIMATE HOMEWORK TIME: 3-4 HOURS. Sara Ewing, BSN, RN, President, Accurate Biomedical Communication, LLC, Yardley, PA

Aaron B. Bernstein, PhD, Director, Global Submissions, Synchrogenix, Bloomfield, New Jersey Yeshi Mikyas, PhD, ELS, CMPP, Director, Medical Communications, MedImmune/AstraZeneca, Gaithersburg, MD

10:30–11:00 AM Beverage Break in the Exhibit Hall 11:00 AM–12:00 PM

WS-25 • Summarizing Clinical Efficacy Data for an NDA (RR) #4013 This workshop is appropriate for regulatory/medical communicators who are moderately experienced in writing clinical regulatory documents. The teaching 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 (SCE). 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.

OS-18 • Journal Submissions: An Editor’s Point of View [Editing, Writing for Professional Audiences] What do journal reviewers and editors look for when deciding to accept a paper for publication? Why are some manuscripts quickly rejected and others returned to the author for revision? Experience suggests that very often, a few minor changes can increase a manuscript’s chance of initial acceptance or result in a request for minor revisions for a paper based on nonclinical or clinical results (eg, clinical study report). The traditional sections of original research papers will be discussed (IMRaD format), and common pitfalls will be highlighted.

The participants will be provided with examples and suggestions for improving each section of the journal article.

This session is geared for writers with 3-5 years of experience.

Learning Objectives: Upon completion, participants should be able to identify the standard parts of a journal article and the information that should be contained in each section. Participants should learn the most common errors seen by journal editors and reviewers that impede immediate acceptance for publication.

Marijke H Adams, PharmD, PhD, President, MH Adams & Associates, Inc, Davie, Florida, USA Thomas Schindler, PhD, Head Medical Writing Europe, Boehringer Ingelheim Pharma GmbH&CoKG, Biberach, Germany

WS-26 • Composing Narratives for Safety and Adverse Event Reporting (RR) #4023 NEW WORKSHOP! Effective narrative composition is a skill. Well-written narratives are cohesive, concise, and clear. This workshop is appropriate for inexperienced to moderately experienced writers who want to develop the skills needed to compose top quality narratives. Key elements in safety reporting, correct use of medical language, and organization of data for a well-written narrative will be covered.

Best practices and realistic constraints will be discussed. This workshop will include interactive exercises

AMWA’s 75th Annual Conference

Suggested Level of Experience: All Levels of Experience MaryAnn Foote, PhD, Owner, MA Foote Associates, Westlake Village, CA

OS-19 • Don’t Believe Everything You See, Hear, or Read: The Art of Critical Thinking [Relevant Skills] “Local Mom Makes Plastic Surgeons FURIOUS!” Evaluate data and present it using clarity, accuracy, precision, consistency, relevance, sound evidence, good reasons, depth, breadth, and fairness, and learn to identify bias, prevarication, weasel-wording, manipulation, and a

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Friday variety of logical fallacies. You probably already have these skills—now you can put a name to them. These are critical skills for effective communication, particularly in science and medicine. (Spoiler: local mom is not making plastic surgeons furious.)

Learning Objectives: 1. Define critical thinking. 2. Explain how scientific literacy is an applied form of critical thinking. 3. Identify the major logical fallacies.

medical communicators the ability to establish a brand and their expertise in a particular area. A well-developed content marketing strategy is key in today’s social media landscape. Publication of good content, in addition to a creative distribution style, can bring your marketing campaign to the next level. This open session will discuss how to use three key social media platforms for a traditional approach to marketing along with new trends that can set you as a job seeker or your business apart from others.

Learning Objectives: 1. Learn the importance of a strong content marketing strategy for social media marketing.

2. Evaluate the technology each platform has to offer regarding capabilities, content, and visual marketing strategies. 3. Explore novel social media tools available to assist in your marketing campaign.

Suggested Level of Experience: All Levels of Experience Kelleen Flaherty, MS, Adjunct Assistant Professor, University of the Sciences in Philadelphia, Jamison, PA

OS-20 • Leaving Manual Referencing Behind: Embracing EndNote [Technology/Social Media] Learn how to make an easy transition to EndNote from manual referencing. This session will describe the roles and responsibilities around EndNote for writers and editors and introduce the role of an EndNote coordinator.

It will show writers how to take a large EndNote library created from a literature search and develop a smaller library that is easier to use while writing. The session will demonstrate how to use EndNote’s Cite While You Write function, add citations to a document, and update the bibliography. Please bring your laptop (PC or Mac) with EndNote software installed. There will be a Q&A session at the end.

Learning Objectives: 1. Develop a workflow around using EndNote among writers, editors, and EndNote coordinators. 2. Create working libraries from larger literature search libraries. 3. Use Cite While You Write to manage references in a document

Suggested Level of Experience: Intermediate (5-10 years) Ruwaida Vakil, MS, Principal, ProMed Write LLC, Somerset, NJ Jennifer Minarcik, MS, Freelance Science and Medical Writer, Moorestown, NJ

12:15–1:45 PM

AMWA Sablack Awards Luncheon (complimentary) Named after AMWA’s first executive director, Lillian Sablack, this event recognizes the outstanding service and contributions of medical communicators.

Presentation of the Student Scholarship Award, sponsored by the University of the Sciences in Philadelphia.

Presentation of 2015 Fellowships: 2015 Fellowship Committee chair, Douglas Haneline, PhD, will present Fellowship Awards to Catherine Magill, PhD, Katharyn Spiegel, PhD, and Kristina Wasson-Blader, PhD, for significant contributions to the goals and activities of the association.

Presentation of the Harold Swanberg Distinguished Service Award and Swanberg Address: Bart Harvey, MD, PhD, 2015 Swanberg Committee Chair, will present the Swanberg Distinguished Service Award, given for distinguished contributions to medical communication and the medical profession, to Helen Hodgson, PhD, who will then present her award address.

Suggested Level of Experience: New to the Field (0-5 years) Margaret Mathes, Medical Editor, RTI Health Solutions, Research Triangle Park, NC

OS-21 • Using Social Media for Marketing: Harnessing the Power of Twitter, LinkedIn, and Beyond [PR/Marketing]

Social media is a powerful tool for marketing. There are various key social media platforms that allow

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Friday Learning Objectives: Participants will be able to identify the most important components of a successful kick-off meeting, will learn the general guidelines for attending and hosting a kick-off meeting, and will be able to improve communication with clients by adequately preparing and following up on the kick-off meeting.

2:00–3:30 PM OS-22 • Amending Protocols and Informed Consent Forms: Don’t Let a Minor Protocol Amendment Become a Major Headache [Regulatory] Protocols lay the groundwork for performing clinical trials. Amendments to the protocol can set in motion a cascade of changes in performing the trial, including the need to update the informed consent document. Writers must be able to understand how even a small change can cause ripples throughout the study and its associated documents. Following this session, attendees will have the tools necessary to comprehensively evaluate and record changes to the protocol and implement them in the informed consent document. Furthermore, attendees will learn best practices for navigating sticky situations across multifunctional teams.

Learning Objectives: Participants will learn to 1. Identify changes in protocol amendments that result in changes to consent documents 2. Incorporate and document changes to consent documents 3. Manage document versions during review and finalization

Suggested Level of Experience: New to the Field (0-5 years) Kelly Kilibarda, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc., Chapel Hill, NC Jenilyn Virrey, PhD, CMPP, Medical Writing Senior Manager, Amgen Inc., Thousand Oaks, CA

OS-24 • Transforming Perceptions of Medical Writers from Coal to Diamonds—If Superman Can Do it, so Can We! [Ethics] Medical communicators are often perceived as spin doctors who do not add value to the publication process.

Using ghostwriting as a model, this session will review existing and new guidelines, as well as survey data showing that awareness of guidelines is associated with ethical behavior. Although the prevalence of unethical behavior appears to be decreasing, it has not yet disappeared.

This session will engage the audience in a dialogue about how to best transform our image from being puppets to serving as vectors for integrity.

Learning Objectives: 1. To be knowledgeable about resources for applicable guidelines, especially the new Good Publication Practice for Communicating CompanySponsored Medical Research guideline (GPP3). 2. To be familiar with the results of the series of surveys of writing practices conducted by AMWA/EMWA. 3. To be able to list three ways for medical writers to become vectors for integrity.

Suggested Level of Experience: New to the Field (0-5 years) Kent Steinriede, MS, Medical Writer II, Parexel International, Bala Cynwyd, PA Halima Chutkan, PhD, RAC, Medical Writer and Consultant, Whitsell Innovations Inc., Whitsell Innovations Inc., Durham, NC

OS-23 • How to Successfully Host and Effectively Participate in Kick-Off Meetings (KOMs) [Relevant Skills]

Effective client communication is a cornerstone of a successful medical writing career. The first encounter with a client is critical to establishing trust, rapport, and a productive working relationship. Ensure that clients are delivered a polished first impression of you/your company by exercising the best practices for attending/ hosting a kick-off meeting (KOM). This presentation will cover the purpose, phases, and general discourse of a successful KOM. Attendees will learn how to prepare for and follow-up on KOMs. Additionally, attendees will learn how to effectively participate in a KOM and will be introduced to the basics of hosting a KOM.

AMWA’s 75th Annual Conference

Suggested Level of Experience: All Levels of Experience Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach, VA Teresa Peña, Exec Director, Medical Publications, Worldwide Medical, Bristol-Myers Squibb Company, Princeton, NJ Michael Platt, CMPP, President, MedVal Scientific Information Services, LLC, Skillman, NJ Art Gertel, President and Principal Consultant, MedSciCom, LLC, Lebanon, NJ

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OS-25 • Develop Your Pricing Prowess: Simple HowTo’s for Freelance Writers [Freelance, Relevant Skills] Pricing is a big challenge for most freelancers. In this interactive seminar, learn how to establish prices that honors the value of what you offer. You’ll discover ways to overcome your discomfort around pricing, and take effective action. You’ll also find out how to virtually eliminate competition. This interactive seminar will make your decisions about pricing easier.

Learning Objectives: 1. To learn principles for pricing authentically to reflect the value that you offer 2. To discover ways to make friends with your discomfort around pricing issues 3. To create action steps that you can implement right away to adjust your pricing and increase income in your business.

WS-28 • Basic Grammar II and Usage (ES/G) #2001 Customary practice, particularly with respect to language, can sometimes lead to unclear writing, especially when the writer is tempted to use informal or nonstandard English. This workshop builds on Basic Grammar I by reviewing additional grammatical topics and by discussing some aspects of English usage. Correcting dangling or misplaced modifiers, using who or whom and which or that, making subjects agree with verbs, writing clear comparisons, and choosing the correct word are topics addressed in this workshop. 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.

Suggested Level of Experience: All Levels of Experience Ursula Jorch, MSc, MEd, Founder, Jorch Consulting LLC, Asheville, NC

Anne Marie Weber-Main, Associate Professor of Medicine, University of Minnesota Medical School, Minneapolis, MN Loretta Bohn, Senior Editor/Writer, RTI International, Research Triangle Park, NC

2:00–5:00 PM WS-27 • Current Trends in Drug Regulations (ADV) #728 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 to discuss in detail recent and future regulatory changes (eg, EMA’s Policy 70: Publication and Access to Clinical Trial Data ) 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 presenting during the workshop.

APPROXIMATE HOMEWORK TIME: 4-5 HOURS.

WS-29 • Elements of Medical Terminology (ES/G) #2005 This workshop, which will consist mainly of lecture and exercises, is designed primarily for beginning medical writers with little or no medical background. Participants will learn how to understand the meanings of medical terms by identifying Latin and Greek word components.

APPROXIMATE HOMEWORK TIME: 3 HOURS. Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, Texas Terry Anderson, Alan Edits, LLC, Silver Spring, MD

WS-30 • Sentence Structure and Patterns (ES/G) #2009 Through lecture and examination of flawed and improved sentence examples, participants will consider the main elements of sentence construction, accommodation to the reading process, and the management of emphasis— all with a view toward matching structure to purpose.

APPROXIMATE HOMEWORK TIME: 2-5 HOURS.

Aaron B. Bernstein, PhD, Director, Global Submissions, Synchrogenix, Bloomfield, NJ

Michael Schneir, Professor, Herman Ostrow School of Dentistry of the University of Southern California

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WS-31 • Establishing Style: Exploring and Developing In-House Guides (ES) #2013 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 2 major style manuals (eg, Chicago Manual of Style, AMA) for the pre-course assignment. APPROXIMATE HOMEWORK TIME: 2-3 HOURS.

WS-34 • Usage: Choosing the Right Word for the Job (CP) #3027 Designed for moderately-experienced medical communicators, this workshop focuses largely on words that are commonly misused in medical writing. We will discuss what is considered correct usage in the academic medical literature (mainly according to AMA style), as well as choosing words for maximum precision and conciseness.

The workshop is partly in a lecture format and will also involve group exercises. Time will be allotted for participants to raise their own questions about usage. It is recommended that participants take the Basic Grammar and Usage workshop before taking this one. APPROXIMATE HOMEWORK TIME: 1 HOUR. Stephen N. Palmer, PhD, ELS, Senior Scientific Medical Writer, Texas Heart Institute, Houston, TX

Nicole Van Hoey, PharmD, Freelance Writer/Editor, Arlington, VA

WS-32 • Organizing the Medical Paper (CP/EW/FL) #3010 This basic workshop for authors, authors’ editors, and journal editors will examine the principles of organizing original research reports for publication. Lecture, discussion, and exercises will be used to teach participants about the function and content of each section of a biomedical paper, the value of clarity within each section, and the importance of tying each of the sections together. APPROXIMATE HOMEWORK TIME: 2-3 HOURS.

WS-35 • Introduction to the Endocrine System (SM) #3513 Endocrinology is the study of hormones and the glands that produce them. This workshop is intended for medical writers and editors with little or no background in endocrinology. Participants will learn the basic anatomy and physiology of the various endocrine glands in the human body (eg, the hypothalamus, pituitary, adrenal glands, reproductive organs) and the different types of hormones that these glands produce. The workshop leader will also discuss the wide-ranging effects of hormones on different body systems, their mechanism of action, and methods for measuring hormone levels.

APPROXIMATE HOMEWORK TIME: 2-3 HOURS.

Thomas Annesley PhD, University of Michigan, Ann Arbor, MI

WS-33 • Plain Language (CP/EW) #3011 In this basic workshop, writers and editors with little experience in preparing health information materials for readers with limited literacy skills will learn about writing plainly for this audience (at reading levels for grades 4 through 8). After a discussion of the principles of plain language, participants will practice writing plainly in a variety of exercises. APPROXIMATE HOMEWORK TIME: 3 HOURS.

Joanne M. McAndrews, PhD, Freelance Medical Writer, St. Louis, MO

WS-36 • Introduction to Basic Bacteriology (SM) #3525 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

Sharon Nancekivell, Freelance, Guelph, Ontario, Canada

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WS-39 • Writing Clinical Evaluation Reports for Medical Devices (RR) #4022 While the FDA extensively overhauls its submission process for medical devices, American companies are seeking European market authorization. However, there are major differences between the review and approval processes for medical devices in the European Union compared to the FDA. In particular, a Clinical Evaluation Report is required for all European medical devices (excluding diagnostics). The workshop leader will provide practical advice for gathering and reporting valid clinical evidence in compliance with European Directive 2007/47/EC. This workshop is appropriate for regulatory/medical communicators who are moderately experienced in writing clinical regulatory documents (such as Final Clinical Study Reports, Integrated Summary of Safety, Integrated Summary of Efficacy). Experience performing critical appraisal of the scientific literature also would be helpful. Knowledge of medical device development would be especially helpful. APPROXIMATE HOMEWORK TIME: 3 HOURS.

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.

APPROXIMATE HOMEWORK TIME: 3 HOURS Thomas Gegeny, MS, ELS, Stakeholder Engagement Leader, Clear Pharma, Westport, CT Rebecca Jarvis, Senior Medical Writer, Envision Pharma Group, Southport, CT

WS-37 • Investigational New Drug Applications (RR/ PH) #4008 This workshop is intended for writers with little or no experience in preparing documents for regulatory applications. The leader will cover the essential components of an investigational new drug application, FDA regulations, and the reviewers’ needs. Participants will also gain an understanding of the writer’s contribution to the quality of an electronic submission. Requirements and available online sources will be included. APPROXIMATE HOMEWORK TIME: 3–4 HOURS.

Felicia R Cochran, BS, PhD, CMPP, Principal Clinical Evidence Specialist, Medtronic, PLC, Minneapolis, MN

3:30–4:00 PM Beverage Break in the exhibit hall 4:00–5:00 PM

Jennifer Grodberg, PhD, RAC, Regulatory Affairs Consultant, Carlsbad, CA

OS-26 • Bridging the Gap: Enriching Relationships in Our Increasingly Diverse Workplace [Professional

WS-38 • Reporting Correlation and Regression Analyses (RR/G) #4011 This workshop approaches the topics of correlation and linear regression analysis conceptually, not mathematically, so you will not learn to run a regression analysis, but you will learn to interpret and report the results. This workshop is suitable for new and experienced medical writers and editors, but it is recommended to take the Statistics for Medical Writers and Editors workshop beforehand or have the equivalent knowledge.

APPROXIMATE HOMEWORK TIME: 3 HOURS.

Development, Professional Relationships]

Successful professionals understand the importance of adapting to an increasingly diverse workplace. This session addresses differences that can keep us from communicating effectively. We will first explore the inherent differences in approaches that men and women use and how they impact their communication and leadership styles. Next, we’ll address culture diversity with tips and strategies that may increase mutual understanding and greater sensitivity. Differences in body language and business practices will also be discussed. Our goal is to identify and eliminate or minimize impact from ineffective

Jane Neff Rollins, MSPH, Arnell Communications, Montrose, CA

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behaviors and unspoken rules that may be sabotaging one’s ability to connect and influence.

Learning Objectives: 1. Understand how men and women use language differently. 2. Be aware of perceptions and judgments that mislead and sabotage open communication. 3. Identify generalizations that influence our daily interactions. 4. Adapt a communication style that encourages collaboration, regardless of culture or gender.

Finally, we will emphasize the rewards in satisfaction and new knowledge that come with working in the international medical arena.

Learning Objectives: 1. Learn the special needs and expectations of non-native English-speaking authors.

2. Learn about opportunities for working with editing firms worldwide. 3. Learn about special business needs (billing, money transfer, and collecting) of dealing with international clients.

Larry Lynam, Principal, The Lynam Group, LLC, Coral Springs, FL Roz Usheroff, President, The Usheroff Institute, Inc, Palm Beach, FL

Suggested Level of Experience: New to the Field (0-5 years) William Brown MD, Prof Medicine Emeritus, Univ Colorado School of Medicine, International Medical Editing Service LLC, Denver, CO

OS-27 • 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.

Learning Objectives: 1. The audience will be able to organize their abstract into a poster to create an effective presentation. 2. The audience will learn effective methods for presenting their text and figures and for organizing their poster layout for national meetings.

OS-29 • Web-Based Literature Review Software for Systematic Reviews and Clinical Evaluation Reports– Saving Lives through Software [Regulatory, Technology/ Social Media]

Anyone conducting structured literature reviews will tell you that they are a lot more work than most people think. While review principles and methods are straight forward, dealing with the sheer volume of data, references and management overhead can take years off of your life. Web-based review software has been around since 2001, but has really taken off in the past 6 years.

These tools bring the promise of automation, transparency, speed and auditability. This hands-on session will discuss web-based review methodologies and provide hands on experience with the DistillerSR and DistillerCER literature review software platforms. Please make sure to bring your laptop.

Learning Objectives: 1. You will be able to setup and run a web-based systematic review. 2. You will learn how to conduct reference screening and data extraction in a web-based system. 3. You will learn how to generate output tables and targeted reference lists.

Suggested Level of Experience: All Levels of Experience Michelle Stofa, BA, Research Communications Manager, Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE

OS-28 • Medical Editing for Non-Native EnglishSpeaking Authors [Editing] The program will advise and assist freelances in editing/ writing for non-native English-speaking authors. We will list foreign firms that employ freelances and give advice about working with those firms; advise editors about special needs and expectations of foreign authors; give advice about pricing, billing, and collecting from overseas clients; warn freelances about scams. We will also discuss matters of etiquette, courtesy, and respect in interactions with authors of various cultures and nationalities.

AMWA’s 75th Annual Conference

Suggested Level of Experience: All Levels of Experience Isabella Steffensen, PhD, President, Thera-Business, Kanata, ON Peter O’Blenis, BCS, MBA, Director, Evidence Partners, Ottawa, ON

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small molecule drugs; how these differences affect the clinical programs for these products; and how these differences ultimately affect the regulatory writer’s work.

Examples of clinical development of therapeutic proteins will be briefly discussed.

Learning Objectives: Upon completion of the program, the attendee will be able to 1. Describe differences between biologics and small molecule therapeutics.

2. Describe how the properties of biologics affect the work of the regulatory writer.

6:00 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 San Antonio. Attendees will be able sign up onsite for a dinearound group and explore the city.

SATURDAY, OCTOBER 2

Suggested Level of Experience: New to the Field (0-5 years) Aaron Van Etten, Regulatory Writer, Independent Contractor, Newbury Park, CA

7:45–8:45 AM Breakfast with the Exhibitors and Passport Prizes Awarded (included with registration) 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.

OS-31 • Beyond the Box: New and Innovative Moneymaking Strategies for Freelances [Freelance] This panel discussion will highlight novel moneymaking approaches for savvy freelancers, including webinars, public speaking, and self-publishing. Three experienced freelancers will discuss their success at earning income beyond writing and editing, including how to get started; how to market yourself; and, simply, how to do it!

Learning Objectives: 1. Describe steps involved in hosting a webinar. 2. Describe the fundamentals of self publishing. 3. Discuss opportunities for earning income as a speaker.

7:45 AM–12:00 PM Exhibit Hall Open, Posters on Display 8:30 AM–3:00 PM Conference Registration and AMWA Information Desk Open 9:00–10:30 AM

Suggested Level of Experience: All Levels of Experience Debra Gordon, MS, President, GordonSquared, Inc, Williamsburg, VA Lori De Milto, MJ, Owner, Lori De Milto Writer for Rent LLC and Author, “The Mighty Marketer: Your Guide To Making More Money as a Freelance Medical Writer,” Sicklerville, NJ Katharine O’Moore-Klopf, ELS, KOK Edit, East Setauket, NY

General Session With McGovern Award Address, Eric Martin Award This session features the presentation of the Eric Martin Award and the McGovern Medal Address, “Retractions, Post-Publication Peer Review, and Fraud: Scientific Publishing’s Wild West,” by Dr Ivan Oransky.

10:30–11:00 AM

OS-32 • Word Master Class: From Expert to Guru

Beverage Break in the exhibit hall

[Technology, Professional Development]

You thought you were an expert in Microsoft Word?

Discover its full potential, and learn how to exploit Word’s functionality to make medical writing more about the content, rather than the formatting. Diving into lesser-known features of Microsoft Word we demonstrate how to achieve easier, more consistent document format-

11:00 AM–12:00 PM OS-30 • What’s Different About Regulatory Writing for Biologics? [Regulatory] The presentation will summarize how biologics, particularly therapeutic proteins, are different from traditional

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ting, providing hints, tips and shortcuts that can easily be put into practice.

Learning Objectives: 1. Take away skills to improve document formatting using Microsoft Word. 2. More easily create professional Word documents. 3. Save time using the style and formatting capabilities available in Microsoft Word.

12:15–1:45 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.

Suggested Level of Experience: Intermediate (5-10 years) Barry Lyne, Vice President Sales, PleaseTech Ltd, Malmesbury, Wiltshire, United Kingdom

S-01 • Yes, You CAN Take a Sabbatical Whether you freelance or work for a company, burn-out is a very real danger. In this roundtable, you hear from a freelancer who burned out, took a sabbatical, and came back to life—and you’ll learn how recognize signs of burnout, and how to plan and execute your own sabbatical.

OS-33 • Managing Through the Storm: How to Successfully Handle a Crisis for Your Company or Client [PR/Marketing] In the day of 24-hour news cycles, crisis communications is an essential element that every company—especially those in healthcare—must consider. Properly responding to a crisis requires an innate understanding of news cycles, potential reporter bias, what news outlets are trying to achieve, as well as how the inner-workings of a client can possibly hinder progress. In this interactive session, participants will learn how to prepare for a crisis before it even occurs, evaluate a burgeoning crisis, guide clients as to how to respond to a crisis, and properly manage a crisis.

Learning Objectives: 1. Compare different types of crises and best practices for how to address them. 2. Identify the three main ways to respond to a crisis, and when to employ them. 3. Empower medical communicators to confidently guide clients through crisis and handle media inquiries.

Attendee Level of Experience: All Levels of Experience Debra Gordon, MS, President, GordonSquared, Inc, Williamsburg, VA

S-02 • Learning Medicine One Day at a Time: Tools and Techniques for Medical Research and Communications Newbies How do I drink from a fire hose? You may be asking yourself this question as you try to transition into medical writing after a career in humanities or even academic science. Come to this roundtable to learn how to cultivate knowledge about medical research, communication, and trends daily or for projects—even without prior knowledge. We will discuss how to teach yourself about what is new in these fields and what has been established as industry best practices (eg, ethics, publication planning, guidelines, EBM). Discussants are welcome to share their own favorite self-education tools and practices!

Suggested Level of Experience: All Levels of Experience Julie A. Johnson, Principal, ZW Consulting, McMinnville, OR

Attendee Level of Experience: New to the Field (0-5 years) Tim Peoples, MA, ELS, CMPP, Medical Writing Manager, Amgen Inc., Thousand Oaks, CA

11:00–11:30 AM Annual Business Meeting All AMWA members are encouraged to attend, to get an update on AMWA from 2014-2015 President, Karen Potvin Klein, MA, ELS, and Treasurer, Christine Wogan, MS, ELS, to witness the passing of the gavel to Stephen Palmer, PhD, ELS, the 2015-2016 President, and to meet the 2015-2016 Executive Committee.

AMWA’s 75th Annual Conference

S-03 • Editing for Pharma Marketing (Advertising) Pharmaceutical advertising is an industry that uses medical writers to edit, write, fact check, and cite their material. We will review a typical pharmaceutical ad that you see in magazines and review how to find references

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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.

Attendee Level of Experience: New to the Field (0-5 years) Cherie Dewar, B.S., President, Hummingbird Medical Communications, California, MD

Attendee Level of Experience: New to the Field (0-5 years) Ruwaida Vakil, MS, Principal, ProMed Write LLC, Somerset, NJ

S-04 • The Social Media Tool Swap Shop Now that you have joined the ever-increasing number of writers who are using various social media platforms in their work and for networking, chances are you are looking for ways to make social media use more efficient and effective. There are many tools available designed to do just that. This is an opportunity to talk with other active social media users and share your experiences as well as learn from theirs. This session provides a forum to discuss successes and to look for solutions so that your social media use is more efficient and your time is more productive.

S-07 • “So, You’re Going to Take the BELS Exam...”

You want to pursue BELS certification, but you’re nervous because you haven’t taken a test since college. Join us to learn more about the exam: format, topics covered, and how to prepare for it. We’ll address your concerns and answer your questions, so that you can approach the exam calmly, ready to demonstrate your expertise in lifesciences editing.

Attendee Level of Experience: New to the Field (0-5 years), 2 years of experience required for candidacy Leslie Neistadt, ELS, Managing Editor, Saint Louis University, St Louis, MO

Attendee Level of Experience: All levels of writing experience welcome, but at least basic use and understanding of social media is helpful.

Larry Lynam, MS, Principal, The Lynam Group, LLC, Coral Springs, FL

S-08 • How to Retain Author Voice when Editing Medical writers must walk a difficult line between improving a document and rewriting a document.

Regardless of how many changes we make, the author’s voice must be retained. Join this roundtable to discuss best practices for editing to retain author voice. Bring your own suggestions and learn from others.

S-05 • The Process of Job-Hunting Job-hunting is a process. It requires a significant amount of up-front preparation, knowledge about where to look, and how to handle interviews. Every person has unique abilities (eg, therapeutic specialty, bilingual, etc) and challenges (just starting out, can’t relocate, etc). Come talk to your peers about experience and strategies!

Attendee Level of Experience: All Levels of Experience Kerri Hebard-Massey, PhD, Medical Writing Sr. Manager, Amgen Inc, Thousand Oaks, CA

S-09 • Journal Selection: Does It Matter in the Electronic Age? You are diligently writing a paper for publication in a biomedical journal and need to identify the best place to publish it. Historically, journal selection determined how widely read your article would be. Today, in the electronic age, nearly everyone has access to nearly every article—so how critical is journal selection? Are journal impact factors important? Do open access journals have the same prestige as print versions? Will the future of

Attendee Level of Experience: All Levels of Experience Kelleen Flaherty, MS, Adjunct Assistant Professor, University of the Sciences in Philadelphia, Jamison, PA

S-06 • From Bench Top 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

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biomedical publishing be entirely open access? What about authors who can’t afford the multi-thousand dollar open access price tags? Join us for a lively discussion of these issues!

Attendee Level of Experience: All Levels of Experience Stephanie Harvard, Medical Writer, Centre for Health Evaluation and Outcome Sciences, Vancouver, BC

S-12 • 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. Creative commons licenses, and the differences between each license, will be discussed. 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 environment and permissions.

Attendee Level of Experience: All Levels of Experience Mary Ann Chapman, PhD, Principal Scientific Communications Writer and President, Visage Communications, Inc., Mead, WA

S-10 • Coverage and Reporting of a Scientific Congress for a Pharmaceutical Company Attending a major scientific congress and writing daily summaries for a pharmaceutical company can seem overwhelming; significant preparation is required to keep the process running smoothly. This roundtable will be a practical guide on how to effectively and efficiently cover and summarize a conference for a pharmaceutical/ biotechnology company. We will discuss the process of preparing, capturing relevant information, and the logistics that are required to produce a useful and relevant publication for the company. Key discussion points: Pre-Conference Preparation, Logistics, Daily Debrief and Information Gathering, Writing Daily Summaries, Overall Meeting Summaries

Attendee Level of Experience: All Levels of Experience Tabatha L. Cannata, Divisional Editorial Lead, Envision Pharma Group, Southport, CT

S-13 • Five Tips to Prevent Your Website from Becoming an Antique Website creation software like WordPress makes it possible to build a website without advanced technical knowledge. However, it is easy to overlook the maintenance requirements. Without proper planning your medical writing website can become an antique. This roundtable will ensure the money invested to launch your business website continues to be worthwhile months and years later. Attendees will discuss the status of their business website, whether it’s in the planning stage or is currently live. They will learn tips to avoid becoming a hostage of their website host, software, or website designer by improving communication skills with IT professionals.

Attendee Level of Experience: All Levels of Experience Albert Y. Rhee, PhD, Global Medical Writing Manager, Amgen Inc., Thousand Oaks, CA

S-11 • Enhancing Patient Centered Care with Patient Decision Aids: How Can Medical Writers Help Optimize Patients’ Use of Medical Information?

A major movement in health care, Patient Centered Care (PCC) invites patients to be active participants in medical decisions. Medical writers are in demand to help develop Patient Decision Aids (PtDA), written support tools that prepare patients for medical decision-making.

Yet research suggests that cognitive biases can affect how patients interpret information in PtDA, leading to decisional errors. How can medical writers design PtDA to optimize patients’ use of medical information? In this roundtable, medical writers are invited to learn about types of medical decisions, discuss PtDA designed to prevent decisional errors, and share strategies for presenting information to patients.

AMWA’s 75th Annual Conference

Attendee Level of Experience: All Levels of Experience Ciranna Bird, M.S., Medical Writer, Freelance, Raleigh, NC

S-14 • Subject: E-mail, Friend or Foe? Since its debuts in the mid-to-late 1970s, e-mail has become an integral part of our lives. It covers all domains of communication, from private conversations to formal FDA notifications. This roundtable interactive discussion will delineate the common attributes of poor versus successful e-mail communication. Also, in our “quest

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saturday toward brilliance,” we will explore how we can hone our skills to compose and send professional, impactful e-mail messages.

ble we will discuss the basics of contracts for freelances: what to include, what to try to avoid, and how to protect yourself. Bring your questions, concerns, and real-life experiences to share.

Attendee Level of Experience: All Levels of Experience Catherine Champagne, PhD, Medical Science Writer and Editor, Education and Training Systems International, Chapel Hill, NC

Attendee Level of Experience: All Levels of Experience Eleanor Mayfield, ELS, Principal, ELM Communications, Pittsburgh, PA

S-15 • Working with Subcontractors At this roundtable session, we will discuss why you might need or want to work with subcontractors, as well as the pros and cons of subcontracting arrangements. The discussion will focus on how to evaluate, choose, train, and monitor subcontractors as well as how to set up contracts and payments. Participants will be encouraged to share their experiences working with subcontractors as well as working as a subcontractor.

S-18 • Writing Nutrition Content for Behavior Change or Adoption This roundtable will address both practical and theoretical Nutrition Education approaches to writing for consumer audiences related to behavior change and behavior adoption of healthy eating. Constructs from various behavior theories will be discussed, including writing examples of approaches that are consistent with dietary change, particular to women, and dietary adoption of healthy eating for their young children.

Attendee Level of Experience: All Levels of Experience Sherri Bowen, MA, ELS, Freelance, Writer, Austin, TX

Attendee Level of Experience: Intermediate (5-10 years) Anne M. Dattilo, PhD, RD, CDE, Associate Director, Nutrition Science, Nestle Infant Nutrition, Florham Park, NJ

S-16 • Converting to a Paperless Office In an age of digital communications, online document editing and e-signatures, reliance on paper-based communications is becoming difficult to sustain. Yet security concerns and legal questions make many of us hesitate to go paperless. In this roundtable, we’ll discuss the pros and cons of digital document management, some strategies and resources for emptying bulging file cabinets, and some examples of individuals and organizations that made the transition.

S-19 • Medical Writing for the Orthopedic Device Industry: How to Get Started in this Fascinating Field The medical device industry as a whole, and the orthopedic device industry in particular, present a ripe opportunity for medical writers. However, for the medical writer wishing to get started in this area, a steep learning curve awaits with regards to anatomy, terminology, and technology. Participants will be provided with a comprehensive handout that will serve as a useful reference that will be presented in an interactive manner to teach the fundamentals of orthopedic medicine. This will be followed by discussion of the major types of medical writing projects required in the medical device industry, including links to websites for further information.Participants will have the opportunity to share their medical device experience and stimulate group discussion and learning.

Attendee Level of Experience: All Levels of Experience Amy D. Stephenson, MA, Senior Content Strategist, Waggener Edstrom Communications, New York, NY

S-17 • Get It In Writing–Contracts for Freelancers As the saying goes, an oral contract isn’t worth the paper it’s written on. Written agreements (contracts) help both freelance medical writers and their clients have clear expectations about projects: the scope of work, what materials the client will provide to the writer, what the writer will deliver to the client, the timeline, the price, what happens when complications arise. At this roundta-

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Attendee Level of Experience: All Levels of Experience William S. Pietrzak, PhD, President, Musculoskeletal Publication and Analysis, Inc., Warsaw, IN

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S-20 • Pediatric Informed Consent: Do They Understand?

Thousands of children participate in clinical trials each year. Like adults, they give consent or assent, but what does that mean? How do we know that they are volunteering and understand that they can dissent? As writers of consent forms, protocols, and other documents for pharmaceutical companies and Ethics boards, it is crucial to consider whether the process of pediatric consent is truly effective. Join us for an interactive round table discussion of pediatric research history, regulations, and current studies on children’s parents, and investigator’s perceptions of the consent process. A proposal for a change in the process will also be discussed.

writing? Medical writers come from diverse backgrounds.

By leveraging shared experiences, you too can overcome hesitations and recognize your unique medical writing skillset. Join us to discuss strategies for promoting individual and team success, formulating your personal value proposition, and identifying growth opportunities.

Attendee Level of Experience: All Levels of Experience Catherine Cadogan, BFA, Senior PB Clinical Writer, GE Healthcare, Waukesha, WI

S-23 • Using Project Management as the Locus of Change in Medical Writing As project issues become more complex and the desire to meet the goals and objectives of a project becomes paramount, knowing how to implement the needed processes and controls without hurting morale, stifling creativity, or alienating clients becomes key to project success. The following three topics covered in this roundtable will help you influence the outcome of a project: how to measure project status, how to communicate project status to key stakeholders, and how to implement and manage change while a project is still ongoing. These topics will be illustrated with examples taken from the clinical study report development process.

Attendee Level of Experience: Intermediate (5-10 years) Theresa M. Shalaby, MSN, RN, CCRP, Senior Regulatory Writer, Synchrogenix Information Strategies, Nashville, TN

S-21 • Trends and Transformations in CME: Interpretations and Implications for Medical Writers and Editors As the CME landscape continues to change, it is critical that professionals CME writing (eg, conducting gap analyses, writing educational grant requests, developing content for CME-certified activities, presenting educational effectiveness results) stay abreast of trends in CME. This roundtable will feature a Certified Healthcare CPD Professional and medical writers discussing educational, regulatory, and industry trends that inform how CME activities are planned, developed, implemented, and evaluated. Relative emphasis on these topics will be guided by results of a survey of medical writers. During the session, small groups will discuss the identified trends and formulate strategies to address them.

Attendee Level of Experience: All Levels of Experience Thomas Purcell, MSPM, Principal Medical Writer, PAREXEL, Saline, MI

S-24 • Advanced EndNote Tips and Tricks Join a group of advanced EndNote users to discuss tips and tricks to effectively use EndNote as a reference management software, including developing a workflow, creating working libraries, and using Cite While You Write. The session will cover library creation, quality control, retroactively adding EndNote to an already written document, and the different roles for writers and editors.

In addition, we will discuss the challenges of converting RefMan databases to EndNote.

Attendee Level of Experience: Intermediate (5-10 years) Monique Johnson, MD, CHCP, Director, Educational Development, Medical Affairs, Imedex LLC, Thomasville, NC

S-22 • Transitioning Into Medical Writing for Diverse Professionals Are you a new or transitioning professional looking to break into the field or advance your career in medical

AMWA’s 75th Annual Conference

Attendee Level of Experience: New to the Field (0-5 years) Margaret Mathes, Medical Editor, RTI Health Solutions, Research Triangle Park, NC

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saturday S-25 • 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 (tools, brainstorming approaches, technical aspects, and dissemination), 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.

script organization, management of team comments, and publication guidelines (eg, ICMJE, PRISMA).

Learning Objectives: 1. Define commonly used acronyms in publications planning. 2. Explain the function of publications committees of pharmaceutical companies. 3. List guidelines for medical publications (eg, GPP2, ICMJE).

Suggested Level of Experience: New to the Field (0-5 years) Gayle Scott PharmD, BCPS, ELS, CMPP, Principal Medical Writer, EnvisionPharmaGroup, Chesapeake, VA Kelly Kilibarda, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc., Chapel Hill, NC Chantelle Rein-Smith, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc., Chapel Hill, NC

Attendee Level of Experience: All Levels of Experience Benjamin J. Pakuts, Msc., Communications Project Specialist, University Health Network, Toronto, Ontario

OS-35 • A Primer on the Medical Device Industry for Current and Aspiring Medical Device Writers [Regulatory]

Medical device writing is a great opportunity for AMWA members. Although you may be familiar with regulatory writing for pharmaceuticals and biologics, have you ever considered writing for the medical device and diagnostics industries—or, are you already engaged in device writing and want to join an in-depth discussion specific to medical devices? Don’t miss this session! We’ll introduce you to how medical devices, combination products, and companion diagnostics are regulated, and review specific examples of device regulatory documents. We hope to inspire you to consider working in the dynamic field of medical device writing!

Learning Objectives: 1. Understand the basic regulatory structure of the medical device and diagnostics industry, especially device risk classification and approval pathways. 2. Distinguish between the requirements and trends in the medical device and diagnostics industry vs. the pharmaceutical industry, especially those related to clinical research, approval requirements, and writing skills.

S-26 • The Mountain in the Storm: Staying Calm, Composed and Professional in Stressful Work Situations Medical writing can be a stressful job. Medical writers juggle multiple projects, collaborate with different teams and meet tight deadlines. It can be challenging to stay calm and composed and behave in a professional manner in this environment. Participants of this roundtable discussion will be encouraged to share their experiences and strategies for managing their behavior in stressful work environments.

Attendee Level of Experience: All Levels of Experience Carrie-Lynn Keiski, PhD, Research Communications Officer, University Health Network, Toronto

2:00–3:30 PM OS-34 • Introduction to Publication Planning [Writing for Professional Audiences]

New to publication planning? This program is a beginner’s guide to publication planning, from deciphering acronyms (eg, CAT, HEOR, SOW) to key aspects of publication planning and preparation, including the components of publication plans, the roles of publication planning team members, and best practices for publication planning and preparation. We will also discuss considerations that guide manuscript writing, such as authorship, journal selection, time and project management, manu-

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Suggested Level of Experience: New to the Field (0-5 years) Karen Bannick, MA, RAC, Principal and Founder, Bannick Consulting LLC, Isle, MN Tim Peoples, MA, ELS, CMPP, Medical Writing Manager, Amgen Inc., Thousand Oaks, CA Felicia Cochran, PhD, CMPP™, Principle Clinical Evidence Specialist, Medtronic plc, Minneapolis, MN Cyndi Carr, PhD, Manager, Medical Writing, Ventana Medical Systems, Inc., Tucson, AZ

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OS-36 • No Weak Links: Mentoring and Coaching in Medical Writing [Professional Development] This program will discuss how mentoring can positively impact the individuals and teams that rely on medical writing support. It will detail why engagement in mentoring is critical to career growth for entry-level writers and life sciences professionals. It will also map out how to find an appropriate mentor. For more advanced writers, it will detail why (and how) they should mentor up-andcoming writers and how mentoring and coaching positively impacts teams.

Learning Objectives: 1. Explain why writers should engage in mentoring. 2. Detail how to identify and recruit a mentor. 3. Discuss how and why to be a mentor.

development of a systematic approach to analyzing and revising text. Options for arranging paragraphs and using topic sentences and transitions will be demonstrated in this review course. APPROXIMATE HOMEWORK TIME: 4 HOURS. Helen E. Hodgson, Ph.D., Westminster College, Salt Lake City, UT

WS-42 • Effectively Searching Online Databases (ES/ EW/FL) #2004 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.

Suggested Level of Experience: All Levels of Experience Robin Whitsell, BA, BPh, President, Whitsell Innovations, Inc., Chapel Hill, NC Lyn Raghai, MEd, Principal Medical Writer, Takeda Pharmaceuticals Inc., Cambridge, MA Katy Zabell, PhD, Medical Writer I, PAREXEL International, Avon, IN

2:00–5:00 PM WS-40 • Advanced Writing (ADV) #706 Experienced biomedical writers will explore ways in which they can become even better. Participants will discuss the cognitive processes used by writers and a few finer points of style, and they will learn some successful strategies for approaching (and completing) a writing project. For the precourse assignment, participants will begin to analyze the process used in their writing and the effect of writer’s block on that process. Recommended: 5 years of experience in editing or writing. APPROXIMATE HOMEWORK TIME: 2-3 HOURS.

Thomas Gegeny, MS, ELS, Stakeholder Engagement Leader, Clear Pharma, Westport, CT

Marianne Mallia, ELS, Editor, Scientific Publications, Mayo Clinic, Scottsdale, AZ

WS-43 • Essential Ethics for Medical Communicators (ES) #2006 This workshop is required for individuals working to earn the Essential Skills certificate. The workshop leader will provide a basic overview of ethical considerations with a focus on the AMWA Code of Ethics. The workshop com-

WS-41 • Effective Paragraphing (ES/G) #2003 This lecture and discussion workshop provides novices and moderately experienced writers and editors with some basic paragraphing techniques for achieving clarity, readability, and desired emphasis. The objective is

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full program schedule

prises 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.

WS-46 • Writing and Designing Materials for Patient Education (CP/EW/PRAM) #3021 Through lecture and discussion, writers with little or no experience in writing for patients will work through the what, who, and how of a patient-education piece: planning, research, writing, design, production, and evaluation. Participants will critique sample booklets and review the homework. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.

Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach VA

WS-47 • Using Classical Rhetoric Principles to Enhance Educational Materials for Lay Audiences (CP) #3025 Classical rhetorical principles and the art of persuasion are increasingly being acknowledged as integral components in medical writing. Through a blend of theory and practice, participants will learn how to identify rhetorical principles in medical writing and to apply these principles to write more effective educational materials for lay audiences. Attendees will gain a better understanding of how to use persuasive tools to meet the needs of target audiences. Hands-on exercises will help participants learn how to apply the rhetorical and persuasive techniques in specific settings and for a specific lay audiences. Some experience in writing educational materials for lay audiences is preferred. APPROXIMATE HOMEWORK TIME: 3 HOURS.

Sharon Nancekivell, Freelance, Guelph, Ontario, Canada

WS-44 • Fundamentals of Freelance Business Marketing (B) #2510 Launching and building a successful freelance business takes marketing muscle. This workshop will help those who are new to freelancing or who are thinking about launching a freelance business to strengthen that muscle, so they can get their freelance business off the ground and into the fast lane. The workshop leader will cover the whos, whats, wheres, whys, and hows of marketing a freelance business, and the exercises participants will do as homework and during the workshop will get them pumped up and ready to take on the challenge.

APPROXIMATE HOMEWORK TIME: 4 HOURS. Brian Bass, President, Bass Global, Inc., Robbinsville, NJ

WS-45 • Essentials of Copyediting (CP) #3003 Intended for beginning copyeditors, this workshop will focus on the elements and process of copyediting (not on specific language issues). Participants will learn the principles of copyediting for scientific and medical publications with the goals of accuracy, clarity, and consistency. Specific exercises will allow participants to identify typical copy problems in text and references.

Additional related topics will include the various parts of an article, editorial style, and use of style manuals.

APPROXIMATE HOMEWORK TIME: 3-4 HOURS.

Lori Alexander, MTPW, ELS, President, Editorial Rx, Inc, N. Fort Myers, FL

WS-48 • Introduction to Cancer Pharmacology (SM) #3512 This workshop is intended for beginning and moderately experienced writers and editors who have a basic understanding of cell biology, and will be taught through a combination of lecture and 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

Loretta Bohn, Senior Editor/Writer, RTI International, Research Triangle Park, NC

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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.

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: 4 HOURS. Lawrence Giraudi, Manager, Regulatory Documentation, Hoffmann-La Roche Limited, Toronto, Ontario

Sunil Patel, Sr. Drug Safety Associate, Onyx Pharmaceuticals, South San Francisco, CA

WS-51 • Serving Two Masters—Comparing and Contrasting US and EU Regulatory Processes (RR) #4024 NEW WORKSHOP! There is now an internationally agreed format for the presentation of an application dossier for a marketing authorization for a pharmaceutical product: The Common Technical Document (CTD). It is accepted by the three participating regulating authorities (USA, EU, and Japan) as well as by other “observer” parties (eg Canada). This does not mean, however that there is commonality in the processes required for submission and review, the content of dossiers, nor the way in which reviewers approach the assessment of the dossier. In particular, there are significant differences between the way data are summarized and the approach taken by European reviewers and that taken by their counterparts in the USA. While some of these differences may ultimately evolve to a state of commonality, others likely never will. Participants will be introduced to the legal origins and mandates, and will review some of the labyrinthine procedures associated with preparing, filing, and defending a licensing application. Cultural and practice differences and similarities between the EU and USA will be explored. APPROXIMATE HOMEWORK TIME: 2-3 HOURS.

WS-49 • Summarizing Clinical Safety Data for an NDA (RR) #4014 This workshop is appropriate for regulatory/medical communicators who are moderately experienced in writing clinical regulatory documents. The teaching style will be primarily lecture with an exercise and some opportunity for discussion. The workshop leader will focus on what regulatory/medical communicators need to know to effectively write the high-level clinical safety documents required specifically by the Food and Drug Administration for US New Drug Applications (NDAs), namely the Module 5.3.5.3 Report of Integrated Safety Analysis (ISS) vs the Module 2.7.4 Summary of Clinical Safety. Associated regulations and guidelines will be discussed, as well as the source documents and other tools needed for generating these documents. APPROXIMATE HOMEWORK TIME: 2-3 HOURS. Marijke H Adams, PharmD, PhD, President, MH Adams & Associates, Inc., Davie, FL

WS-50 • Clinical Study Report Writing: From Tables, Listings, and Graphs to Text (RR) #4019 This workshop is intended for writers and editors in clinical research with basic to moderate experience in developing clinical study reports (CSRs). With a focus on practical guidelines and examples, the workshop will give you a sense of how best to summarize information from statistical tables, listings, and graphs (TLGs) for a CSR. Examples will include selected passages from the

AMWA’s 75th Annual Conference

Art Gertel, Principal Consultant, MedSciCom, LLC, White House Station, NJ

3:30–4:00 PM Beverage Break in the exhibit hall

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followed publication guidelines and applicability to manuscript development. 3. Understand role of the medical writer in managing development of manuscripts.

4. Identify appropriate management of issues that may arise during manuscript development.

4:00–5:00 PM OS-37 • Introduction to Pharmacokinetics [Regulatory, Relevant Skills]

Elucidating the pharmacokinetics (PK) of a drug is a small but critical part of drug development. Why is knowledge of the PK of a drug important? How are the common PK parameters determined, and more importantly, how are they interpreted, and how is this knowledge applied? Far from being esoteric, the fundamental concepts of PK are easy to understand. Let me guide you as we follow the movement of drugs through the body and describe this movement using simple mathematical relationships. With this understanding, you will be better equipped to tackle your next PK writing assignment with confidence.

Learning Objectives: 1. Understand the four major processes involved in the movement of drugs in the body.

2. Understand how common noncompartmental PK parameters are derived and interpreted.

Suggested Level of Experience: New to the Field (0-5 years) Ann L. Davis, MPH, CMPP, Global Publication Advisor, BristolMyers Squibb, Princeton, NJ

OS-39 • How to Make Your Webinar Relevant, Impactful and Memorable [Relevant Skills, Technology/ Social Media]

As medical communicators, we can harness the value of webinars to increase our online presence and marketing efforts. Effective webinar presentation is not the same as effective public speaking. This session will discuss the main components of webinar presentation and delivery. We will discover tools that will allow you to engage your audience and explore the novel keys and technologies that will make your webinar presentation relevant, impactful and memorable.

Learning Objectives: 1. Understand the main components of webinar presentation and delivery. 2. Discover tools that will engage your audience. 3. Learn how to make your webinar relevant, impactful, and memorable.

Suggested Level of Experience: New to the Field (0-5 years) David Karhu, BSc, Senior Medical Writer, Veristat, LLC, Holliston, MA

OS-38 • Journal Manuscripts from Soup to Nuts [Professional Development, Writing for Professional Audiences]

Suggested Level of Experience: Intermediate (5-10 years) Ruwaida Vakil, MS, Principal, ProMed Write LLC, Somerset, NJ

Development of a robust, balanced manuscript with a high likelihood of acceptance is a complex process, and the writer has to take charge of this process for it to be successful. This session will provide a comprehensive list of “dos and don’ts” for manuscript development, with guidance on everything from outlines and story flow to managing relationships with authors and journal editors.

This is a step-by-step guide covering industry standards, editors’ expectations, good writing practice, project management, and potential issues that may arise during the manuscript development. We will also go over the “anatomy of a manuscript” with particular attention to objectives and content of each section.

Learning Objectives: 1. Understand appropriate construction model for manuscripts. 2. Identify commonly

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full program schedule

6:00–8:00 PM AMWA’s Diamonds and Denim 75th Anniversary Reception and Dinner (complimentary) Whether you want to dress up, or play it casual, this special occasion will recognize what we’ve accomplished in the first 75 years of growing the medical communication profession, as well as share excitement for the next 75 years to come. The reception and dinner are included in your registration fee.

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AMWA’s Certificate Program AMWA workshops allow medical communicators to increase their knowledge, refresh their skills, and investigate new areas. Credit workshops provide an interactive 3-hour learning experience with peers and AMWA’s expert workshop leaders. Depending on the content covered, workshops usually comprise 16 to 30 attendees and include real-life exercises and small-group breakouts.

As the world of medical communication changes, the association updates existing workshops and develops new ones.

Multiple designations are included in workshop listings to accommodate people enrolled in both new and old certificate programs. Credit for a workshop can be applied once, to one certificate only.

AMWA awards the appropriate certificates when the requirements have been fulfilled. Please allow AMWA HQ staff sufficient time after the conference to process workshop credits. You may review your workshop curriculum history by logging in to www.amwa.org (website) and clicking on “My Curriculum History” in the quick links under Account Management.

Enrollment is required in order to earn an AMWA certificate. The enrollment fee is a one-time fee. Only enrolled participants can receive credits toward a certificate.

Additional fees apply for workshop participation and self-study workbook purchases. You may earn an AMWA certificate by participating in 8 AMWA workshops in a content area. One of these workshops must be the ethics workshop applicable to that certificate, and for specialty certificates up to two workshops can be electives of your choice. Earning an AMWA certificate is a respected part of a career path in the field.

Enrollment is available for AMWA’s Essential Skills certificate and 3 specialty certificates (listed below).

Certificate Types Essential Skills (ES)– Take your good foundation of experience to the next level! Tailored for medical communicators, you’ll improve basic editing, writing, communication, and bibliographic skills. These truly are the essential skills that can serve as the foundation for success in the profession.

You may take credit workshops without enrolling in a certificate program, but you must be enrolled in the specific certificate program to which the workshop is applicable to receive credit toward that certificate. After enrolling in a certificate program, you have 6 years to complete the requirements to earn the certificate. Workshops may be taken in any order during that time.

Composition and Publication (CP)– Explore your “inner editor” with this specialty 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.

Concepts in Science and Medicine (SM)– Deepen your understanding of basic concepts in science and medicine with this specialty certificate. If you’re new to science or even if you have a science background, this certificate will increase your knowledge and provide a foundation for further study in areas both inside and outside your specialty.

If you are not enrolled in a certificate program but participate in a workshop and wish to receive credit for that workshop, you need to enroll in the certificate program to which the workshop is applicable within 90 days of completing the workshop. In order to obtain credit, you must have successfully completed the homework and attended the entire workshop (3 hours).

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AMWA’s Certificate Program Precourse Work (Homework)

Regulatory and Research (RR)– Regulatory writing is about more than just writing. Explore how to review research to find data patterns and communicate these findings effectively. Learn how to prepare documents compliant with guidelines and regulations through the entire spectrum of drug and/or device development.

You’ll develop specialized writing and science skills for regulatory and drug-development environments in this specialty certificate.

Each credit workshop includes homework. Typically, the purpose of the homework is to give participants needed background information for the workshop and also to help the workshop leader assess the skill levels of participants.

Once you register for the conference, you will receive an e-mailed confirmation which will include the link for downloading homework from the AMWA website. 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 the inability to complete the homework by the deadline.

Rules for Earning Workshop Credit for Certificates • Enrollment in the certificate program corresponding to the workshop designation (CP, ES, RR, or SM) is required.

• Credit for a workshop can be applied only once.

• Workshop homework must be received by the leader by the stated deadline of September 9, 2015.

If you have difficulty accessing the homework, please contact AMWA HQ 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 of September 9, 2015.

• 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.

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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.

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annual conference committee

annual Conference Committee ADMINISTRATOR Noelle Demas, MS Panorama MedWriters Group, Inc, San Diego, CA ADMINISTRATOR ELECT Yeshi Mikyas, PhD, ELS, CMPP MedImmune, Gaithersburg, MD

Tara Ann Cartwright, PhD Morrisville, NC

WORKSHOP COORDINATOR Hope J. Lafferty, AM, ELS Hope Lafferty Communications, Nashville, TN

Jennifer Houser, CCRP, RAC Seattle Genetics, Inc., Bothell, WA

Conference Program Manager (AMWA Staff Liaison) Becky Phillips

Larry Lynam The Lynam Group, Coral Springs, FL

AMWA’s 75th Annual Conference

Jenilyn Virrey, PhD, CMPP Amgen, Inc., Thousand Oaks, CA Wendy Wippel Medtronic, Inc., Memphis, TN

Adi Ferrara, MS, ELS HIV Vaccine Trials Network, Seattle, WA

Style

Rene Michelle Sauer, PhD, ELS, CRA International Medical Relief, Cypress, TX Kent Steinriede, MS Parexel International, Bala Cynwyd, PA

Christina Bennett inVentiv Medical Communications, Harlingen, TX

Celebrate in

Joanne Rosenberg, MS, ELS Jazz Pharmaceuticals, Highland Park, NJ

AMWA’s Diamonds and Denim 75th Anniversary Reception and Dinner You are cordially invited to join us as we blend our wonderful San Antonio location with the celebration of our diamond anniversary during this special event. As the theme implies, choice of attire is wide-ranging: from cowboy hats and boots to cocktail dress. Please wear what makes you most comfortable. Dinner is included with full conference registration or one-day conference registration. Single dinner tickets are also available.

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2014–2015 EXECUTIVE committee

EXECUTIVE COMMITTEE / AMWA staff PRESIDENT Karen Potvin Klein, MA, ELS Director, Grant Development and Medical Editing Biomedical Research Services and Administration, Wake Forest University Health Sciences Winston-Salem, NC PRESIDENT-ELECT Stephen N. Palmer, PhD, ELS Senior Scientific Medical Writer, Texas Heart Institute Houston, TX IMMEDIATE PAST PRESIDENT Brian Bass President, Bass Global, Inc Robbinsville, NJ

AMWA STAFF

CHAPTER RELATIONS ADMINISTRATOR Hilary Graham, MA Director, Business Development, INC Research Austin, TX EDUCATION ADMINISTRATOR Kristina Wasson-Blader, PhD, ELS Scientific Editor, University at Buffalo Buffalo, NY MEMBER RESOURCES ADMINISTRATOR Cynthia L. Kryder, MS, CCC-Sp Medical Communications Specialist Phoenixville, PA

SECRETARY Lori L. Alexander, MTPW, ELS President, Editorial Rx, Inc. N. Fort Myers, FL TREASURER Christine F. Wogan, MS, ELS Program Manager, MD Anderson Cancer Center Houston, TX 2015 ANNUAL CONFERENCE ADMINISTRATOR Noelle H. Demas, MS Independent Medical Writing Consultant and President, Panorama MedWriters Group, Inc. San Diego, CA EXECUTIVE DIRECTOR Susan Krug, CAE

PUBLICATIONS ADMINISTRATOR Deborah A. Whippen Vice-President, Editorial Rx, Inc. N. Fort Myers, FL EXECUTIVE DIRECTOR (EX OFFICIO) Susan Krug, CAE

MEMBERSHIP MANAGER AND DATABASE COORDINATOR Ann Silveira

DEPUTY DIRECTOR Shari Rager, CAE DIRECTOR OF MARKETING, COMMUNICATIONS, AND MEMBER ENGAGEMENT Kim Grimm EDUCATION AND CERTIFICATE PROGRAM MANAGER Lauren Ero, MS, MEd

MEMBERSHIP ASSOCIATE AND PUBLICATIONS MANAGER Rachel Spassiani, MA EDUCATION ASSOCIATE Andrew Buskey EDUCATION PROGRAM COORDINATOR Michelle Stephey

CONFERENCE PROGRAM MANAGER Becky Phillips

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AWARDS ADMINISTRATOR Ann M. Winter-Vann, PhD Senior Medical Writer and Consultant, Whitsell Innovations, Inc Chapel Hill, NC

PROGRAM ASSISTANT Natalie Demyan

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sponsors and exhibitors silver sponsor

Interested in exhibiting and sponsoring?

Contact AMWA!

BRonze 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 2015.

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