AMWA 2012 Conference Registration Brochure

A M W A’ s 7 2 nd A n n u a l C o n f e r e n c e

OCTO B E R 4 - 6 , 2 0 1 2 | SAC R A M ENTO , CA

Registration Brochure Updated July 2012

Register early and save www.amwa.org

AMWA

Welcome

Join us at AMWA’s 72nd Annual Conference October 4-6, 2012 Sacramento, CA 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 the keynote address, open sessions, exhibit hall and expanded networking events, including: • Wednesday evening “California Dreaming” Welcome Reception ($40 value) • Thursday Networking Luncheon ($40 value) • Thursday evening Networking Reception ($35 value) • Friday morning Networking Breakfast ($25 value) • Saturday afternoon Networking Luncheon ($40 value) This conference program is designed to provide you with information and opportunities that will help you move your career forward and help you achieve—and maintain—success in medical communication. Gain new skills and knowledge to enhance your expertise as a medical communicator or increase your current skill level.

Take advantage of the information in this 2012 Annual Conference registration brochure by carefully reviewing all of the offerings.

2012 New This Year • A self-study workshop module on Tables and Graphs will be available for sale at a discount for conference attendees. It is applicable to the Essential Skills certificate and the Core certificate (G) requirement, giving certificate enrollees a chance to earn this credit via self-study. Once this module is released, it will be possible to complete an Essential Skills certificate through the 7 selfstudy modules. The module is also an excellent reference for people who are not pursuing a certificate.

• New networking events—This year we added a free networking luncheon available to all conference attendees on Thursday, a speed networking open session on Thursday afternoon, a wine and cheese networking reception on Thursday evening, and a free luncheon on Saturday.

• All conference attendees will receive a Conference Passport at registration, which can be stamped at each exhibitor’s booth. Attendees must collect all participating booth stamps to be included in the Passport prize drawing on Friday morning, and must be present at the drawing in the Exhibit Hall to win.

➲ If you attend

only 1 conference this year, AMWA’s annual conference is your best value!

Cover photo ©Justin Smith / Wikimedia Commons

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AMWA

Contents

2012

Educational Program Information. . . . . . . . . . . . . . . . . . . . 4 Major Speakers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Schedule at a Glance. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Sponsors and Exhibitors . . . . . . . . . . . . . . . . . . . . . . . . . .8 Registration Information. . . . . . . . . . . . . . . . . . . . . . . . . . 9 Hotel and Location Information. . . . . . . . . . . . . . . . . . . . 13 Travel Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Full Program Schedule . . . . . . . . . . . . . . . . . . . . . . . . . .15 Annual Conference Committee . . . . . . . . . . . . . . . . . . . . 25 2011-2012 Executive Committee. . . . . . . . . . . . . . . . . . 26 AMWA Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26 AMWA Certificate Program Information . . . . . . . . . . . . . . 27 Program Descriptions and Presenter Information . . . . . . . 30 Roundtables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30 Open Sessions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Workshops. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Poster Presentations . . . . . . . . . . . . . . . . . . . . . . . .60

Discover Golden Opportunities!

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Educational Program Information We tailor our programming to the profession, and continually review our offerings to provide options for both new and experienced medical communicators. Our goal is to provide participants an opportunity to gain new skills and knowledge to enhance their expertise in the many facets of medical communication. Open session topics are selected each year to address the needs of the profession at that time. As the world of medical communication changes, AMWA also updates existing workshops and develops new workshops to meet current and anticipated needs.

AMWA’s 2012 Annual Conference offers 85 workshops and 41 open sessions. All open sessions are included in the registration fee.

Open sessions are 1- to 1½-hour sessions on topical issues of interest to medical communicators. Workshops are 3-hour intensive small group training programs designed to enhance the skills of medical communicators.

AMWA

2012

• Register early if you plan to enroll in credit workshops, which often fill quickly. Space is assigned on a first-come, first-served basis, and credit workshops are limited to 30 participants. Advanced workshops are limited to 16 participants. (There is no limit for noncredit workshops.)

• All conference attendees are eligible to register for workshops regardless of whether they are pursuing an AMWA certificate. Workshop fees are the same whether or not the workshop is being taken for credit. New this year, each registrant may take a maximum of 4 credit workshops per conference, including no more than 3 Advanced (ADV) workshops. There is no limit on the number of open sessions or noncredit workshops registrants can attend.

Important Information Regarding Workshop Participation

• Each credit workshop includes homework to be completed prior to the conference. Participants who intend to take workshops for credit must submit a properly completed registration on or before September 5. This deadline is to allow time for AMWA headquarters staff to send registrants their homework and time for registrants to complete the homework assignments and return them to the workshop leaders by the due date of September 13.

• Workshops can be attended for an additional fee; the specific fees are listed with each workshop description. Except for workshops designated NC (noncredit), workshops are approved for credit toward an AMWA certificate as indicated by their designations (eg, ES or CP). Earning an AMWA certificate is considered part of a career path in the field and is required by many employers. Certificate program details can be found on pages 27-29.

• So that all registrants for Advanced workshops are prepared to participate in the discussions, each registrant must complete the homework and submit it to the workshop leader by the deadline, regardless of whether the registrant is taking the workshop for credit. If a registrant’s completed homework is not received by the deadline, he or she will not be allowed to attend the workshop, and no workshop credit or refund will be given.

A schedule and educational program list can be found on pages 15-24.

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AMWA

Major Speakers

2012

Neal Baer, MD Dr Neal Baer currently serves as the executive producer of CBS-TV’s A Gifted Man and is a medical expert and senior fellow at the University of Southern California Center for Communication Leadership and Policy. Dr Baer’s career in television has garnered him 7 Emmy Award nominations, as well as a People’s Choice Award, and he has worked on multiple critically acclaimed shows, including NBC’s ER and Law & Order: SVU. Dr Baer will be our keynote speaker and recipient of AMWA’s prestigious John P. McGovern Award. Don’t miss this great opportunity to hear from a speaker whose medical communication reaches a global audience.

Mary Roach Mary Roach’s humorous examinations of science and the human experience have made her a popular author and columnist. She is the renowned author of 4 books, Stiff: The Curious Lives of Human Cadavers; Spook: Science Tackles the Afterlife; Bonk: The Curious Coupling of Science and Sex; and her latest, Packing for Mars: The Curious Science of Life in the Void.

As recipient of this year’s Walter C. Alvarez Award, Ms Roach will speak during the Alvarez Award Luncheon, and her presentation is sure to be both entertaining and educational.

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Schedule at a Glance

AMWA

2012

All events take place in the Sacramento Convention Center except if noted: Hyatt (Hyatt Regency Sacramento), Sheraton (Sheraton Grand Sacramento).

» WEDNESDAY, October 3 10:00 AM–2:00 PM

Exhibitor and Poster Set‐up, East Lobby

9:30 AM–12:30 PM

BELS Testing (Hyatt)

11:00 AM–12:30 PM

2011–2012 AMWA Executive Committee Lunch Meeting, by invitation (Hyatt)

3:00–8:00 PM

Conference Registration, AMWA Information Desk and Exhibit Hall Open, Poster Displays, East Lobby

1:00–3:30 PM

2011–2012 AMWA Board of Directors Meeting, by invitation (Hyatt)

4:00–5:30 PM

AMWA Chapter Delegates Meeting, by invitation (Hyatt)

4:15–5:00 PM

AMWA New Member Orientation

5:15–6:00 PM

AMWA Conference Coach Connection

6:00–8:00 PM

“California Dreaming” Welcome Networking Reception in the Exhibit Hall, East Lobby

» THURSDAY, October 4 7:00 AM–7:00 PM 7:30–8:45 AM

AMWA Workshop Leader Breakfast, by invitation (Hyatt)

7:30–8:45 AM

Breakfast Roundtable Topic Discussions, Sheraton Grand Ballroom (ticketed event, additional fee required)

9:15–10:30 AM 10:30–11:00 AM 11:00 AM–12:30 PM 12:45–2:00 PM

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Conference Registration, AMWA Information Desk and Exhibit Hall Open, Poster Displays, East Lobby

Opening General Session and McGovern Award Keynote Address, Ballroom Sponsored Beverage Break in the Exhibit Hall, East Lobby Open Sessions Networking Luncheon (free ticketed event, advanced registration required ) (Hyatt) New event for all attendees! Connect with a group of professionals who share your interest in a particular medical communication topic

2:15–5:15 PM

Open Sessions/Workshops

3:30–4:00 PM

Sponsored Beverage Break in the Exhibit Hall, East Lobby

4:00–5:00 PM

Speed Networking Session

5:30–7:00 PM

Wine and Cheese Networking Reception in the Exhibit Hall, East Lobby

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AMWA

Schedule at a Glance (cont.)

2012

» FRIDAY, October 5 7:00 AM–4:00 PM

Conference Registration, AMWA Information Desk and Exhibit Hall Open, Poster Displays, East Lobby

7:30–8:45 AM

Networking Breakfast in the Exhibit Hall, Passport Prize Awards Poster Presentations: Visit With the Presenters in the Exhibit Hall, East Lobby

7:30–8:45 AM

AMWA Annual Conference Committee Breakfast Meeting, by invitation

9:00 AM–12:00 PM

Open Sessions/Workshops

10:15–10:45 AM

Sponsored Beverage Break in the Exhibit Hall, East Lobby

12:00–2:30 PM

Complimentary Beverages in the Exhibit Hall, East Lobby

12:30–2:00 PM

Alvarez Luncheon (ticketed event, additional fee required ) (Sheraton)

2:15–5:15 PM

Open Sessions/Workshops

3:30–4:00 PM

Sponsored Beverage Break in the Exhibit Hall, East Lobby

4:00–6:00 PM

Exhibit Hall and Poster Break‐down

6:30–9:00 PM

AMWA Sablack Awards Dinner (ticketed event, additional fee required ) (Sheraton)

» SATURDAY, October 6 7:00 AM–4:00 PM

Conference Registration, AMWA Information Desk Open, East Lobby

7:30–8:45 AM

Breakfast Roundtable Topic Discussions, Sheraton Grand Ballroom (ticketed event, additional fee required )

7:45–8:45 AM

AMWA Certification Commission Breakfast Meeting, by invitation

9:00 AM–12:00 PM 10:15–10:45 AM 12:15–2:00 PM

Open Sessions/Workshops Sponsored Beverage Break in the Exhibit Hall, East Lobby Networking Luncheon and AMWA Annual Business Meeting with Prize Drawings, and 2013 AMWA Annual Conference Kick‐off Celebration, Ballroom (free ticketed event, advanced registration required ) New event for all attendees!

2:15–5:15 PM

Workshops

3:30–4:00 PM

Sponsored Beverage Break

2:30–3:30 PM

2012–2013 AMWA Board of Directors Meeting, by invitation (Hyatt)

4:00–5:00 PM

2012–2013 AMWA Executive Committee Meeting, by invitation (Hyatt)

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2012

EXHIBITORS

SPONSORS

Sponsors and Exhibitors

AMWA

*AMWA does not endorse any of the products or services associated with exhibitors, sponsors (other than AMWA chapters), or session speakers at its annual conference.

Conference exhibitors and sponsors do not influence the content or selection of presenters for workshops or programming at the AMWA Annual Conference.

Sponsors and Exhibitors as of July 5, 2012.

NEW EXHIBITOR AND SPONSORSHIP OPPORTUNITES

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The exhibit hall will be a hub of activity, connecting conference attendees to the resources and opportunities of interest to the medical writing community. If you have favorite vendors or suppliers, please encourage them to join us as exhibitors or sponsors in Sacramento.

Please share the new Exhibitor/Sponsor Prospectus or have interested parties contact Natalie DeSoto, advertising sales consultant, directly at natalie.desoto@theygsgroup.com.

AMWA

Registration Information

2012

2012 AMWA Annual Conference Fees AMWA Student Member

Nonmember

AMWA Member Early

Regular

On-site

Early

Regular

Onsite

Early or Regular

On-site

Full Conference

$385

$400

$435

$545

$550

$595

$150

$200

Thursday Only

$175

$200

$225

$295

$320

$320

$100

$150

Friday Only

$175

$200

$225

$295

$320

$320

$100

$150

Saturday Only

$100

$100

$125

$200

$225

$225

$50

$75

General Registration Fees:

Early Bird rates are available through August 25

Include access to the keynote address, open sessions, exhibit hall, and expanded networking events, including:

Regular registration rates: August 26 through September 15

• Wednesday evening “California Dreaming” Welcome Reception ($40 value) • Thursday Networking Luncheon ($40 value) • Thursday evening Networking Reception with cash bar ($35 value) • Friday morning Networking Breakfast ($25 value) • Saturday afternoon Networking Luncheon ($40 value)

On-site registration rates: October 3 through October 6 Student registration rates are available for AMWA student members only

Special Ticketed Events with Additional Fees

Fee per Ticket

Breakfast Roundtable, Thursday or Saturday

$24

Alvarez Luncheon, Friday

$40

Sablack Awards Dinner, Friday evening

$55

Guest Pass (non-registrant) to Wed. or Thurs. evening reception

$35

Workshop Fees

AMWA Member

Nonmember

Credit workshop

$100

$200

Advanced credit workshop

$125

$225

Noncredit workshop

$55

$100

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Registration Information

AMWA

2012

General Registration Information

Confirmation

Conference registration is an online process. Payments accepted include VISA, MasterCard, American Express, and check. If paying by check, please choose that payment option on the online form and mail in a check with a copy of your printed submission confirmation.

Registrations will not be processed without payment.

Registrations are processed in the order in which they are received.

An automatic e-mail will be sent to confirm that your registration was submitted. After your registration is processed by AMWA staff, you will receive an e-mailed receipt with instructions for downloading the homework assignments for any credit workshops you selected.

Please review your receipt carefully. If you do not receive your conference registration receipt within 10 business days, please contact AMWA at becky@amwa.org.

AMWA headquarters staff processes registrations within 7 days of receipt in the order received, whether received by mail or online. Payment must be received at the time of registration. Please note that registering online at AMWA’s website (www.amwa.org) does not guarantee seating in any workshop or activity; space is assigned on a first-come, first-served basis when AMWA staff processes the registrations. Registration confirmations are e-mailed to registrants. The URL and password for downloading homework from the Web (if applicable) are included with the receipt if the homework is available in electronic form; otherwise, a hard copy of the homework will be mailed with the confirmation.

Registration for Special/ Ticketed Events For events where reservations are required, you must reserve your space during the registration process. Where attendance is limited, reservations will be made on a first-come, first-served basis. Tickets for events you have successfully reserved will be included in the registration packet you receive when you arrive at the AMWA Annual Conference. Please note that that the Thursday and Saturday luncheons are free with registration; however, advanced registration is required so that we may plan accordingly.

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Financial Disclaimer for Credit Card Payments AMWA reserves the right to charge the correct amount if it is different from the total payment you enter during the registration process.

Guest Policy A guest at an AMWA meeting is defined as a spouse, partner, friend, adult child (21 years and older) or other family member. Guests are admitted to only evening receptions, Alvarez Luncheon on Friday, and the Sablack Awards Dinner on Friday. A medical communication colleague who will attend educational and professional programming may not register as a guest. He or she must pay the appropriate registration fee.

Guest tickets may be purchased for the Wednesday reception, the Thursday reception, the Alvarez Luncheon on Friday, and the Sablack Awards Dinner on Friday.

Guest tickets can be purchased online through the registration form or on-site at the conference.

AMWA

Registration Information

2012

Policy on Children

Substitutions

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.

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

Key Deadline Dates Early Bird rates are available through August 25 Regular registration rates: August 26 through September 15* On-site registration rates: October 3 through October 6 Last day to cancel and receive a refund: September 15 *If payment is not received prior to arriving on-site, you will be charged the on-site registration fee. Your registration is not complete until payment has been received.

Cancellation/Refunds If a conference workshop is canceled by AMWA, every effort will be made to notify registrants at least 14 days before the day of the course, and fees will be refunded.

If a registrant needs to cancel participation in the conference, a written request to cancel registration and request a refund must be submitted via e-mail to becky@amwa. org no later than September 15, 2012. Refunds will be issued via the same method of payment, less a nontransferrable $75 cancellation fee. No refunds or credits will be given for failure to attend, late arrival, unattended events, or early departure.

Registration Questions If you have any questions or problems regarding your registration, please contact Becky Phillips at becky@amwa.org or by telephone at 240-238-0940, ext 103.

Participants with Disabilities or Special Needs If you have a disability or special need that may affect your participation in the 2012 Annual Conference, please contact AMWA at becky@amwa.org before September 15, 2012, to indicate your requirements.

Consent to Use of Photographic Images Registration and attendance at, or participation in, AMWA’s Annual Conference and related events constitutes an agreement by the participant to AMWA’s use and distribution (both now and in the future) of the participant’s image or voice in photographs, videotapes, electronic reproductions, and audiotapes of the conference.

Credit workshops registrations canceled or changed prior to August 25 are subject to a $25 cancellation fee.

Fees for credit workshops are nonrefundable after August 25, 2012.

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Registration Information Registration and AMWA Information Desk Area On-site Registration packets for people who have registered in advance will be available in the registration area beginning at 3:00 PM Wednesday, October 3, in the East Lobby of the Sacramento Convention Center. The packet will contain the registrant’s identification badge with tickets (if applicable) and on-site program. On-site registration will also be available at the same location. Exhibits, message board, job exchange board, and poster displays will be located in the same area as conference registration.

Submissions for the 2012 AMWA book awards and the 2012 winning books will be on display.

If you are a new member or this is your first annual conference and you would like to connect with experienced AMWA members and other first-time attendees at the conference, plan to attend the New Member Orientation on Wednesday from 4:15 to 5:00 PM and/or the Conference Coach Connection on Wednesday evening from 5:15 to 6:00 PM, immediately before the “California Dreaming” Welcome Networking Reception. These events are designed to provide an opportunity to meet and network with other attendees in a casual setting.

ADD TO YOUR EXPERIENCE—AND YOUR PORTFOLIO Make the most of the 2012 AMWA Annual Conference by covering a session or speaker for the AMWA Journal. The experience will not only give you a published piece to add to your portfolio but will also help bring the conference to hundreds of AMWA members who are unable to attend. If it will be your first conference, write about the experience to help promote the value of the conference to others who have not attended yet. If you are interested in either opportunity, send an e-mail to the AMWA Journal editor at amwajournaleditor@editorialrx.com.

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New Members/First Timers

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

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AMWA

Hotel and Location Information

AMWA

2012

The conference will be taking place at the Sacramento Convention Center, the Hyatt Regency Sacramento, and the Sheraton Grand Sacramento. AMWA has hotel sleeping room blocks at the Hyatt and the Sheraton.

To make your hotel reservation, please use the links provided below or call the toll-free numbers. Be sure to reference the AMWA Conference to receive the special group rate. We expect the room blocks to fill up, so be sure to make your reservation early!

AMWA Conference Hotel Room Rates (plus 12% tax and $1.65 per night tourism fee) Single/Double Occupancy: $159 Triple Occupancy: $184 Quad Occupancy: $209 To secure these rates, reservations must be made prior to August 31, 2012, subject to availability.

Reservations made after August 31 may be at the hotel’s prevailing rate.

Sheraton Grand Sacramento 1230 J Street Sacramento, CA 95814 https://www.starwoodmeeting.com/Book/AMWA2012 Reservation line: 1-800-325-3535, refer to AMWA Conference Hyatt Regency Sacramento 1209 L Street Sacramento, CA 95814 https://resweb.passkey.com/go/2012AmMedWriters Reservation line: 1-888-421-1442, refer to AMWA Conference

Sacramento Convention Center.

Photo courtesy of Sacramento Convention & Visitors Bureau.

Please note that our contracts for the best possible room rates each year require AMWA to guarantee a predetermined number of sleeping rooms. If the association does not meet the contracted room block, the hotel can charge an attrition fee, which could result in higher registration fees at future conferences. Therefore, we encourage you to book your room through our block at the conference hotel by using either the Web links or toll-free numbers above and identify yourself as an AMWA attendee.

Note: AMWA does not arrange hotel reservations or roommate pairing. However, if you are interested in sharing a room, you may post that information on the Bulletin Board on AMWA’s website.

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Travel Information The travel experts at Lonely Planet recently named the California Gold Country as a “Top 10 US Travel Destination for 2012.” The list features destinations that are “new, interesting, and in some cases likely to be overlooked by travelers.”

The City of Sacramento is located in Northern California—90 minutes northeast of San Francisco.

Small-town friendly with big-city amenities and with a population of 1.5 million in the metropolitan area, Sacramento is one of the West’s fastest-growing, most affordable, and most attractive cities. California’s capital city hosts more than 6 million visitors each year.

Its mild climate is an ideal backdrop for enjoying the city’s many attractions, including world-class shopping, restaurants, golf courses, historic Old Sacramento, and the Sacramento Zoo. With more than 40 art galleries and dozens of museums, Sacramento is rich with culture and is home to the worldrenowned Crocker Art Museum. Whatever your interests, the options and attractions are endless.

The Sacramento International Airport (SMF), situated 12 miles northwest of Sacramento, is just a 15-minute freeway drive from the Sacramento Convention Center Complex. Service is available from 14 major carriers and one commuter airline. Open 24 hours a day, 365 days a year, SMF has recently added 7 new air carriers (Aloha, Mexicana, Frontier, Hawaiian, Jet Blue, ExpressJet, and Air Canada) to its roster.

The Amtrak (former Southern Pacific) station is currently used for the San Jose-Oakland-Sacramento Capitol Corridor trains. Located approximately a mile northwest of the Convention Center Complex, the depot is a convenient first or last stop in your visit to Sacramento when traveling the rails.

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2012

Old Sacramento (top), Crocker Art Museum (middle), and Delta King with Pyramid (bottom). Photos courtesy of Sacramento Convention & Visitors Bureau.

Full Program Schedule-Wednesday All events take place at the Sacramento Convention Center except if noted: Hyatt (Hyatt Regency Sacramento), Sheraton (Sheraton Grand Sacramento)

» WEDNESDAY, October 3 9:30 AM–12:30 PM BELS TESTING (Hyatt) (Registration is available through the Board of Editors in the Life Sciences, www.bels.org.)

3:00–8:00 PM CONFERENCE REGISTRATION, AMWA INFORMATION DESK AND EXHIBIT HALL OPEN, POSTER DISPLAYS (East Lobby)

1:00–3:30 PM 2011-2012 BOARD OF DIRECTORS MEETING (Hyatt) Presiding: Barbara R. Snyder, MA, 2011-2012 AMWA President

4:00–5:30 PM CHAPTER DELEGATES SESSION Presiding: Katharyn Spiegel, PhD, 2011-2012 Administrator, Department of Chapters/Membership Members who have been appointed by their chapters as delegates to the Board of Directors are invited to attend.

This session provides delegates an opportunity to discuss chapter issues that may have arisen since the spring board meeting.

4:15–5:00 PM NEW MEMBER ORIENTATION This session provides an opportunity for new members of AMWA to meet the association leadership, to ask questions about how AMWA works, and to learn more about the benefits of belonging to an association of medical communicators.

5:15–6:00 PM CONFERENCE COACH CONNECTION Attending the annual conference for the first time can be somewhat daunting. If this is your first annual conference

AMWA

2012

KEY TO WORKSHOPS PLEASE NOTE: Permanent workshop numbers follow the titles of each credit workshop. Certificate program enrollees should search their individual AMWA records to determine whether they have already taken specific workshops.

Abbreviations NC Noncredit workshop OS Open session WS Workshop Workshop Designations Workshop designations are the initials in parentheses directly following the workshop titles. They indicate the certificate program(s) to which the workshop is applicable. Most workshops are listed with multiple designations to accommodate both new and old certificate programs.

For Essential Skills certificate enrollees: ES Essential Skills certificate workshop For people enrolled in one of the specialty certificate programs: B Business certificate workshop CP Composition and Publication certificate workshop RR Regulatory and Research certificate workshop SM Concepts in Science and Medicine certificate workshop For people enrolled in the Core certificate program before January 31, 2010, and working on one of the Core certificates: G General Core certificate workshop ED Educators Core certificate workshop EW Editing/Writing Core certificate workshop FL Freelance Core certificate workshop PH Pharmaceutical Core certificate workshop PRAM Public Relations/Advertising/Marketing Core

certificate workshop For people enrolled in the Science Fundamentals certificate program before January 31, 2010, and working on that certificate: SG Science workshop—General SBS Science workshop—Body Systems SDS Science workshop—Disease States SDT Science workshop—Diagnostics and Therapeutics For people enrolled in the Advanced Certificate program before January 31, 2010, and working on that certificate: ADV Advanced certificate workshop

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Full Program Schedule-Thursday

AMWA

2012

and you would like to connect with experienced AMWA members and other first-time attendees at the conference, plan to attend the Conference Coach Connection on Wednesday evening immediately before the “California Dreaming” Welcome Networking Reception. It is designed to provide an opportunity to meet other attendees in a casual setting and to obtain answers to your questions about AMWA and the annual conference. Coaches will be designated by a gold heart on their conference badges, and first-time attendees will be designated by a red dot on their badges.

T-01 What Doctors Really Want to Know: Increasing the Likelihood of Publication in a Clinical Journal

6:00–8:00 PM

T-06 Benefits and Roles of Having an Editor on the Writing Team

“CALIFORNIA DREAMING” WELCOME NETWORKING RECEPTION IN THE EXHIBIT HALL SPONSORED BY RPS INC (East Lobby) The Welcome Reception is an opportunity for all attendees to meet in a fun and informal setting with hors d’oeuvres and beverages. Exhibits will also be open at this time.

» THURSDAY, October 4 7:00 AM–7:00 PM CONFERENCE REGISTRATION, AMWA INFORMATION DESK AND EXHIBIT HALL OPEN, POSTER DISPLAYS (East Lobby)

7:30–8:45 AM BREAKFAST ROUNDTABLE TOPIC DISCUSSIONS (Sheraton Grand Ballroom) Lori De Milto, MJ, Coordinator Writer for Rent, LLC, Sicklerville, NJ At these informal breakfast sessions, medical communicators can exchange ideas, experiences, and insights about topics affecting their professional lives. A knowledgeable leader will guide the discussion at each table, which is limited to 9 registrants. Leader information and discussion points are available in the expanded description document, available at www.amwa.org.

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T-02 Establishing a Web Presence with Your Own Domain Name and Website T-03 Making the Most of Microsoft Word 2010 T-04 What Really Is Networking? How Can Seasoned Medical Writers Benefit from It? T-05 Onboarding Medical Writers–Helping New Writers to Quickly Become Productive, Efficient, and Credible Leaders of the Writing Team

T-07 Tools and Strategies for Enhanced Productivity T-08 How to Rock Conference Coverage (While Maintaining Sanity) T-09 Tips for Conducting an Effective and Focused Document Review Meeting T-10 Fostering Successful Partnerships Between Editors and Authors at Academic Medical Centers T-11 Writing the Meaningful Informed Consent for the Research Participant T-12 Social Media in Pharmaceutical Medical Communication: Myth and Reality T-13 Advanced Marketing: Using A Database and Virtual Assistant to Boost Your Business T-14 Evaluating Roles and Responsibilities for Medical Writers: Employer and Employee Perspectives T-15 Certification of Editors in the Life Sciences T-16 Going All Digital With Your Reference Binder T-17 Freelance Writing for the Medical Device Industry T-18 Freelancing Lessons Learned T-19 How to Write a Book Proposal (for a HealthRelated Book) T-20 Writing Science for Children and Young Adults

Full Program Schedule-Thursday

AMWA

2012

CANCELED T-21 Remote Team Leadership: Connecting the Dots

9:15–10:30 AM

T-22 How to Succeed in Freelance Medical Writing Without a Scientific Background

OPENING GENERAL SESSION AND MCGOVERN AWARD KEYNOTE ADDRESS (Ballroom) Welcome: Barbara R. Snyder, MA, 2011-2012 AMWA President Introduction of the McGovern Award Recipient: The John P. McGovern Medal is given to a person known for preeminent contributions to medical communication.

Dr Neal Baer is the keynote speaker and recipient of AMWA’s prestigious John P. McGovern Award. Dr Baer currently serves as the Executive Producer of CBSTV’s A Gifted Man and is a medical expert and senior fellow at the University of Southern California Center for Communication Leadership and Policy. Dr Baer’s career in television has garnered him 7 Emmy Award nominations, as well as a People’s Choice Award, and he has worked on multiple critically acclaimed shows, including NBC’s ER and Law & Order: SVU.

T-23 Instituting Necessary Measures for a New Organization T-24 Applying Plain Language Principles in Patient Education Materials T-25 Checking it Twice…Gonna Make Sure QA’s Not Naughty But Nice T-26 Medical Marketing the Science Behind the Story T-27 Internal Marketing: How Newer Freelancers Can Keep Clients Coming Back T-28 Publishing a Physician-Targeted Newsletter T-29 ClinicalTrials.gov Posting for Beginners T-30 Ins and Outs of Working With Japanese Authors T-31 Be All That You Can: Professional Certifications, Educational Opportunities, and Programs of Interest to Biomedical Communicators T-32 Quality Control Feedback on Documents for Submission T-33 Electronic Archiving for the Home Office T-34 Effective Communication Between Medical Writer and the Scientific/Technical Mindset T-35 Anatomy of a Newsletter: Design, Content and Delivery to a Health Care and Research Audience

10:30–11:00 AM SPONSORED BEVERAGE BREAK in the Exhibit Hall (East Lobby)

11:00 AM–12:30 PM OPEN SESSIONS OS-01 So You Want to Write a Book?

OS-02 Words, Words, Words: Yours, Mine, or Someone Else’s?

OS-03 If Looks Could Kill…Your Career

T-36 Contract Research Organization Writing Opportunities: It’s More Than Just Regulatory

OS-04 FDA Drug Safety Communications: Principles, Practice, and Evaluation

T-37 Grantsmanship 101: Tips for Writing and Editing an NIH Grant

12:45–2:00 PM

T-38 Writing for the Medical Device Industry: The Example of the Cardiac Device Market T-39 Benefits of Publication Standard Operating Procedures T-40 Working for the Diagnostics and Biotechnology Industries: Which One is the Right Fit for You?

NETWORKING LUNCHEON (free ticketed event, advanced registration required ) (Hyatt Regency Ballroom) Feed your body and mind. Come grab lunch and connect with a group of professionals who share your interest in a particular medical communications topic. Freelancing.

Consumer health writing. Career development (professional credentials, affiliations, and certifications).

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Full Program Schedule-Thursday

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2012

Publications planning. Working with recruiters. Proposal writing (business and grant). Challenges for editors.

Public policy and health care compliance. Or roam freely from group to group, and satisfy all your interests.

WS-11 Reporting Correlation and Regression Analyses (RR/G/SG) #4011

2:15–3:45 PM

WS-13 Introduction to the Cardiovascular System (SM/ SBS) #3515

OPEN SESSIONS OS-05 Perspectives on the Challenges and Promise of Personalized Medicine OS-06 Getting to the Next Level: Using Subcontracting and Mentoring to Create Your Team and Increase Your Revenue OS-07 Beyond Belly Aches: Identifying and Differentiating Food Allergies and Intolerances

WS-12 Interventional and Observational Research Design (RR/EW/PH/SG) #4007

WS-14 Basics of Human Anatomy and Physiology (SM/ EW/PH/SG) #3503 WS-15 Usage: Choosing the Right Word for the Job (NC) WS-16 What’s in that Pill? Testing, Standards, Safety and the US Pharmacopeia (NC)

3:30–4:00 PM

OS-08 FDA Dos and Don’ts of Advertising and Promotion

SPONSORED BEVERAGE BREAK in the Exhibit Hall (East Lobby)

2:15–5:15 PM

4:00–5:00 PM

WORKSHOPS WS-01 Synergy of Style, Substance, and Audience (ADV) #711

OPEN SESSIONS OS-09 Speed Networking OS-10 The FDA as an Audience

WS-02 Advanced Writing (ADV) #706

4:00–5:30 PM

WS-03 Outlining for Writers and Editors (ES/EW/FL) #2007 [same as WS 20]

OPEN SESSIONS OS-11 How Well Do You Know HIPAA? What the Law Requires of Medical Communicators

WS-04 Effectively Searching Online Databases (ES/EW/ FL) #2004 WS-05 Business Ethics for Medical Communicators (B) #2511

OS-12 Accountable Care Organizations: Changing Health care Delivery and Providing New Medical Writing Opportunities

WS-06 Journal Submissions Other Than Research Articles (CP/EW) #3007

OS-13 How To Get Your Second Medical Writing Job

WS-07 Writing and Editing NIH Grants (CP/EW/FL) #3022

WINE AND CHEESE NETWORKING RECEPTION in the Exhibit Hall (East Lobby) Few pairings in the culinary world are more revered than wine and cheese. Join fellow attendees in enjoying local artisanal cheeses and other sumptuous hors d’oeuvres.

Receive a ticket for a complimentary beverage, and cash bar is available.

WS-08 Making Effective Slides (CP/EW) #3008 WS-09 Developing Publications in Accordance with GPP2 Guidelines (CP) #3026 WS-10 Regulatory Aspects of the Drug Development Process (RR/PH) #4010

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5:30–7:00 PM

AMWA

Full Program Schedule-Friday » FRIDAY, October 5 7:00 AM–4:00 PM CONFERENCE REGISTRATION, AMWA INFORMATION DESK AND EXHIBIT HALL OPEN, POSTER DISPLAYS (East Lobby)

7:15–8:45 AM NETWORKING BREAKFAST WITH THE EXHIBITORS (East Lobby) A good breakfast paves the way for an engaged mind!

Enjoy a complimentary continental breakfast with the conference exhibitors.

7:15–8:45 AM POSTER PRESENTATIONS: VISIT WITH THE PRESENTERS See listings on page 60. (East Lobby)

8:30–8:45 AM PASSPORT PRIZE AWARDS (East Lobby) *New this year! All conference attendees will receive a Conference Passport at registration. Attendees can then receive a stamp on their Conference Passport as they visit each exhibitor’s booth. Attendees must collect all participating booth stamps to be included for the Passport prize drawing on Friday morning and must be present in the exhibit hall to win.

9:00 AM–12:00 PM OPEN SESSIONS/WORKSHOPS

9:00–10:00 AM OPEN SESSION OS-14 Health Care Reform for Dummies

9:00–10:30 AM OPEN SESSIONS OS-15 Evidence-Based Medical Writing: Shaping Your Readers’ Experience OS-16 After the Gold Rush: NLM and Gold Nuggets of Information!

2012

OS-18 Negotiation for Medical Writers: The Mutual Gains Approach

9:00 AM–12:00 PM WORKSHOPS WS-17 Risks and RatiosCANCELED (ADV) #721 WS-18 Computer Searching the Medical Literature (ADV) #707 WS-19 Critical Appraisal for Writers and Editors of Biomed Research Articles (ADV) #726 WS-20 Outlining for Writers and Editors (ES/EW/FL) #2007 [same as WS 3] WS-21 Elements of Medical Terminology (ES/G/SG) #2005 WS-22 Essential Ethics for Medical Communicators (ES) #2006 [same as WS 77] WS-23 Fundamentals of Freelance Business Marketing (B) #2510 WS-24 Writing Abstracts (CP/EW/PH) #3019 WS-25 Plain Language (CP/EW) #3011 WS-26 Summarizing Clinical Efficacy Data for an NDA (RR) #4013 WS-27 Writing a Protocol in Compliance with ICH Guidelines (RR) #4018 WS-28 Writing an Investigator Brochure (RR/PH) #4015 CANCELED WS-29 Communicating Results of Routine Clinical Laboratory Tests (SM/EW/PH/SDT) #3506 WS-30 Introduction to Basic Virology (SM) #3510 WS-31 Basic Immunology (SM/SBS) #3501 WS-32 Medical Writing for Instructionally Sound, Engaging e-Learning (NC) WS-33 Using Design to Improve the Readability of Medical Documents (NC) WS-34 Navigating Public Health Information Online (NC)

OS-17 How to Talk to Your IT Department R EG I S TR ATI O N B R O C H U R E

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Full Program Schedule-Friday 10:15–10:45 AM SPONSORED BEVERAGE BREAK in the Exhibit Hall (East Lobby)

10:45–11:45 AM OPEN SESSIONS OS-19 Leading a Protocol Development Project

2:15–3:45 PM OPEN SESSIONS OS-26 Scope of Medical Communications OS-27 The 90-Minute MBA for Freelances OS-28 Genetic Testing: Today and Tomorrow

10:45 AM–12:15 PM

2:15–5:15 PM

OS-22 Expanding the Continuum of Care: the Role of Medical Devices in Chronic Disease Management OS-23 Professional Medical Communicators Beware: The Challenges and Pitfalls of Publication Planning in 2012

2012

OS-25 How to Benchmark Medical Writing: Is Faster, Cheaper, Better?

OS-20 Cause of Death: PowerPoint OPEN SESSIONS OS-21 Dial 911: Emergencies in Medical Writing

AMWA

WORKSHOPS WS-35 Strategies for Improving Document Quality for Pharmaceutical Communications Managers (ADV) #722 WS-36 Understanding andCANCELED Reporting the Performance Characteristics of Diagnostic Tests (ADV) #725 WS-37 Basic Grammar I (ES/G) #2000 [same as WS 55]

12:00–2:30 PM

WS-38 Sentence Structure and Patterns (ES/G) #2009 [same as WS 57]

COMPLIMENTARY BEVERAGES in the Exhibit Hall (East Lobby)

WS-39 Punctuation for Clarity and Style (ES/G) #2008 [same as WS 79]

12:30–2:00 PM

WS-40 Tables and Graphs (ES/G) #2011 [same as WS 76]

ALVAREZ LUNCHEON (ticketed event, additional fee required) (Sheraton Grand Ballroom) Host: Brian Bass, Administrator, 2012 Annual Conference Introduction of the Alvarez Award Recipient: The Walter C. Alvarez Award is given annually to a person known for excellence in communicating health care developments and concepts to the public. Mary Roach’s humorous examinations of science and the human experience have made her a popular author and columnist.

2:15–5:15 PM

WS-41 Creative Process in Pharma Advertising and Promotion (B/PH/PRAM) #2501 WS-42 Making Effective Presentations (B/PRAM/ED) #2505 WS-43 Organizing the Medical Paper (CP/EW/FL) #3010 WS-44 Preparing CME Materials: Concepts, Strategies, and Ethical Issues (CP/EW/FL) #3012

OPEN SESSIONS/WORKSHOPS

WS-45 Using Classical Rhetoric Principles to Enhance Medical Writing (CP) #3025

2:15–3:15 PM

WS-46 Writing for Video (CP/EW/PRAM) #3023

OPEN SESSIONS OS-24 Document Quality Control: A QCer’s View of the World

WS-47 Assessing and Communicating the Benefits and Risks of Medicines (RR)

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Full Program Schedule-Friday WS-48 Investigational New Drug Applications (RR/PH) #4008 WS-49 Basics of Molecular Biology (SM/EW/PH/SG) #3504 WS-50 Evidence-Based Medicine for Medical Communicators (SM) #3509 WS-51 Approach to Writing Effective Standard Operating Procedures (NC) WS-52 Writing Clinical Evaluation Reports for Medical Devices (NC) WS-53 Cyber Security for the Medical Writer—Is Your Head in the Cloud? (NC)

3:30–4:00 PM Sponsored Beverage Break in the Exhibit Hall (East Lobby)

4:00–5:00 PM OPEN SESSIONS OS-29 Sweats versus Suits: Is Telecommuting Right for You? OS-30 Soft Skills: As Important as Technical Skills OS-31 What Is Health Economics and Outcomes Research? A Primer for Medical Writers

4:00–5:30 PM OPEN SESSIONS OS-32 Writing, the Cherokee Syllabary, and the Nature of Language OS-33 Falsifications and Retractions

4:00–6:00 PM EXHIBIT HALL AND POSTER BREAK‐DOWN

7:00–9:00 PM (6:30 PM Cocktails and Red Carpet) AMWA SABLACK AWARDS DINNER (ticketed event, additional fee required ) (Sheraton Grand Ballroom) This is the premier event at every AMWA conference, attended by the who’s who of conference attendees and

AMWA

2012

AMWA members. Named after AMWA’s first executive director, Lillian Sablack, the dinner recognizes outstanding service and contributions by medical communicators.

The evening will include an entertaining presentation by the 2012 recipient of the Swanberg Distinguished Service Award, Susan Aiello, DVM. Presentation of the President’s Award: 2011-2012 AMWA President Barbara R. Snyder, MA, will present the award.

The President’s Award is given to a person who has been a member of AMWA for at least 10 years; has made distinctive contributions to the association at the chapter level, the national level, or both; and has not served on the executive committee.

Presentation of the Golden Apple Award: Sharon L. Nancekivell, MA, chair of the 2012 Golden Apple Award Committee, will present this award for excellence in workshop leadership to Peggy Boe, RN. 2012 Student Scholarships: Qing Zhou, PhD, chair of the 2012 Student Scholarship Committee, will announce the winners of the 2012 AMWA Annual Conference Student Scholarship.

Presentation of the Eric W. Martin Awards: 2011-2012 Awards Administrator, Stephen Palmer, PhD, ELS, will present the Eric W. Martin Awards for Excellence in Medical Writing. These awards are given annually to AMWA members for articles published during the preceding calendar year.

Presentation of the AMWA Medical Book Awards: awards for excellence in the following categories: books for physicians, books for health care professionals–nonphysicians, and books for the public or health care consumers.

Presentation of 2012 Fellowships: 2012 Fellowship Awards Committee chair, Thomas P. Gegeny, MS, ELS, will present Fellowship Awards to Tamara Ball, MD; Faith Reidenbach, ELS; and Christine Wogan, MS, for significant contributions to the goals and activities of the association.

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Full Program Schedule-Saturday Presentation of the Swanberg Distinguished Service Award and Swanberg Presentation: Jane Krauhs, 2012 Swanberg Committee chair, will present the Swanberg Distinguished Service Award to Susan Aiello, DVM, for distinguished contributions to medical communication and the medical profession.

» SATURDAY, October 6 7:00 AM–4:00 PM CONFERENCE REGISTRATION AND AMWA INFORMATION DESK OPEN (East Lobby)

7:30–8:45 AM BREAKFAST ROUNDTABLE TOPIC DISCUSSIONS (ticketed event, additional fee required) (Sheraton Grand Ballroom) Michelle Zakson, MS, Coordinator Amgen Inc, Thousand Oaks, CA At these informal breakfast sessions, medical communicators can exchange ideas, experiences, and insights about topics affecting their professional lives. A knowledgeable leader will guide the discussion at each table, which is limited to 9 registrants. Leader information and discussion points are available in the expanded description document, available at www.amwa.org.

S-01 Effective Presentation Skills: From Audience Analysis Through Delivery S-02 FDA GMP Basics—In Medical Writing and Manufacturing S-03 Where Do Drug Names Come From?

S-10 Opportunities for Nurse Writers S-11 Medical Journalism Do’s & Don’ts: Tips for Successful Writing and Reporting S-12 Time Essentials. How to Use Technology and Other Tools to Work Faster and Better S-13 Covering a Congress for Your Pharmaceutical Company S-14 Creating Quality Clinical Summaries When Timelines are Tight S-15 Making Every Word Count: Creating a Novel Online Medical Information Source S-16 Introduction to Narrative Medicine S-17 Distance Education: Tips for Training Medical Writers from Afar S-18 Understanding the Challenges of Global Medicines Development S-19 How to Write an Adverse Event Narrative for a Clinical Study Report S-20 Document Infrastructure: What it is and How to Create One S-21 Pitfalls in Preparing Informed Consent Forms S-22 Transition From Benchtop to Medical Writing: Rethinking Your Experience S-23 Social Media in Pharmaceutical Medical Communication: Myth and Reality

S-05 Using Public Relations to Promote Medical Discoveries, Programs and Services

S-24 Designing a Healthy, Comfortable Office

S-07 Making the Most of Your LinkedIn Profile S-08 The Nonclinical Regulatory Package: What is It, How Does It Fit In, Where is It Necessary, and Who are the Key Contributors and Partners?

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S-09 Medical Editing: From Copy Editing to Developmental Editing

S-04 Managing Medical Writers Remotely

S-06 Going Public: Setting Up an Internet Presence for Your Freelance Business

AMWA

S-25 So, You Want to Take the BELS Exam?

S-26 Creating Powerful Printed Reports (Newsletters, Annual Reports and More): From Concept through Production S-27 AMWA for Scientists and Clinicians

Full Program Schedule-Saturday S-28 How to Advance Your Medical Writer Career Through Blogging S-29 Continuous Improvement and Flexibility: Key Skills for Success in Today’s Job Market S-30 Using Checklists for More Efficient Editing S-31 Publication Planning in 2012 S-32 Do You Have the Skills for Regulatory Writing?

S-33 Multi-Investigator Grants: Multiple Migraines or Single, Manageable Headache?

S-34 Biomarkers and Personalized Medicine 101 S-35 Getting a Handle on Version Control S-36 Highlights and Update on the Uniform Requirements for Manuscripts Submitted to Biomedical Journals S-37 Opportunities for Medical Writers in Study Data Review S-38 The Scientific Method–A Tool to Help Medical Writers be Flexible in Terms of Therapeutic Areas and Audience S-39 Avoiding Plagiarism

7:45–8:45 AM AMWA CERTIFICATION COMMISSION BREAKFAST MEETING, by invitation Presiding: Thomas P. Gegeny, MS, ELS, Commission Chair

9:00–10:30 AM OPEN SESSIONS OS-34 Translating New Media Theories into Practical Advice OS-35 Current Ethical Issues from Three Perspectives: Pharmaceutical Director, Publisher, Freelance Writer

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2012

9:15–10:15 AM OPEN SESSION OS-38 Medical Writing Certification: Where Are We Now?

9:00 AM–12:00 PM WORKSHOPS WS-54 Taxonomic Analysis of Medical Writing (ADV) #732 WS-55 Basic Grammar I (ES/G) #2000 [same as WS 37] CANCELED WS-56 Statistics for Medical Writers and Editors (ES/G/SG) WS-57 Sentence Structure and Patterns (ES/G) #2009 [same as WS 38] WS-58 Basic Grammar II and Usage (ES/G) #2001 WS-59 Coaching Skills for Leaders (B) #2512 WS-60 Introduction to the Medical Device Industry (B/ PH) #2503 WS-61 Ethical Standards in Medical Publication (CP/ EW/PH) #3004 WS-62 Essentials of Copyediting (CP/EW) #3003 WS-63 Writing and Designing Materials for Patient Education (CP/EW/PRAM) #3021 WS-64 Electronic Common Technical Document (RR/ PHP #4004 WS-65 Fundamentals of Ethics and Practical Applications (RR) #4020 WS-66 Basics of Epidemiology (RR/EW/PH/SG) #4001 WS-67 Drug Interactions (SM/EW/PH/SDT) #3508 WS-68 Introduction to Cancer Pharmacology (SM) #2512 WS-69 Ethics in Communicating Science and Medicine (SM) #3524

OS-36 eSubmissions: A Brave New World for the Medical Writer

WS-70 Writing a Meaningful Informed Consent Document in Compliance with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) Guidelines (NC)

OS-37 Strategies for Working Successfully With ESL Authors

WS-71 The Good Page: Basic Design and Typography for Writers and Editors (NC)

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Full Program Schedule-Saturday 10:15–10:45 AM SPONSORED BEVERAGE BREAK

10:45–11:45 AM OPEN SESSIONS OS-39 Planning for Future Scenarios in Medical Product Development OS-40 It’s Not Magic: It’s My Profession

10:45 AM–12:15 PM

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2012

WS-77 Essential Ethics for Medical Communicators (ES) #2006 [same as WS 22] WS-78 Bibliographic Resources for Medical Communicators (EW/G) #2002 WS-79 Punctuation for Clarity and Style (ES/G) #2008 [same as WS 39] WS-80 Medical Journalism: From Choosing a Topic through Polishing the Piece (CP/EW/FL) #3009

OPEN SESSION OS-41 Claims Crafting for the Dietary Supplement Industry: Do’s & Don’ts

WS-81 Proofreading (CP/EW) #3013

12:15–2:00 PM

WS-83 Writing the Final Report of a Clinical Trial (RR/ PH) #4016

NETWORKING LUNCHEON and AMWA Annual Business Meeting with Prize Drawings and 2013 AMWA Annual Conference Kick‐off Celebration (free ticketed event, advanced registration required). New event for all attendees! Join us to get an update on AMWA from 2011-2012 President Barbara R. Snyder, MA, and witness the passing of the gavel to the 2012-2013 President, Douglas Haneline, PhD. We will also celebrate the site of AMWA’s 2013 Annual Conference: Columbus, OH. With complimentary lunch, fabulous prizes (including a free registration to the 2013 conference), and other surprises, this is sure to be a memorable event you do not want to miss!

2:15–5:15 PM WORKSHOPS WS-72 Macroediting (ADV) #713 WS-73 Current Trends in Drug Regulations (ADV) #728

WS-82 Ethics of Communicating Regulated Drug Development Activities (RR) #4006

WS-84 Clinical Study Report Writing: From Tables, Listings, and Graphs to Text (RR) #4019 WS-85 Introduction to Cancer Biology (SM/SG) #3511 WS-86 Pharmacokinetics in Clinical Practice (SM/EW/ PH/SDT) #3519 WS-87 From Bench Scientist to Medical Writer (NC) WS-88 Write to Learn: Practical Strategies for Developing Continuing Education Content (NC) WS-89 Introduction to Pharmacoeconomics (NC)

2:30–3:30 PM 2012-2013 BOARD OF DIRECTORS MEETING, by invitation (Hyatt) Presiding: Douglas Haneline, PhD, 2012-2013 AMWA President

WS-74 Effective Paragraphing (ES/G) #2003 [same as WS 75]

3:30–4:00 PM

WS-75 Effective Paragraphing (ES/G) #2003 [same as WS 74]

4:00–5:00 PM

WS-76 Tables and Graphs (ES/G) #2011 [same as WS 40]

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SPONSORED BEVERAGE BREAK 2012-2013 EXECUTIVE COMMITTEE MEETING, by invitation (Hyatt) Presiding: Douglas Haneline, PhD, 2012-2013 AMWA President

Annual Conference Committee 2012 CONFERENCE ADMINISTRATOR AND ALVAREZ AWARD CHAIR Brian Bass Bass Advertising & Marketing, Inc., Robbinsville, NJ ANNUAL CONFERENCE WORKSHOP COORDINATOR Jennifer Grodberg, PhD, RAC Trius Therapeutics, Carlsbad, CA

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POSTER PRESENTATIONS COORDINATOR Nick Sidorovich, MSEd Rolling Hill Media LLC, Chatham, NJ Local host committee chair Nancy Katz, PhD Illyria Consulting Group, Inc., Berkeley, CA

SPECIAL INTEREST SESSIONS COORDINATOR Elizabeth G. Frick, PhD, ELS The Text Doctor, Boulder, CO GENERAL INTEREST SESSIONS COORDINATOR Noelle H. Demas, MS Independent Medical Writing Consultant, San Diego, CA SHORT SESSIONS COORDINATOR Yeshi Mikyas, PhD, ELS Amgen Inc, Thousand Oaks, CA

Please join us for the

AMWA Sablack Awards Dinner As we celebrate Hollywood Style!

Friday, October, 5, 2012

BREAKFAST ROUNDTABLE COORDINATORS Lori De Milto, MJ Writer for Rent, LLC, Sicklerville, NJ Michelle Zakson, MS Amgen Inc, Thousand Oaks, CA NETWORKING EVENT COORDINATOR Scott C. Thompson, ELS Medtronic, Spinal and Biologics, Memphis, TN KEYNOTE ADDRESS/MCGOVERN MEDAL CHAIRS Barbara Snyder, MA Warner Chilcott, LLC, Rockaway, NJ Melanie Fridl Ross, MSJ, ELS University of Florida Health Science Center, Gainesville, FL

Red Carpet & Cocktails 6:30 PM Dinner 7:00 PM Sheraton Grand Sacramento Tickets $55 » Register at amwa.org

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2011–2012 Executive Committee PRESIDENT Barbara R. Snyder, MA Warner Chilcott, LLC, Rockaway, NJ PRESIDENT-ELECT Douglas Haneline, PhD Ferris State University, Big Rapids, MI

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PUBLICATIONS ADMINISTRATOR Anne Marie Weber-Main, PhD University of Minnesota, Minneapolis, MN SPECIAL PROJECTS/COMMUNICATIONS ADMINISTRATOR Tamara D. Ball, MD i3 Statprobe, Asheville, NC

IMMEDIATE PAST PRESIDENT Melanie Fridl Ross, MSJ, ELS University of Florida Health Science Center, Gainesville, FL

WEB AND INTERNET TECHNOLOGY ADMINISTRATOR Kristina M. Wasson-Blader, PhD KWB Health Communications, Inc., Edmond, OK

SECRETARY Karen Potvin Klein, MA, ELS Wake Forest University Health Sciences, Winston-Salem, NC

AMWA Staff

TREASURER Judith M. Pepin, PhD The Procter & Gamble Co, Mason, OH 2012 ANNUAL CONFERENCE ADMINISTRATOR Brian Bass Bass Advertising & Marketing, Inc., Robbinsville, NJ ANNUAL CONFERENCE WORKSHOP COORDINATOR Jennifer Grodberg, PhD, RAC Trius Therapeutics Inc, San Diego, CA AWARDS ADMINISTRATOR Stephen N. Palmer, PhD, ELS Texas Heart Institute at St Luke’s Episcopal Hospital, Houston, TX CHAPTERS/MEMBERSHIP ADMINISTRATOR Katharyn Spiegel, PhD Amgen, Grass Lake, MI EDUCATION ADMINISTRATOR Sharon L. Nancekivell, MA Freelance Medical Editor, Guelph, ON, Canada

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Executive Director Susan Krug, CAE Deputy Director Shari Rager, CAE Education Manager Dane Russo Conference & Education Coordinator Becky Phillips Conference & Education Assistant Melanie Canahuate Member Services & Database Coordinator Mark Rosol

Membership & Publications Coordinator Rachel Spassiani, MA Staff Accountant & Benefits Administrator Carol Griffin, MS

AMWA

AMWA’s Certificate Program AMWA workshops allow medical communicators to increase their knowledge, refresh their skills, and investigate new areas. Registrants may take credit workshops without enrolling in a certificate program but must be enrolled in the specific certificate program to which the workshop is applicable to receive credit toward that certificate. Registrants may enroll in one or more of the certificate programs when they register for the annual conference. After enrolling, participants have 6 years to complete the workshop requirements for any certificate.

Workshops may be taken in any order during that time.

If a registrant is not enrolled in a certificate program but takes a workshop and wishes to receive credit for that workshop, enrollment in the certificate program to which the workshop is applicable must be received within 90 days (by December 28, 2012, for workshops taken at the 2012 Annual Conference). The registrant must also have successfully completed the homework and must have attended the entire workshop (3 hours).

People who were enrolled in the Core, Science Fundamentals, or Advanced certificate program before January 31, 2010, can complete their certificates within the specified enrollment time frame. Multiple designations are included in workshop listings to accommodate people enrolled in both new and old certificate programs.

For example, workshops designated SM/EW/SDT are currently applicable toward a Concepts in Science and Medicine certificate (designated SM), a Core certificate in editing/writing (EW), or a Science Fundamentals certificate (SDT). The credit can be applied only once, to 1 certificate.

AMWA only keeps records of credit workshops successfully completed by certificate program enrollees and awards the appropriate certificates when the requirements have been fulfilled. Please allow AMWA headquarters staff sufficient time after the conference to process the workshop credits.

2012

Enrollment is available for AMWA’s Essential Skills certificate, and 4 new specialty certificates: Business, Composition and Publication, Concepts in Science and Medicine, and Regulatory and Research. Earning a specialty certificate requires completion of an Essential Skills, Core, or Advanced certificate. The new certificates have replaced the previously offered Core and Science Fundamentals certificates but credits for workshops previously taken will not be lost; people can continue to pursue the previous certificates under their existing enrollment timeframe. Workshop listings include designations for both the new and old certificates.

Certificate Enrollment Fees

Member

Nonmember

Essential Skills

$150

$275

Business

$150

$275

Composition and Publication

$150

$275

Concepts in Science and Medicine

$150

$275

Regulatory and Research

$150

$275

Essential Skills certificate Essential Skills (ES) workshops provide the basis for the certificate program and include skills that all medical communicators should have, regardless of job function or environment. To obtain the Essential Skills certificate, 8 workshops must be successfully completed; one of the workshops must be the Essential Ethics for Medical Communicators. Two sessions of the workshop will be offered in Sacramento, and an Essential Skills self-study module will be available for conference attendees to purchase at a discounted price.

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AMWA’s Certificate Program Specialty certificates To receive a Business, Composition and Publication, Concepts in Science and Medicine, or a Regulatory and Research certificate, a participant must have successfully earned an Essential Skills, Core, or Advanced certificate and then completed 8 workshops; one of the workshops must be the ethics workshop applicable to that specialty. One new ethics workshop is being offered for the first time at the 2012 conference: Business Ethics for Medical Communicators (B). Essential Ethics for Medical Communicators (ES); Ethical Standards in Medical Publication (CP); Ethics in Communicating Science and Medicine (SM); Ethics in Communicating Regulated Drug Development Activities (RR); and Fundamentals of Ethics and Practical Applications (RR) are also being offered.

Specialty workshops 1. Business (B) workshops provide information to develop and expand freelance businesses, as well as providing management and operation skills for medical communicators.

2. Composition and Publication (CP) workshops provide experienced medical communicators with specialized editing and publication skills, as well as in-depth consideration of issues in writing, editing, bibliographic research, education, and other topics of interest.

3. Concepts in Science and Medicine (SM) workshops provide medical communicators with an opportunity to deepen their understanding of basic concepts in science and medicine. For those who are educated in nonscience fields, the workshops provide an orientation to a scientific area and a foundation for further study. The workshops can provide those educated in science with opportunities to increase their knowledge and to learn about areas outside their specialties.

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2012

4. Regulatory and Research (RR) workshops provide experienced medical communicators with specialized regulatory and drug development writing and research skills.

Workshop designations Credit for a workshop can be applied only once and workshops are given a designation that reflects the certificate program to which they currently apply. (A full list of abbreviations can be found on page 15.)

Noncredit (NC) workshops are not part of the certificate program, but they are also appropriate for all medical communicators seeking to increase their knowledge and refresh their skills. In addition, they are regularly evaluated, and some could be incorporated into the certificate program in the future.

Registering for workshops at the AMWA Annual Conference Participants who intend to take workshops for credit must submit a properly completed registration on or before September 5. This deadline is to allow time for AMWA headquarters staff to send registrants their homework and time for registrants to complete the homework assignments and return them to the workshop leaders by the due date of September 13 (see below).

AMWA’s credit workshops have permanent numbers, which follow [in brackets] the title of the workshop. If certificate program enrollees are uncertain about whether they have taken particular workshops, members can access their certificate records at AMWA’s website to compare the permanent numbers in the registration brochure against their records.

AMWA’s Certificate Program Homework Each credit workshop includes homework. Typically, the purpose of the homework is to give participants needed background information for the workshop or to help the workshop leader assess the skill levels of participants.

Once the registration has been processed, the registrant will be e-mailed the confirmation, including the URL and password for downloading electronic homework from the Web. Almost all homework for credit workshops is available electronically. Registrants are strongly encouraged to download homework immediately upon receipt of their confirmation to make sure the downloading process is successful, to ensure that the correct homework has been sent, and to note the deadline stated on the specific homework. A delay in downloading the homework and identifying potential problems could result in inability to complete the homework by the deadline. If the homework is not available electronically, a hard copy will be included in a mailed confirmation packet.

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Registrants should notify AMWA headquarters if they have not received the homework or URL and password within 10 days of registering for the conference: phone (301) 294-5303, fax (301) 294-9006, or e-mail dane@ amwa.org. Registrants are also responsible for verifying that workshop leaders have received the completed homework by the deadline. Credit for the workshop will not be given if the homework arrives late. Completed homework for workshops must be received by the workshop leader by September 13 unless an earlier deadline is indicated by the workshop leader on the homework.

Even if a registrant is not taking a workshop for credit, he or she should consider completing the homework to be better prepared to fully participate in the workshop.

So that all registrants for an Advanced workshop are prepared to participate in the discussions, each registrant is required to complete the homework and submit it to the workshop leader by the deadline, regardless of whether the registrant is taking the workshop for credit. If a registrant’s homework for an Advanced workshop is not received by the deadline, he or she will not be allowed to attend the workshop, and no workshop credit or refund will be given.

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Program Descriptions & Presenter Information Roundtables » THURSDAY, October 4, 7:30-8:45 AM T-01 What Doctors Really Want to Know: Increasing the Likelihood of Publication in a Clinical Journal Tami Ball, MD, Principal Medical Writer, PharmaNet-i3, Asheville, NC

This roundtable is intended for those new to writing for physician audiences, and especially for those writing manuscripts intended for publication in clinically-oriented journals. This brief presentation will include an orientation to the clinician’s background and use of the medical literature, and how that translates to each section of a manuscript. Plenty of time will be allowed for table-wide sharing of tips and tricks of the trade.

T-02 Establishing a Web Presence with Your Own Domain Name and Website Jean Bedord, www.Bedord.com

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T-06 Benefits and Roles of Having an Editor on the Writing Team David Clingan,Pharmanet/i3, San Antonio, TX

What does an editor add to the team? What is their focus compared to a writers? At what point should an editor be brought into a project? How can their value be measured? What are their biggest challenges?

T-07

Tools and Strategies for Enhanced Productivity

Roberta Connelly, MS, ELS, Principal, Ridge Rim Associates, LLC

Potential benefits of structuring your day, various approaches to constructing to-do lists, maintaining focus despite interruptions, whether and how to separate work from personal projects, using mobile devices to improve productivity T-08 How to Rock Conference Coverage (While Maintaining Sanity)

Importance of a domain name for branding, Steps in registering your own domain name, Alternatives for setting up websites, Role of social media vs. website, Expectations for generating business with a website

Michelle Dalton, ELS, Founder, Dalton & Associates, Reading, PA

T-03

T-09 Tips for Conducting an Effective and Focused Document Review Meeting

Making the Most of Microsoft Word 2010

Melissa L. Bogen, ELS, Bogen Editorial Services, Chester, NY

Intros, Word set-up and macros (Word version 2010), Resources, Creating fast/hot keys, including instructions for Mac and PC T-04 What Really Is Networking? How Can Seasoned Medical Writers Benefit from It? Tracy E Bunting-Early, PhD, Tracy E Bunting PhD, Inc, Landenberg, PA

1) What is the applied definition of networking, really? 2) What should one’s goal(s) for networking be? 3) What are the tools and tactics both new and old? 4) How to develop your networking strategy. 5) Is my strategy working?

T-05 Onboarding Medical Writers—Helping New Writers to Quickly Become Productive, Efficient, and Credible Leaders of the Writing Team Caryl Burke, PharmaNet/i3, Ann Arbor, MI

What is the value of a robust onboarding program? What are the important elements? What is the manager’s role vs the mentor’s, and how do they complement each other? What are the challenges to implementing a robust onboarding program?

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What conference coverage looks like, What skills are needed, Pros/cons to this type of work, Deciding what to cover, Typical workloads and typical pay structures

Noelle H. Demas, MS, Independent Medical Writing Consultant, Panorama MedWriters Group, Inc.

1. Preparation (focused agenda, logistics, meeting participants), 2. Facilitation guidelines, 3. Contributions as a leader, 4. Handling unproductive behaviors, 5. Taking effective meeting minutes T-10 Fostering Successful Partnerships Between Editors and Authors at Academic Medical Centers Stephanie Deming, Scientific Editor, Department of Scientific Publications, The University of Texas MD Anderson Cancer Center, Houston, TX

Starting off on the right foot is critically important, New authors require special attention, Editors should seek help from authors in understanding the authors’ research, Respect for the author is critical, To avoid becoming overwhelmed, editors must set limits T-11 Writing the Meaningful Informed Consent for the Research Participant Michelle Eby, Pharm.D, CCRP, Food and Drug Administration

Program Descriptions & Presenter Information 1. How templates, lay term databases, and IRB approved language can aid the writing process. 2. Describing side effects in lay terms. 3. Using unambiguous language to facilitate autonomous decision making. 4. Discuss the merits of readability formulas. 5. Use of text, graphics, and white space to make a user friendly document.

T-12 Social Media in Pharmaceutical Medical Communication: Myth and Reality Judith R. Farrar, PhD, Editor-in-Chief, Life Sciences Press, Canandaigua, NY

What is the role of social media/digital technology in medical communications today, and what should it be tomorrow? How should social media/digital technology be used to optimize information output and educational programming? What options are currently available for social media/ digital technology? How is social media/digital technology currently regulated? What is likely to change (or not)? What are some examples of “best use” of social media/digital technology? And what are some examples that give social media/digital technology a bad name?

T-13 Advanced Marketing: Using A Database and Virtual Assistant to Boost Your Business

T-15

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Certification of Editors in the Life Sciences

Norman Grossblatt, Senior Editor, The National Academies, Washington, DC

Origin of the program, Purpose of the program, What the credentialing examination consists of, How to apply for certification, Benefits of certification T-16

Going All Digital With Your Reference Binder

Darlene Grzegorski, MS, Tinton Falls, NJ

Different ways to make a PDF, How to use the markup tools in Adobe Acrobat for annotation, Merging multiple PDFs verus making a PDF portfolio, Troubleshooting uncooperative PDFs T-17

Freelance Writing for the Medical Device Industry

Jim Hudson, Partner, Medical Writing Associates, Simi Valley, CA

How do I segue into being a freelance for medical devices?

How does the medical device industry differ from big pharma?

How does FDA’s CDRH (device center) differ from CDER (drug center) and CBER (biologic center)? What influences might the European Union have on document creation? What’s a good strategy for obtaining job leads?

Debra Gordon, MS, President, GordonSquared, Inc, Williamsburg, VA

T-18

Want to consistently earn 6 figures a year? Then you owe it to yourself and your business to sign up for this breakfast roundtable. Veteran medical writer (consumer and scientific) Debra Gordon, MS will take you through some less-than-obvious approaches to take your business to the next level, including using a database and virtual assistant.

The importance of planning ahead, Identifying needs—equipment, software, office space, Marketing and networking—how much and how often?, Understanding contracts and expectations—theirs and yours, Setting boundaries

T-14 Evaluating Roles and Responsibilities for Medical Writers: Employer and Employee Perspectives Lori Gorton, PhD, Amgen Inc., Thousand Oaks, CA

1) Breadth vs depth: Working across several therapeutic areas or focusing on one; 2) Project driver: Who is responsible for timelines, document retention, and author interactions? medical writer or publication project manager and/or administrator; 3) Time allocation: Balancing time and resources for training and meeting attendance with quality and career development; 4) Project ownership and scope: One medical writer or several medical writers per project; 5) Medical writer’s contribution: Authority to incorporate (or not) internal or external comments on a given project without being an author.

Freelancing Lessons Learned

Tara Hun-Dorris, MMC, ELS; THD Editorial, Inc.; Raleigh, NC

T-19 How to Write a Book Proposal (for a HealthRelated Book) Ada P. Kahn, Ph.D, Author, Wordscope Associates, Evanston, Il

Why write a book proposal What are the basic elements of the book proposal? What sample material should be included? How to find a publisher and/or an agent Marketing your book after publication T-20

Writing Science for Children and Young Adults

Evelyn B. Kelly, PhD., Freelance writer, Kelly Communications, Ocala, FL

Why should you write for children? What are the age groups and types of writing that appeal to specific groups of children and young adults? What are the market possibilities in writing for magazines and books? Are there other markets, such as text books and museums? How do I begin?

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Program Descriptions & Presenter Information T-21

Canceled

T-26

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Medical Marketing the Science Behind the Story

Elizabeth Ramicone, Freelance Medical Marketing Writer, Columbus, OH

T-22 How to Succeed in Freelance Medical Writing Without a Scientific Background Donna L. Miceli, DLM Writing Services, Ft Myers, FL

Exploring the current climate for freelance medical writers (eg: Has the recent concern about “ghostwriting” made potential clients less likely to “take a chance” on a writer who does not have a scientific background?) Recognizing potential markets Understanding your strengths and limitations Learning about medicine (eg: taking courses, gathering a library of reference materials, etc.) Choosing/developing writing samples Convincing clients (“I can do it”) T-23 Instituting Necessary Measures for a New Organization Barbara A. Nambu, PhD, Medical Communications Writer, DaVita Clinical Research, Deerfield Beach, FL

Which environment is more suitable for your personality and professional career? What are the benefits of working remotely? What are the benefits of working in a business office environment? Does working remotely limit my career advancement opportunities? Are you interested in making this transition? If so, then how?

T-24 Applying Plain Language Principles in Patient Education Materials Beverly Parker, Managing Editor, Section of Patient Education, Mayo Clinic, Rochester, MN

1. The reasons writing in plain language is crucial to patients and health care providers, 2. Winning support for plain language in your institution—sharing evidence; doing your homework, 3. Setting standards to measure the effectiveness of plain language writing, 4. Obstacles you may confront as you write in plain language, 5. Making design part of your plain language plan T-25 Checking It Twice…Gonna Make Sure QA’s Not Naughty But Nice Jodi Pollock, i3global, Blue Bell, PA

1. Why a checklist? 2. What makes an effective checklist?

3. Who needs a checklist? 4. Who should create the checklist?

5. How do you sell the idea to your client?

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The promotional planning process, Communication components of a drug or device product launch, How the science dictates content development, The role of the medical marketing writer in a product launch T-27 Internal Marketing: How Newer Freelancers Can Keep Clients Coming Back Faith Reidenbach, Caley-Reidenbach Consulting, LLP, Philomath, OR

How do you make clients aware of what else you can do (subject matter–wise and media-wise) besides the types of projects they’ve assigned to you? How can you stay in touch with clients who haven’t called for a while without seeming to be desperate? How can you track down a client who left the company you worked with? I’ve found that if a prospective new client calls and I can’t schedule their work, I’ll probably never hear from them again. How do you deal with this situation? What are some do’s and don’ts of client relations that can set a medical communicator apart from the others?

T-28

Publishing a Physician-Targeted Newsletter

Jude Richard, ELS, Synchrogenix Information Strategies Inc., Austin, TX

Identifying the audience, Setting the budget, Assembling the editorial team, Naming the publication, Designing the publication’s overall format, Setting production and publication schedules, Deciding on content and assigning stories, Editing, reviewing, and approving content, Laying out content, Proofing and final approval in press, Mailing and distribution, Feedback and follow-up T-29

ClinicalTrials.gov Posting for Beginners

Christina Sacro, Sanofi, Bridgewater, NJ

Public Disclosure background, FDAAA requirements and Sanofi public disclosure policy, Disclosure of results T-30

Ins and Outs of Working With Japanese Authors

Lee Seaman, Seaman Medical, Inc., Bellingham, WA

1. Types of work (working with end users on journal submissions or regulatory writing, work from translation agencies and medical writing/editing agencies), 2. Building and maintaining a professional working relationship (esp. communicating effectively through e-mail), 3. Finding the right level of quality (“best” editing is not necessarily right for every job), 4. Nitty-

Program Descriptions & Presenter Information gritty points (finding work, sending invoices, managing taxes, getting paid) T-31 Be All That You Can: Professional Certifications, Educational Opportunities, and Programs of Interest to Biomedical Communicators Jill Shuman, MS, ELS, Principle, JSA Consultants, Boston MA

Filling in the Educational/Experience Gaps, What Credentials can Differentiate You from Your Peers?, Differentiating between Certification (Credentialing) and Certificate Programs, Overview of Professional Certification/Credentialing Programs, Overview of Professional Certificate Programs, Overview of Universitybased Degree and Certificate Programs T-32 Quality Control Feedback on Documents for Submission Michael Smith, Clinical Documentation, Senior Quality Control Specialist, Sanofi

What is Quality Control? Why do we need it? How is it done?

What new innovations are being explored? How does this lead to feedback on submission documents?

T-33

Electronic Archiving for the Home Office

Katharyn (Kathy) Spiegel, PhD, Amgen Inc, Grass Lake, MI

Backup versus archiving, Software solutions for cataloguing your files, Software solutions for archiving emails, Hardware options and issues, Archiving for the home office versus the larger business office T-34 Effective Communication Between Medical Writer and the Scientific/Technical Mindset

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to repeat. Think outside the box! A good newsletter title should be relevant and hint to the content and/or target audience. Design–Discussion on the advantages and disadvantages to layout design using an existing template vs a ‘blank canvas’. I will also provide tips on how to subtly incorporate your company’s color motif and overall ‘feel’ into your design. Content–What information does your audience want, and what is the best way to communicate that message? I will offer guidance on how to create a newsletter outline, deal with sensitive or confidential information, and how to complement your content with copyright-free images and other available references. Execution–Pros and cons to the most commonly used tools to create a newsletter (e.g. InDesign, PhotoShop, PowerPoint). Deadlines–How to set timelines that are reasonable and allow yourself time to receive necessary sign-offs/approvals, and tips on how to deal with non-responsive or perpetually late sign-offs.

T-36 Contract Research Organization Writing Opportunities: It’s More Than Just Regulatory Cindy van Dijk, Principal, Scientific Communications, Havelock, NC

I. Introductions, Meet & Greet: Expectations and Experience.

II. Non-regulatory writing opportunities in CROs: Anatomy of a CRO, Types of writing opportunities, Major/minor players and the “space” in which they work: Full service players, Niche Markets, How to target (what job titles), Overview of journals/ trades and useful websites, Useful references. III. Open up Discussion: Share any experiences of this target segment, Ideas for cold-calling T-37 Grantsmanship 101: Tips for Writing and Editing an NIH Grant

Dikran Toroser, PhD, Amgen, Thousand Oaks, CA

Kristina Wasson-Blader, PhD, ELS, President, KWB Health Communications, Inc., Edmond, OK

1. Building from the positive feedback from the last few years, I will expand on the learnings from previous attendees, 2. Ingredients needed to providing synergy between the medical writer and the person with a tech. mindset, 3. Capturing feedback from the technical stakeholder, 4. Soliciting feedback from the technical stakeholder.

How active is your voice? How specific are your aims? Is a picture really “worth a thousand words?” Is white space even possible in 12 pages? Does the proposal stand up to the “Miss Congeniality” test?

T-38 Writing for the Medical Device Industry: The Example of the Cardiac Device Market Christine Welniak, Upside Communications, Brooklyn, NY

T-35 Anatomy of a Newsletter: Design, Content and Delivery to a Health Care and Research Audience Jerome Valero, Communications Officer, University Health Network, Toronto, Ontario, Canada

Brainstorm ideas to create something catchy, inventive and easy

Why a device over a drug and what drives adoption of a medical device? Learn about these topics as well as the allimportant referral pathway among physicians, how medical device trials differ from pharma and how medical devices are reimbursed.

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Program Descriptions & Presenter Information T-39 Benefits of Publication Standard Operating Procedures Michelle Zakson, Amgen, Thousand Oaks, CA

What is a Publication SOP? Why have a Publication SOP? What are the best practices for a publication? Are there any benefits to following a SOP? Would we want a more/less stringent SOP in place?

T-40 Working for the Diagnostics and Biotechnology Industries: Which One is the Right Fit for You? Jenilyn Virrey, PhD, Amgen, Inc., Thousand Oaks, CA

The diagnostics and biotechnology industries offer different types of opportunities for those interested in medical communications. When choosing which industry to pursue, it is important to understand the differences between the two work environments. In this roundtable, we will share experiences in working for both industries and will discuss tips on effectively transitioning from one industry to the other.

Roundtables Âť SATURDAY, October 6, 7:30-8:45 AM S-01 Effective Presentation Skills: From Audience Analysis Through Delivery Stephanie Roberson Barnard Listen Write Present LLC, Wilson, NC

1. What kinds of presentations do you give? 2. What is the purpose of these talks and who is your audience? 3. What is the most important information you wish to convey? 4. What kinds of challenges do you face when you present? 5. What delivery skills do you need to refine?

S-02 FDA GMP Basics In Medical Writing and Manufacturing James C. (Chris) Barnett, Medical Writer II / Technical Writer, PharmaNet i3, Blue Bell, PA

1. What are the fundamentals of the FDA GMPs? How they apply in Medical Writing and Manufacturing. Why do I as a Medical Writer need to be concerned with GMPs? What effects can non-compliance in Medical Writing produce? Why are the GMPs so important?

S-03

Where Do Drug Names Come From?

Kristi Boehm, MS, Spring, TX

1. The different classifications and types of drug names, 2.

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What agencies are accountable for generic and trade names, 3. The basic process of naming a drug, 4. The many ways that drugs are named, 5. How to avoid confusing drug names S-04

Managing Medical Writers Remotely

Heidi Chapman, PharmaNet/i3, Ann Arbor, MI

Modes of working remotely (eg home-based vs office-based in remote locations), Motivation, Communication, Feeling like part of the team, Career development and job satisfaction, Systems access, Training, Detecting and dealing with performance issues S-05 Using Public Relations to Promote Medical Discoveries, Programs and Services Katrina R. Burton, BS, External Communications, MD Anderson Cancer Center, Houston, TX

Developing the communications outreach plan, Pulling the team together to launch the campaign, Establishing timelines for getting your message out, Engaging institutional leadership, medical experts and the media, Sharing metrics to show success.

S-06 Going Public: Setting Up an Internet Presence for Your Freelance Business Suzanne R. Canada, Ph. D., Owner and Proprietor, Tanager Medical Writing, LLC, Union City, CA

Venues for setting up a public business presence: LinkedIn, Websites, and public listings (such as the Freelance directory).

What are the basic items a writer should gather/display? How your strategy can determine your design. Privacy: how can you keep the public persona separate from your personal life?

Assessing and refreshing; and a little about Search Engine optimization.

S-07

Making the Most of Your LinkedIn Profile

Christine Durst, PhD, Durst Writing Solutions, Swarthmore, PA

You probably already have a basic LinkedIn profile, but you may not know all the ways to use it to your best advantage. In this interactive discussion, I will share and invite tips on drawing attention to your profile, finding out who has viewed it, improving your search engine placement, signing up for events (eg, AMWA conferences), highlighting certifications (eg., AMWA certificates), profiling specific projects you want clients and/or recruiters to know about, and more!

Program Descriptions & Presenter Information

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2012

S-08 The Nonclinical Regulatory Package: What is It, How Does It Fit In, Where is It Necessary, and Who are the Key Contributors and Partners?

organizational tips, must-have software, and cloud-based computing, as well as how to recognize and eliminate time wasters.

J. Nicole Earnhardt, PhD, Regulatory Submission Expert, Worldwide Research & Development, Pfizer, Inc., San Diego, CA

S-13 Covering a Congress for Your Pharmaceutical Company

1. The core components of a nonclinical regulatory package.

2. Interdependencies between nonclinical, quality, and clinical study and submission components.3. Nonclinical contributions to global regulatory submissions. 4. General responsibilities of the nonclinical regulatory writer. 5. Key partnerships.

Kerri Hebard-Massey, Amgen Inc., Thousand Oaks, CA

S-09 Medical Editing: From Copy Editing to Developmental Editing Tracey Fine, Fine Biomedical Communications, Inc., Chapel Hill, NC

Pre-Conference Preparation, Logistics, Daily Debrief and Information Gathering, Writing Daily Summaries , Overall Meeting Summaries: How Much Time Should You Spend on Them?

S-14 Creating Quality Clinical Summaries When Timelines are Tight Michael L. Jones, Director, Medical Writing, TKL Research, Inc., Rochelle Park, NJ

1. Mechanical editing vs technical editing. 2. Why levels of editing for technical / scientific documents differ by organization. 3.

How levels of editing differ by technical/scientific organization.

4. How using levels of editing can improve workflow and the author–editor relationship. 5. How to help authors determine the appropriate level of editing for their document.

1. Use of Table Shells: Can often be used for more than one report. 2. Overall Report Process from Shell to Final Sign-off 3. Sample Timeline 4. Streamlining the Review Process 5. QC Checklist

S-10

Kelly Killian, MA, Medical Writer/Editor, ARUP Laboratories, Salt Lake City, UT

Opportunities for Nurse Writers

Jacalyn P. Dougherty, PhD, RN, Research & Writing Consultant, JP Dougherty LLC, Aurora, CO

1. Skills nurses bring to medical writing 2. Obstacles to a career in medical writing (including lack of formal education in writing, potential lack of an advanced degree) 3. How to build your writing resume and portfolio 4. Potential markets 5. Selling your skills to potential clients S-11 Medical Journalism Do’s & Don’ts: Tips for Successful Writing and Reporting Barbara Gastel, MD, MPH, Texas A&M University, College Station, TX

1. finding information to consider including in magazine articles and other journalistic medical writing, 2. evaluating the information, 3. structuring a piece of journalistic medical writing, 4. wording the piece: sensitivity and style, 5. coping with ethical issues that can arise in doing journalistic medical writing S-12 Time Essentials. How to Use Technology and Other Tools to Work Faster and Better

S-15 Making Every Word Count: Creating a Novel Online Medical Information Source

Strategies for presenting conceptually dense but concise information for medical audiences with varied expertise. Using constant comparative methods for developing style guide and fine-tuning presentation. Applying writing group principles to the editorial process. Maintaining content integrity and planning for the unknown. Strategies for engaging a reluctant reviewer.

S-16

Introduction to Narrative Medicine

Lauralee Leonard, Independent Medical Writer, Rasulo Leonard LLC, Princeton, NJ

Narrative medicine is an emerging interdisciplinary field dedicated to the improvement of health care by the application of narrative training. Discussion points include: theory and development of narrative methods as part of the health care experience; medicine and story: literature as an opportunity to enhance communication skills; the combined technique of close reading and reflective writing; the narrative medicine workshop; current uses and future possibilities.

Debra Gordon, MS, President, GordonSquared, Inc, Williamsburg, VA

It’s the little things that can make a big difference in your work day. In this session, you’ll learn about some of them, including

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Program Descriptions & Presenter Information

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2012

S-17 Distance Education: Tips for Training Medical Writers from Afar

S-22 Transition From Benchtop to Medical Writing: Rethinking Your Experience

Rebecca Lew, PhD, CMPP, ProScribe Medical Communications

Yeshi Mikyas, PhD, ELS, Global Safety Senior Manager, Amgen Inc., Thousand Oaks, CA

1. Establishing relationships between teachers and adult learners, 2. Teaching and assessing writing skill /competencies, 3.

Teaching and assessing other skills/competencies, 4. Motivating adult learners, 5. Technology––a force for good or evil?

S-18 Understanding the Challenges of Global Medicines Development

Look at a few sample Medical Writing job listings to see what experience is required, Go through the exercise of mapping your experience with what is being asked for, Discuss ideas on how to put together a resume/CV that draws attention to your capabilities/expertise or your potential for the specific position

Lawrence Liberti, MS, RPh, Executive Director, CIRS-Centre for Innovation in Regulatory Science, Ltd., Holland, PA

S-23 Social Media in Pharmaceutical Medical Communication: Myth and Reality

Discussion of diversity/complexity of local regulatory requirements, Barriers and facilitators to interactions with regulatory agencies around the world, Regional harmonization initiativeswhat value do they add to global medicines development

Judi Miller, Strategic Pharmaceutical Advisors, Washington, DC

S-19 How to Write an Adverse Event Narrative for a Clinical Study Report Barbara Liptak, MS, Principal Medical Writer, TKL Research, Inc., Rochelle Park, NJ

What is a serious event or adverse event narrative? Why are they written, and for what purpose? Who writes narratives?

Templates. Sources of information for narratives.

S-20 Document Infrastructure: What it is and How to Create One Anthony Maine, Manager, Medical Writing, Icon Clinical Research, Longmont, CO

What does document infrastructure mean, The value of having a solid document infrastructure from practical, quality and business perspective, The elements of document infrastructure, The best way to create a strong infrastructure, Do you or your company have a document infrastructure S-21

Pitfalls in Preparing Informed Consent Forms

Dolores Massari, Director, Regulatory Affairs, Hurley Consulting Associates Ltd., Chatham, NJ

1. Confidentiality issues and subjects’ rights [Health Insurance Portability and Accountability Act of 1996 (HIPAA)], Consistency with the study protocol, investigator’s brochure, investigator guidelines, and other subject information, Regulatory requirements, Language as readable and nontechnical as practical, Revising the consent form

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1. What is the role of social media / digital technology in medical communications today, and what should it be tomorrow? How should social media / digital technology be used to optimize information output and educational programming?

What options are currently available for social media/ digital technology? How is social media / digital technology currently regulated? What is likely to change (or not)? What are some examples of “best use” of social media/digital technology? And what are some examples that give social media/digital technology a bad name?

S-24

Designing a Healthy, Comfortable Office

Phillip M. Murray, PhD, Freelance

1. Maladies of writers and other office workers. 2. Increasing comfort through a carefully designed, office plan will increase productivity and health. 3. Your chair is the most important piece of furniture in your office. 4. Less-common office hazards.

S-25

So, You Want to Take the BELS Exam?

Leslie E. Neistadt, ELS, Managing Editor, Journal of Athletic Training, Columbus, GA

Applying for candidacy and registering for an exam, Reasons for taking the exam, Topics covered on the exam, Suggested references to help you get ready, The single best way to prepare for the exam S-26 Creating Powerful Printed Reports (Newsletters, Annual Reports and More): From Concept Through Production Benjamin J. Pakuts, Msc., University Health Network, Research Communications, Toronto, ON, Canada

Program Descriptions & Presenter Information 1. Creative concept brainstorming, 2. Content mining and writing for your audience 3. Effective timelines: setting achievable goals, top-level tasks, and milestones 4. Improving readability 5. Basics of layout design 6. The printing process S-27

AMWA for Scientists and Clinicians

Stephen N. Palmer, PhD, ELS, The Texas Heart Institute at St. Luke’s Episcopal Hospital, Houston, TX

What made you decide to join AMWA? Is the experience what you expected? Which AMWA activities, services, or publications have been of most help to you? What aspects of AMWA could you take greater advantage of? How can AMWA serve you better?

S-28 How to Advance Your Medical Writer Career Through Blogging Nicola Parry, Parry Medical Writing, Shrewsbury, MA

Advantages of blogging; Where to begin if you’re completely new to blogging; Resources for images to add to your posts; Using your blog as an online portfolio; Using your blog as a marketing tool S-29 Continuous Improvement and Flexibility: Key Skills for Success in Today’s Job Market Lori Rochelle, PhD, Senior Medical Writer, PharmaNet/i3 , Durham, NC

1. When is what I know enough? 2. Value of on the job training opportunities vs. outside training 3. Making the most of what I already know 4. No cost strategies for staying current in the field 5. Which of my skills are transferable?

S-30

Using Checklists for More Efficient Editing

Kelly Schrank, Med Communications, Memphis, TN

Introductions, Who is using checklists for editing tasks? Were they provided to you or did you make them yourself? What do you think are the pros/cons of using checklists? Available Research/Advice, Reasons to Use Checklists S-31

Publication Planning in 2012

Gene P. Snyder, MBA, CMPP, President, FoxP2 Consulting

The publication landscape continues to evolve and sometimes navigating the landscape can be somewhat challenging and puzzling. Whether you are a publication planner or a professional medical writer, the rules are bountiful–the process of applying good publication practices for the reporting of research starts well before putting pen to paper. The presenter

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will review and discuss good publication practices (GPP) that should be applied daily by the medical communicator, discuss compliance with GPP, and show a spotlight on living in the World of Corporate Integrity Agreements. This session will be practical and provide tools that the medical communicator can apply everyday.

S-32

Do You Have the Skills for Regulatory Writing?

Kent Steinriede, MS, Medical Writer II, ICON Clinical Research

1. Skills needed: fast, clean writer, a good editor, a master of Microsoft Word, and a team player who’s not afraid to ask difficult questions on deadline 2. How regulatory writing is a lot like working at a newspaper, magazine or news website 3.

Specialty niches in regulatory writing: narratives, investigator brochures, clinical study reports, tables and graphs for data presentation 4. How to break into regulatory writing with little or no experience 5. Career paths for regulatory writers S-33 Multi-Investigator Grants: Multiple Migraines or Single, Manageable Headache?

Alexander Unterberger, PhD, University Health Network, Toronto, ON, Canada

Scheduling development of grant, identifying strong lead to correspond with (who may not necessarily be the principal applicant), organizing available resources to support application, defining one voice and one direction and dealing with difficult members/taming egos.

S-34

Biomarkers and Personalized Medicine 101

Cindy van Dijk, Principal, Scientific Communications, Havelock, NC

Personalized medicine (PM) is the tailoring of medical treatment to an individual’s biological conditions. This approach to medicine relies on our understanding of how a person’s unique molecular and genetic profile makes them susceptible (or not) to certain diseases and physiological conditions. Biomarkers are the integral tools by which a response or non-response to a particular therapy is predicted. This session will provide an overview of personalized medicine and biomarkers and will explore the opportunities available for medical writers in this field of study.

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Getting a Handle on Version Control

Martha Carroll Vollmer, MA, Publication Specialist, Global Scientific & Medical Publications, Merck Sharp & Dohme Corp., Whitehouse Station, NJ

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Program Descriptions & Presenter Information It can be easy to get overwhelmed with the number of revisions that come in from multiple authors. We’ll discuss strategies that professional medical writers use to make sure they always have the most current version of a document easily at hand.

Some tips include: Set limits on the number of revisions, do not allow copyediting at galley or layout stage; set a standard naming convention and stick to it; always allow changes to scientific data S-36 Highlights and Update on the Uniform Requirements for Manuscripts Submitted to Biomedical Journals Mary H. Whitman, MS, PhD, Senior Director, Medical Affairs, Janssen Biotech, Inc., Spring House, PA

Use of the International Committee of Medical Journal Editors disclosure form, Posting trial results on a public website, Ethical concerns in publishing S-37 Opportunities for Medical Writers in Study Data Review Jennifer Houser, CCRP, Seattle Genetics, Bothell, WA

Who normally leads a data review? What purpose does a data review serve? When do these types of reviews occur (where in the life of the study)? How will the data look? Why should a medical writer participate in a data review?

S-38 The Scientific Method – A Tool to Help Medical Writers be Flexible in Terms of Therapeutic Areas and Audience Helen Wilfehrt, PhD, DaVita Clinical Research, Minneapolis, MN

Which is more important to you – the scientific training or the writing expertise? What benefits are there to being a subject matter expert? What benefits are there to being the “naïve” scientist in the room? Have you made a transition from one field to another? Are you interested in making such a transition?

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Avoiding Plagiarism

Marie Fleisner, Marshfield Clinic Research Foundation, Marshfield, WI

What is plagiarism and self-plagiarism? As an editor/writer, how do you detect plagiarism? What can be done to avoid plagiarism? How do create proper citations in order to avoid plagiarism? What types of plagiarism-detection software are available?

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Open Sessions » THURSDAY, October 4 (see pages 16-18 for times) OS-01

So You Want to Write a Book?

Debra Gordon, MS, President, GordonSquared, Inc., Williamsburg, VA; Alisa Bowman, Writer, Emmaus, PA

Have you always wanted to write a book? This is the session for you. In this session, you’ll learn about the ins and outs of nonfiction book writing, including how to write a proposal; how to find an agent; the publishing business today; self-publishing; and, gasp! ghostwriting or co-authorship with physicians or other experts. Panelists Debra Gordon, MS, and Alisa Bowman have written more than 20 books between them, with and without other authors. After completing the program, attendees will be able to describe the book writing and publishing process.

OS-02 Words, Words, Words: Yours, Mine, or Someone Else’s?

LeAnn M. Stee, Head, Scientific Publications, Mayo Clinic, in Rochester, MN, and Administrator, Academic Support Office, Mayo Clinic in Arizona; Kenna Atherton, Manager, Scientific Publications, Mayo Clinic, Rochester, MN

Biomedical journals are increasingly using text-matching software to detect plagiarism, retractions are increasing, and the pressure to publish is unabated at academic medical institutions. Should these institutions make a text-matching service available or require their authors to use the text-matching software? If so, the questions are many: Who will own the process?

How will it work? Who will educate authors about plagiarism and in use of the software? Who will analyze and interpret the reports? What are the costs (both monetary and personnel)?

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If Looks Could Kill…Your Career

Alisa Bonsignore Writer and Strategist, Clarifying Complex Ideas, Pleasanton, CA; April Reynolds, MS, ELS, Independent Medical Writer and Editor, San Diego, CA

Last year, Alisa’s open session discussed how to present yourself professionally, both online and in person. April’s coffee klatch showed how to build a better work wardrobe. This year, we put the two elements together to show how to improve your client-facing appearance without breaking the bank. Professional attire, body-type dressing and current and appropriate trends for both women and men will be presented. You will

Program Descriptions & Presenter Information

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have the chance to interact and seek answers to questions about professional attire in an era where a formal suit can now look as much out of place as denim once did.

OS-06 Getting to the Next Level: Using Subcontracting and Mentoring to Create Your Team and Increase Your Revenue

OS-04 FDA Drug Safety Communications: Principles, Practice, and Evaluation

Debra Gordon, MS; President, GordonSquared, Inc. Williamsburg; Tracey E. Bunting-Early PhD, Owner, Outcomes+; Michelle Dalton ELS, Dalton & Associates, Reading PA; Caitlin Rothermel, MA, MPHc, MedLitera, Seattle, WA

Laura L. Pincock, PharmD, MPH, Commander, U.S. Public Health Service, Safety and Risk Communication Team Analyst Division of Health Communications Office of Communications FDA/CDER/OCOMM/DHC

The FDA uses Drug Safety Communications to inform the public about important new potential or established postmarket safety issues associated with marketed drugs. The risk communications act to inform health care professionals and patients so they make the best medical treatment decisions. This presentation will provide attendees with FDA’s framework for developing these communications, best practices used by the Agency for risk communication, and a description of FDA’s efforts to evaluate the effectiveness of its risk communication program.

Attendees will walk away with a greater understanding of how and why FDA issues Drug Safety Communications.

OS-05 Perspectives on the Challenges and Promise of Personalized Medicine Cynthia Carr, PhD, Senior Medical Writer, Ventana Medical Systems, Inc., a member of the Roche Group, Tucson, AZ; Julie Ann Sakowski, PhD, Associate Adjunct Professor-Department of Clinical Pharmacy University of California, San Francisco; Executive Director, UCSF Center for Translational and Policy Research on Personalized Medicine; Cindy van Dijk, Principal, Scientific Communications, Havelock, NC; Eric E. Walk, MD, FCAP, Senior Vice President and Chief Medical Officer, Ventana Medical Systems, Inc., a member of the Roche Group, Tucson, AZ

Once a dream, the concept of personalized medicine is now a reality and has become the strategic focus of many organizations. Armed with knowledge about the power of pairing pharmaceuticals with companion diagnostics, medical communicators can avail themselves to new and exciting writing opportunities. This session will provide an overview of translational diagnostics, highlight current technologies, and discuss the implications of these medical advances for patients and payers.

There comes a time in every successful freelance career when you can no longer go it alone. It’s time to call in the troops, i.e., subcontractors. In this panel, you will hear from freelancers who use subcontractors, and from freelancers who work for other freelancers. You’ll hear about what works, what doesn’t, and what will really get you in trouble.

OS-07 Beyond Belly Aches: Identifying and Differentiating Food Allergies and Intolerances Jeanette N. Keith, MD, Director of Gastroenterology and Bariatric Medicine at Cooper Green Mercy Hospital in Birmingham, AL; Roberta Larson Duyff, MS, RD, FADA, CFCS, Food and Nutrition Consultant, Author of the American Dietetic Association Complete Food and Nutrition Guide

Food sensitivities, including allergies and intolerances, can be difficult to identify and misdiagnoses can yield debilitating results. Though incidence of food sensitivities appears to be on the rise, effective solutions have never been more prevalent.

This session will closely examine research related to food allergies and intolerance with an emphasis on how to differentiate the two. After this presentation, a medical writer will be able to identify and discuss the latest research surrounding food sensitivities (specifically allergies and intolerances) including incidence in minority populations, recent studies, misdiagnosis and related statistics; distinguish between food allergies and intolerances and share smart solutions with their audience regarding effective treatment options to eat safely while maintaining nutrient needs and good health.

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FDA Dos and Don’ts of Advertising and Promotion

Lisa Hubbard, R.Ph., Group Leader, Division of Professional Promotion, Office Of Prescription Drug Promotion, FDA, Silver Spring, MD

Through interactive lecture, participants will receive an introduction to the Food and Drug Administration’s advertising regulatory authority (Office Of Prescription Drug Promotion, formerly DDMAC), understanding of drug promotion vs scientific exchange, and knowledge of FDA’s current thinking regarding unsolicited requests for medical information. Participants

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Program Descriptions & Presenter Information learn to recognize violations and how to avoid violations when preparing written materials.

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This session will allow participants to get acquainted with other conference-goers 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 move to a different table. Both newer and established members are encouraged to attend. This is NOT about job-hunting; participants will not be divided between job seekers and hiring managers. Rather, this session is designed to foster serendipity—you never know whom you’ll meet, what interests you’ll share, and whether you might develop a business relationship or a friendship! Bring lots of business cards.

The FDA as an Audience

Debra Hathaway, THinc, Los Altos, CA

Understanding the FDA as audience is an important step in creating well-written regulatory documents. The benefits in this understanding are production of focused documents that may improve outcomes in meetings with the FDA and reduce the time and effort needed by the FDA during the IND and NDA/BLA review cycle. This session will cover resources available from the FDA’s website that can help you to understand the FDA’s perspective, reviewing and interpreting sample minutes from sponsors meetings with the FDA during different phases of development, and FDA medical reviews OS-11 How Well Do You Know HIPAA? What the Law Requires of Medical Communicators Kent Steinriede, MS, Medical Writer II, Icon Clinical Research, North Wales, PA; Kate Black, JD, Staff Counsel, Health Privacy, San Francisco, CA; Catherine Curran, Director of Public and Community Relations, Shriners Hospitals for Children

Northern California Health Insurance Portability and Accountability Act of 1996 (HIPAA) restricts the disclosure of individuals’ health information in order to protect patient privacy in a digital world. Learn how medical communicators can strike a balance between patient privacy and the flow of important health information to patients, the public, and health practitioners. Participants will learn what the HIPAA requires of medical

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communicators and how they can work within the law to get proper consent to use a patient’s identity, story and image in medical communications.

Speed Networking

Faith Reidenbach, ELS, CMPP, Principal Caley-Reidenbach Consulting, Corvallis, OR

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OS-12 Accountable Care Organizations: Changing Health care Delivery and Providing New Medical Writing Opportunities Christine Welniak, Upside Communications, Brooklyn, NY Richard Angeloni, Director of Communications, Brown & Toland Physicians, San Francisco, CA; Cindy van Dijk, Scientific Communications, Havelock, NC

With the first Baby Boomers becoming Medicare eligible in 2011, the Centers for Medicare & Medicaid Services (CMS) is hoping to control Medicare costs through the use of accountable care organizations (ACOs). Implementation of ACOs began in earnest in January 2012. A representative from Brown & Toland, the only health care organization in northern California selected as a Pioneer ACO by Medicare, will speak about the needs of ACOs, including a higher level of communication among health care providers and the patients they serve. The launch of ACOs offer a plethora of new writing opportunities for medical writers, and include areas such as writing for patient education, implementation of health information technologies and the roll out of EHRs for data analytics and improving the quality of care delivered to patients.

OS-13

How To Get Your Second Medical Writing Job

Heather Haley, Medical Writer Haley Writing Solutions, Cincinnati, OH; Hilary Graham, Coordinator of Department Publications, MD Anderson Cancer Center, Smithville, TX; Hope J. Lafferty, AM, ELS, Hope Lafferty Communications, Marfa TX; Stephen To, Documentation Specialist, Hoffmann-La Roche, New York, NY; Michael Mihm, Associate Director, Medical Writing, Strategic Resourcing, Pharmanet I-3

Career development is a challenging area for medical writers.

When we are discontent in our professional lives, we often are challenged to identify whether it is an individual situation or the nature of the work. In this interactive moderated panel session, experience medical writers who have switched professional settings will share their experiences on getting the second medical writing job. Additionally, a hiring manager will speak to how experienced writers can position better themselves for their next career opportunity.

Program Descriptions & Presenter Information Open Sessions » FRIDAY, October 5 (see pages 19-21 for times) OS-14

Health Care Reform for Dummies

Debra Gordon, MS, President, GordonSquared, Inc., Williamsburg, VA

If you’ve ever wanted to know about accountable care organizations, patient-centered medical homes, Medicare, Medicaid, managed care, pay-for-performance, the numerous other components of today’s health care system—including the Affordable Care Act—then this is the session for you. You’ll learn about the components of health care reform, its impact on hospitals, physicians, and other health care providers, and, most importantly, how all this affects medical writers, both freelance and those working in medical communication companies.

After completing this session, attendees will be able to describe key provisions of health care reform and their potential impact on medical writers.

OS-15 Evidence-Based Medical Writing: Shaping Your Readers’ Experience Lori L. Alexander, MTPW, ELS, President, Editorial Rx Inc, Orange Park, FL; Cynthia M. Shaler, Owner, Cynthia M Shaler, Consultant, Boalsburg, PA; Cherie Woodward, Contract Technical Content Developer, CoolText, Cool, CA

What are the most effective ways to enhance readers’ comprehension in written and electronic communication and why are those methods effective? This session provides an overview of evidence-based writing that can be applied to medical writing in any setting. Attendees will have the unique opportunity to learn about the 25 evidence-based principles in Guidelines for Document Design, originally published in 1981 to provide guidance for developers of public documents. Using innovative approaches, speakers will present each principle, discuss its application to writing for both professional and lay readers, and review the research base. The session also features an exploration of how delivery format affects comprehension and a discussion of ways to create effective documentation for the Web and smart appliances.

OS-16 After the Gold Rush: NLM and Gold Nuggets of Information!

Kelli Ham, MLIS, Consumer Health & Technology Coordinator, Pacific Southwest Regional Medical Library, National Network of Libraries of Medicine, at the UCLA Louise M. Darling Biomedical Library, Los Angeles, CA

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An experienced medical librarian representing NLM will update you on the Library’s latest information innovations, involving apps, mobile sites, electronic health records and more.

Learn how to successfully search databases such as PubMed, MedlinePlus, ClinicalTrials.gov and PubMed Health. Bring your questions; our expert will have the answers for you.

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How to Talk to Your IT Department

Sunil Patel, Drug Safety Associate II, Onyx Pharmaceuticals, South San Francisco, CA; Ali Rezaian, BA, Senior Director, Information Technology, Onyx Pharmaceuticals, Member, Microsoft Mid-Sized CIO Advisory Council, South San Francisco, CA; Charles Wolfus, JD, Associate Director, IT Operations, Onyx Pharmaceuticals, South San Francisco, CA

As medical writers, we are skilled in communicating to a variety of audiences, from patients to doctors. So why is it so hard to talk to our IT department? In this session, two IT professionals with 20 years combined experience in the biotechnology industry (and a healthy sense of humor) will take you through the terminology and tactics that will allow you to communicate your issues to IT as well as understand their answers. Topics covered will range from the simple “Why doesn’t my computer work?” to the more complex “How do I send and store this large confidential file securely?”

OS-18 Negotiation for Medical Writers: The Mutual Gains Approach Joanne Rosenberg, MS. ELS; Carly Inkpen, Project Associate, Consensus Building Institute

Negotiating a contract? Haggling over content and wording with a co-author? This participatory workshop offers a process model for negotiation that focuses on reaching better, more sustainable agreements while preserving important relationships. Through a presentation and interactive exercises, participants will learn about a negotiation framework, receive tips for improving outcomes, and have a chance to apply the ideas in the context of medical writing.

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Leading a Protocol Development Project

Deana Betterton-Lewis, MS, RAC, Senior Medical Writer, PPD, Inc, Morrisville, NC

With large pharmaceutical companies outsourcing more and more of their clinical development work, medical writers may find themselves involved in protocol development. For medical writers experienced at writing clinical study reports but not protocols, this may present a unique challenge. Protocol

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Program Descriptions & Presenter Information development is much more of collaborative effort requiring the medical writer to write and edit, solicit input from functional area representatives (such as clinical, medical, regulatory affairs, statistics, clinical supplies, data management, and so forth) facilitate discussions among team members, drive for consensus during meetings, and lead the project to meet tight timelines.

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of diabetes and heart failure are expected to increase dramatically in the coming years. This session will familiarize medical writers about the continuum of care for these patients and include insights into emerging treatments, such as the artificial pancreas and a miniaturized heart pump, for patients who become refractory to medical therapy. Learn about these and other new technologies and the medical writing opportunities they’ll create!

Cause of Death: PowerPoint

Alisa Bonsignore Writer and Strategist, Clarifying Complex Ideas, Pleasanton, CA

OS-23 Professional Medical Communicators Beware: The Challenges and Pitfalls of Publication Planning in 2012

Your PowerPoint presentation doesn’t have to be an assault with a deadly weapon. This session will review the most common mistakes that presenters make: shoehorning 150 slides’ worth of information into 20 pages; text that can’t be seen from the back of the room; an unprepared presenter; and the obfuscation that often comes with presenting dry, clinical data.

By the end of the session, participants will approach their presentations with new eyes. Together, we can put an end to this senseless epidemic.

Gene P. Snyder, MBA, CMPP President FoxP2 Consulting LLC; Cara Coffey, CMPP, Lead, Consultancy Solutions, UBC-Envision Group

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Dial 911: Emergencies in Medical Writing

Anne Jacobson, MPH, CCMEP, Freelance Medical Writer, Cocoa Beach, FL

Scott Kober, MBA, CCMEP, Director, Content Development, Institute for Continuing Healthcare Education, Philadelphia, PA Eight to ten real-life scenarios will be presented that constituted an “emergency” in medical writing because they posed logistical, interpersonal, technological, or other unexpected challenges. Participants will be asked to brainstorm and suggest solutions to each emergency (either as one large group or as members of smaller discussion groups, depending on the number of participants). How each medical writing emergency was addressed, as well as the outcome, will be revealed. The session leaders will offer strategies for anticipating potential problems and developing effective solutions to medical writing.

The publication landscape continues to evolve, and sometimes navigating it can be challenging and puzzling. Whether you are a publication planner or a professional medical writer, the rules are many, and the process of applying good publication practices to the reporting of research starts well before putting pen to paper. The presenter will review good publication practices (GPP) that should be applied daily by the medical communicator, will discuss compliance with GPP, and will shed a spotlight on living in the world of Corporate Integrity Agreements. This session will be practical and will provide tools that the medical communicator can apply every day.

OS-24 Document Quality Control: A QCer’s View of the World Dianne De Jesus, Technical Editor, ICON Clinical Research, North Wales, PA

OS-22 Expanding the Continuum of Care: the Role of Medical Devices in Chronic Disease Management

In regulatory writing, quality control (QC) is a specific task that helps ensure that data presented in in-text tables is accurate, that the text reflects the data presented, and that the document conforms to the appropriate format. Quality control shouldn’t be confused with copy editing or peer review, which are other distinct tasks. This presentation will give attendees a good idea of what a QC specialist does and is looking for. Attendees will receive a checklist of things to look out for in documents in order to create clean documents for clients and, of course, QC specialists.

Caitlin Rothermel, MA, MPHc, MedLitera, Seattle, WA; Tim Peoples, MA, ELS, Senior Medical Writer, Medtronic, Inc, Goleta, CA; Christine Welniak, Upside Communications, Brooklyn, NY

OS-25 How to Benchmark Medical Writing: Is Faster, Cheaper, Better?

Medical professionals need to know about continuum of care for patients. As medical communicators, we should, as well.

With the aging population and obesity epidemic, the prevalence

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Thomas J. Purcell, MSPM, MSTC, Principal, Urtech Medical Writing & Consultancy, LLC, Saline, MI

Benchmarking is a tool for comparing one organization against

Program Descriptions & Presenter Information others to identify their comparative strengths and weaknesses and learn how to improve. Most benchmarking is a comparison of data-based scores and conventional performance indicators (unit costs, completion rates, etc.). Most of the early work in the area of benchmarking was done in manufacturing. Now benchmarking is a management tool that is being applied almost anywhere. The objective of benchmarking is to understand and evaluate the current position of an organization in relation to “best practice” and to identify areas and means of performance improvement. There are a number of different types of benchmarking. For medical writing, benchmarking usually is focused on two areas: process and performance. Process benchmarking almost always involves producing process maps to facilitate comparison and analysis in order to obtain quick gains. Performance benchmarking assesses relative level of performance in key activities in comparison with others in the same sector and finding ways of closing gaps in performance. Selecting the right metrics to measure for medical writing is problematic at best. Medical writing is an intellectual pursuit of transforming data to accessible knowledge in support of science. In quality management, a metric needs to translate customer needs into producer performance measures. An effective metric allows for actionable responses if the performance is unacceptable.

There is little value in a metric that identifies nonperformance if nothing can or will be done to remedy it. In practice, identifying effective metrics is often difficult. The main reason is that non-performance of a metric does not always lead to customer dissatisfaction. Developing key performance indicators for medical writing quality is clearly a challenge, mostly because the hard numbers presented by data quality tools are typically out of the business context.

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Scope of Medical Communications

Jim Hudson, Partner, Medical Writing Associates, Simi Valley, CA; MaryAnn Foote, PhD, MA Foote Associates and USC School of Pharmacy; Westlake Village, CA; Deborah Brown, BS, Independent PR/Marketing & Communications Specialist; ongoing contractor to Healthcare Success Strategies, Southern California; Johanna Lackner Marx, MPH, MSW, CCMEP; President and Founder, InQuill Medical Communications, LLC; Soquel, CA; Naomi L. Ruff, PhD, ELS; RuffDraft Communications; Duluth, MN

For those new to the field and those wanting to transfer to a new area of the profession, this presentation will provide an overview of medical communication from the perspectives of writers and editors working in different specialties and environments. Presenters will describe their work environment and

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discuss opportunities and projects in their specific fields, the necessary background and education, salary ranges, how to break in, and how to get ahead.

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The 90-Minute MBA for Freelance

Debra Gordon, MS; President, Gordon Squared, Inc. Williamsburg VA; Scott Kober, MBA, CCMEP, Director, Content Development , Institute for Continuing Healthcare Education, Philadelphia, PA; Roger T. Smith, CFP, CPWA Financial Advisor, Planned Solutions, Inc. Sacramento CA

In this session, you will hear from a newly minted MBA (who also happens to be a medical writer) about how to take what he’s learned in his MBA program and apply it to your business: marketing, entrepreneurship, operations management, and financial reporting. You will also hear from a freelancer about how she applies such best practices to her own business, and from a financial advisor about insurance, retirement planning, and other important issues that every freelance medical writer-including you—should know to run a successful business.

Participants will also learn how to conduct their own SWOT analysis and put the results into immediate practice when they return to work.

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Genetic Testing: Today and Tomorrow

Sunil Patel, Drug Safety Associate II, Onyx Pharmaceuticals; James M. Ford, MD, Director, Clinical Cancer Genetics Program, Stanford University School of Medicine; Associate Professor of Medicine and Genetics, Division of Oncology ;Henry T. Greely, Deane F. and Kate Edelman

Johnson Professor of Law, Professor (by courtesy) of Genetics, Stanford University, Director, Stanford Center for Law and the Biosciences; Kelly E. Ormond, MS, CGC, LGC; Director, MS in Human Genetics and Genetic Counseling, Stanford University In the early 1970s, a prenatal test for Down syndrome was discovered. Today, genetic testing can predict or diagnose a variety of diseases from diabetes to cancer. This session will provide an overview of genetic testing and current technologies, including whole genome sequencing. We will lay out clinical scenarios and discuss the implications of direct-to-consumer genetic testing and the need for genetic counseling. Finally, we will discuss the social, legal, and ethical issues surrounding genetic testing.

OS-29 Sweats Versus Suits: Is Telecommuting Right for You? Karen Blackburn, Medical Writer II, PharmaNet/i3, Livonia, MI; Jodi Pollock, Medical Writer II, PharmaNet/i3, Apex, NC

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Program Descriptions & Presenter Information Come and join our discussion on the emerging telecommuting trend in the pharmaceutical industry. After a lively debate on the pros and cons of a home-based work environment, we will present our research findings on the growing telecommuting movement, physical and psychological aspects to consider, and employer-employee points of view on working from home.

OS-30

Soft Skills: As Important as Technical Skills

Kelleen Flaherty, Assistant Professor, University of the Sciences in Philadelphia (Biomedical Writing Programs, Mayes College of Healthcare Business and Policy), Philadelphia, PA

In both the professional and academic environments, “soft skills,” as a discretely recognized set of attributes, are becoming more in demand. But what are they? Most people in the workforce are aware of (and possess–or think they do–to varying degrees) the nebulously-defined qualities that employers look for, such worth ethic, teamwork, and leadership. There is, however, little consensus from authority to authority as to what constitutes soft skills. This presentation will provide a comprehensive review of over a dozen soft skills that have been identified by a variety of authorities such as the government, employers, recruiters, business experts, and universities, with a focus on biomedical writing professionals.

OS-31 What Is Health Economics and Outcomes Research? A Primer for Medical Writers Caitlin Rothermel, MA, MPHc, MedLitera, Seattle, WA

Medical writers are increasingly asked to work with health economics and outcomes research (HEOR) information. HEOR consists of 2 areas: analyses that estimate the economic impact of a specific intervention, and outcomes research tools that assess the economic and/or quality-of-life value of an intervention. Many medical writers have the underlying skills required to incorporate HEOR concepts into their work, but need more background to do this comfortably. This session will provide participants with an introduction to health economics study design, commonly used outcomes research strategies, and will explore the present and future role of HEOR in traditional and nontraditional clinical trial designs.

OS-32 Writing, the Cherokee Syllabary, and the Nature of Language Richard A. Rhodes, Associate Professor of Linguistics, Assistant Dean in the College of Letters & Science Undergraduate Division, University of California, Berkeley, CA

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In the early 1800s, an illiterate Cherokee man named Sequoyah created an-85 symbol syllabary that by 1824 allowed most Cherokees to read and write in their own language. It is easy to forget what language is and how the nature of our writing system affects how we convey meaning. Why can language offer laser-beam precision on one hand and maddening vagueness on the other? Sequoyah’s work parallels the development of our own writing system. Understanding this development can help explain how our capacity for language and our writing system affect how we communicate and how we might improve our own writing.

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Falsifications and Retractions

Andrea Gwosdow PhD, Gwosdow Associates Science Consultants, Arlington MA; Kim Barrett PhD Dean of Graduate Studies University of California San Diego; Rebecca Lew, PhD, CMPP, Senior Medical Writer, ProScribe Medical Communications

Amid the striving for good publication practices, modern technologies offer greater opportunities for authors to contravene publication ethics. At the same time, external funding pressures, team science, and the accelerating internationalization of research all pose challenges for the integrity of the scientific literature. This session will review the common types of publication ethics transgressions and resulting retractions, and how publication misconduct differs around the world. Approaches to resolving these issues will be discussed along with the role of medical writers in ethical publishing. Bring your questions.

Open Sessions » SATURDAY, October 6 (see pages 22-24 for times) OS-34 Advice

Translating New Media Theories into Practical

Diego Bonilla, Ph.D., Professor, Communication Studies, California State University, Sacramento, CA

In this presentation, Dr Bonilla will describe how computers affect our professional and personal interactions. Touching on both our use of websites and computer-mediated communication, such as email, Skype, and texting, he will comment on what we do well and not-so-well with these technologies.

Issues may include how on-line communication affects our ability to negotiate, how these technologies affect task-related communication, and what applications they have for creating personal and work-related networks and communities.

Program Descriptions & Presenter Information OS-35 Current Ethical Issues from Three Perspectives: Pharmaceutical Director, Publisher, Freelance Writer Charmaine Cummings, PhD; Thomas M. Annesley, PhD, Professor of Pathology, Ann Arbor MI; Andrea Gwosdow PhD, Gwosdow Associates Science Consultants, Arlington MA; Bryan Simpson, PharmD, Medical/ Scientific Advisor for Bayer HealthCare

Egregious ethical issues abound in the medical writing and research industry. Each stakeholder in an ethical situation has a perspective and is bound by regulations and codes of ethics.

At this session, three professionals (the stakeholders) will discuss their perspective surrounding current situations. Find out what tools they would use to resolve the ethical situations encountered and learn more about the AMWA ethical decisionmaking model.

OS-36 eSubmissions: A Brave New World for the Medical Writer Jennifer Grodberg, PhD, RAC, Senior Director, Regulatory Affairs, Trius Therapeutics, Inc.; Antoinette Azevedo, President & CEO, e-SubmissionsSolutions.com, San Diego, CA; Gregory Cuppan, Owner, McCulley/Cuppan LLC, Salt Lake City, UT

In January 2010, the European Medicines Agency began mandating eSubmissions. The FDA is expected to follow this year.

This session will lead participants through the requirements as they bear on the medical writer and the new way of thinking about eSubmissions as opposed to paper submissions. The panelists will cover why medical writers need to start thinking now about how these requirements impact both them and the submitting companies. The panelists will be demonstrating best practices in authoring that flow through to the successful review by a regulatory authority. In addition to a demonstration, there will be a talk-show format for a Q&A with the workshop attendees.

OS-37 Strategies for Working Successfully With ESL Authors Noelle H. Demas, MS, Independent Medical Writing Consultant, Panorama MedWriters Group, Inc., San Diego, CA; Charles Bedord, Pharmaceutical Development, Cupertino, CA; Lee Seaman, Seaman Medical, Inc., Bellingham, WA; Mary N. Wessling, PhD ELS, Language Matters, Corralitos, CA

Today English is the lingua franca of the scientific and medical world. However, effective English writing can be challenging for researchers and authors with English as their second language (ESL). The panelists will discuss linguistic and cultural challeng-

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es of ESL editing and will suggest ways for you to get involved in this growing field.

OS-38

Medical Writing Certification: Where Are We Now?

Thomas Gegeny, MS, ELS, Team Lead & Senior Medical Writer, UBCEnvision Group, Bridgeport, CT; Marianne Mallia, ELS, Manager and Senior Medical Writer, Texas Heart Institute, Houston, TX

What are the core skills and knowledge areas required to work as a medical writer? How can this specialized information be tested? What value or support does a certification examination lend to the characterization, context, and credibility of our profession? AMWA has embarked on an exciting new venture – creating a certification examination for medical writers.

Come hear the latest updates from Certification Commission members about where we are in this journey, what lies ahead, and how you can be a part of this effort.

OS-39 Planning for Future Scenarios in Medical Product Development As part of its strategic planning process, the Drug Information Association (DIA) has been engaged in scenario planning to examine what the future might hold for drug discovery and development. The process will help predict the implications of various scenarios and future needs of professionals involved in the discovery, development, and life-cycle management of biopharmaceuticals and other medical products, including medical writers. This session, presented by DIA leadership, will provide an overview of the scenario planning process and will discuss preliminary findings of the process that are of relevance to medical writing professionals.

OS-40

It’s Not Magic: It’s My Profession

Becky Chase Fowler, MA, Senior Writer, Jhpiego, Baltimore, MD; Kelly Schrank, Senior Medical Editor, Med Communications, Memphis, TN; Catherine M. Wernette, PhD, ELS, Editor-Writer-Analyst, CMW Consulting LLC, Auburn, AL

At Kelly Schrank’s Using Checklists for More Efficient Editing roundtable last year, we had a lively discussion about the perception some of our clients seem to have that what editors do is “make things pretty” or work some kind of “magic.” Indeed, many of us have had clients say things to this effect—“Do your magic!” And while most of us felt there was no harm meant by such comments (and that they may even be intended as compliments), many felt that they masked a lack of appreciation and understanding about exactly what writers/editors do, as

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Program Descriptions & Presenter Information well as a wish to remain as uninvolved and unaccountable as possible. It may be that some clients don’t care and that they don’t need to know everything we do. In the end, however, the group felt that working with someone who does not view you as a professional—in possession of distinct knowledge, skills, and expertise—can lead to inefficiencies, unrealistic expectations, frustrations, and hard feelings for both parties. We also felt there were things that could be done to address the situation.

OS-41 Claims Crafting for the Dietary Supplement Industry: Do’s & Don’ts Kathleen Dunn, MPH, RD, Director, Scientific Affairs, Revo Biolabs, a division of Revo Global, Inc.; Heather S. Oliff, PhD Science Consulting Group LLC; Steven S. Spitz, JD

It only takes a few misplaced or missing words—in product labeling or advertising copy—to transform a dietary supplement into a misbranded drug. In this interactive session, you will learn how to recognize the often not-so-bright line that separates them, so you can write compliant product claims.

You’ll have an opportunity to put your new skill into practice with lively case studies. For medical writers interested in job opportunities in the dietary supplement industry, you’ll also learn how to break into this $60 billion business and why honing this one skill can provide a serious competitive advantage.

Workshops » THURSDAY, October 4 (see pages 16-18 for times) WS-01 [711]

Synergy of Style, Substance, and Audience (ADV)

Elliott Churchill, MS, MA, President, A World of Words, Atlanta, GA

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 problemsolving units. To register for this workshop, it is recommended that you have already taken Effective Paragraphing and Organizing the Medical Paper or have at least 5 years’ experience as the primary author or substantive editor of medical manuscripts. Approximate homework time: 6 hours.

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WS-02

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Advanced Writing (ADV) [706]

Marianne Mallia, ELS, Manager and Senior Medical Writer, Texas Heart Institute, Houston, TX

With a focus on writing as a cognitive, problem-solving process, the workshop leader will emphasize goals, writing strategies you can use to reach these goals, and methods for overcoming blocks to productive writing. Participants will also discuss the importance of rewriting and editing to the writing process.

The workshop will be a combination of lecture and discussion, but individual work will not be critiqued during the workshop.

To register for this workshop, it is recommended that you have at least 5 years’ experience in editing or writing. Approximate homework time: 2-3 hours.

WS-03 Outlining for Writers and Editors (ES/EW/FL) [2007] same as WS-20 Sue Hudson, Senior Medical Writer, Medical Writing Associates, Simi Valley, CA

This workshop is designed for intermediate-level writers and editors. Participants will learn to use outlining for writing and editing medical texts. Topics will include the “what, why, and how” of formal outlining and its usefulness in gaining consensus on planned content, overcoming mental blocks, and reorganizing drafts. [Also offered on Friday morning as WS 20] Approximate homework time: 2-3 hours.

WS-04 Effectively Searching Online Databases (ES/EW/ FL) [2004] Thomas P. Gegeny, MS, ELS, Team Lead and Senior Medical Writer, UBC Envision Group, Southport, CT

This slide lecture and live Internet demonstration are intended for moderately experienced to more advanced Web users. The workshop leader will focus on the use of online databases, demonstrating the effective use of PubMed and Gateway from the National Library of Medicine as true databases rather than “search engines.” In particular, emphasis will be placed on the use of advanced features such as the MeSH database and LinkOut 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 single term in the search box and hitting Go, then this class is for you. Approximate homework time: 2 hours.

Program Descriptions & Presenter Information WS-05 Business Ethics for Medical Communicators (B) [2511] NEW! Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach, VA

Andrea R. Gwosdow, PHD, President, Gwosdow Associates Science Consultants, Arlington, MA This workshop provides an overview of ethical considerations involving the business aspects of medical communication in different work settings, including both large and small organizations as well as sole proprietorships. 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 deisions, and present their results to the entire group through roll play. Approximate homework time: 2-3 hours.

Note: This workshop is required to complete a certificate for Business.

WS-06 Journal Submissions Other Than Research Articles (CP/EW) [3007] Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX

This workshop is intended mainly for novice through moderately experienced editors. Through a combination of lecture and group discussions, participants in this workshop will explore the basics of writing and editing journal submissions other than research articles. The workshop leader will discuss case reports, techniques papers, and letters to the editor. Review articles will also be discussed briefly. Content and organization will be emphasized. Approximate homework time: 3-4 hours.

WS-07

Writing and Editing NIH Grants (CP/EW/FL) [3022]

Karen Potvin Klein, MA, ELS, Associate Director, Office of Research, Wake Forest School of Medicine, Winston-Salem, NC

This lecture and group discussion will provide a thorough framework for both new and experienced medical editors to make the grant-preparation process less harried. NIH applications are the topic of this workshop. Writing and editing exercises to craft key portions of an application and samples of “winners” that were funded will be included. Private (eg, foundation) proposals will not be addressed in this workshop.

Approximate Homework Time: 2–3 Hours.

WS-08

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Making Effective Slides (CP/EW) [3008]

Ann L. Davis, MPH, Senior Medical Communication Scientist, BristolMyers Squibb, Princeton, NJ

This workshop is designed for beginners and those with some slide-making experience. Participants will work through the ground rules for writing and designing medical slides, critique examples of good and bad slides, touch on production concerns, and evaluate slides made from the homework. The workshop leader will not include instructions on using PowerPoint software. Approximate homework time: 2-3 hours.

WS-09 Developing Publications in Accordance with GPP2 Guidelines (CP) [3026] NEW! Kathryn J. Boorer, PHD, Medical Writing Senior Manager, Amgen Inc, Thousand Oaks, CA

This workshop is intended for novices and moderately experienced writers and editors. The leader will describe a collaborative and transparent process for developing company-sponsored publications based on the Good Publication Practice for Communicating Company Sponsored Medical Research: GPP2 Guidelines. Through a combination of lecture and group discussion, participants will learn how to develop a publication from initiation through to submission and how to deal with a number of controversial issues, including authorship, access to data, and conflicts of interest. Approximate homework time: 3 hours.

WS-10 Regulatory Aspects of the Drug Development Process (RR/PH) [4010] Aaron B. Bernstein, PhD, Director, Regulatory Planning, Hoffmann-La Roche Inc, Nutley, NJ

In this workshop, designed for novices in the pharmaceutical industry, participants will learn about and discuss the drug development process with special emphasis given to regulatory documentation. Discussion will include a summary of the US, European, and International Conference on Harmonisation (ICH) guidelines and regulations that govern drug approval. Approximate homework time: 3-4 hours.

WS-11 Reporting Correlation and Regression Analyses (RR/G/SG) [4011] Jane Neff Rollins,MSPH, Medical Writer/Professional Speaker, Arnell Communications, Montrose, CA

Workshop participants will learn how to interpret and report correlation and regression analyses. Most of the workshop will be devoted to correlation and simple linear regression analysis.

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Program Descriptions & Presenter Information Suitable for new and experienced medical writers and editors, the workshop approaches the topics conceptually, not mathematically. Approximate homework time: 3 hours.

WS-12 Interventional and Observational Research Design (RR/EW/PH/SG) [4007] Michael L. Jones, MS, Director, Medical Writing, TKL Research Inc, Rochelle Park, NJ; Mary H. Whitman, MS, PhD, Senior Director, Medical Affairs, Janssen Biotechnic Inc, Spring House, PA

This workshop, intended for beginning medical writers who are inexperienced in clinical research design, will cover research trial designs used in the two primary types of investigations conducted by pharmaceutical companies, interventional and observational trials. Basic study designs will be categorized, characterized, and contrasted. Examples from the medical literature will be used to offer insight into judging design strengths and shortcomings. Participants will critique prototypical studies.

(Previously titled Biomedical Research Design.) Approximate homework time: 3 hours.

WS-13 Introduction to the Cardiovascular System (SM/ SBS) [3515] Susan E. Aiello, DVM, ELS, Editor-in-Chief, The Merck Veterinary Manual, Merck & Co., Inc, Bluebell, PA

This workshop is designed for those without a science background. The workshop leader will present the basics of the structure and function (anatomy and physiology) of the cardiovascular system, including the heart, blood vessels, and the blood itself. Why is the circulation of blood so important?

How does the heart do its job? What is blood’s function, and what’s it made of? Additional topics include the electrocardiogram, blood pressure, and various common terms related to the cardiovascular system. Approximate homework time: 2-3 hours.

WS-15

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Usage: Choosing the Right Word for the Job (NC)

Stephen N. Palmer, PhD, ELS, Senior Scientific Medical Writer, Texas Heart Institute, Houston, TX

Designed for beginning and moderately experienced medical communicators, this workshop will focus largely on specific words that are commonly misused in the medical literature. We will discuss correct and incorrect applications of these words, as well as alternative words that may more accurately express an author’s intended meaning. Examples include “utilize” versus “use”, “demonstrate” versus “show”, and “chronic” versus “long-term”. The workshop is primarily in a lecture format, but time will be allotted for participants to raise their own questions about usage and to discuss usage issues about which there is not clear consensus.

WS-16 What’s in That Pill? Testing, Standards, Safety, and the US Pharmacopeia (NC) Stefan Schuber, PhD, ELS, Director, Scientific Reports, US Pharmacopeia, Rockville, MD

Does that tablet really contain 81 mg of aspirin? Is that antimalarial drug a counterfeit? This workshop explores US Pharmacopeial (USP) standards for determining the identity, purity, quality, and strength of the drugs we take. Sometimes viewed as a frustration for manufacturers, sometimes seen as a friend, USP always is viewed as an enemy of counterfeiters. Participants will review pharmacopeial aspects of drug regulation, innovator and generic drugs, adulteration and counterfeiting of drugs, and the basics of measurement science for these activities.

Workshops » FRIDAY, October 5 (see pages 19-21 for times)

WS-14 Basics of Human Anatomy and Physiology (SM/ EW/PH/SG) [3503]

WS-17

MaryAnn Foote, PhD, President, MA Foote Associates, Westlake Village, CA

WS-18 Computer Searching the Medical Literature (ADV) [707]

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.

Joan N. Nilson, Senior Administrator, Regulatory Compliance, UPMC Health Plan, Pittsburgh, PA

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This advanced workshop is designed for medical communicators who wish to investigate effective strategies for accessing online informational health resources. A team approach will be used to review online assignments in class. Discussion will focus on selection of appropriate databases and on optimal

Program Descriptions & Presenter Information searching techniques. Topics will also include selecting an online database vendor, Internet sources, and the continued development of online informational resources. Approximate homework time: 3 hours.

WS-19 Critical Appraisal for Writers and Editors of Biomedical Research Articles (ADV) [726] MaryAnn Foote, PhD, President, MA Foote Associates, Westlake Village, CA

This workshop is intended for advanced medical writers and editors who want to improve their skills in critically appraising medical research or to improve their ability to think critically. The presentation and discussions will evolve around 13 questions and related concerns about the justification, design, execution, analysis, and interpretation of medical research studies. The homework assignment consists of reading several abstracts and then asking questions raised by presence or absence of the information in the abstract. Approximate homework time: 3-4 hours.

WS-20 Outlining for Writers and Editors (ES/EW/FL) [2007] same as WS-3 Sue Hudson, Senior Medical Writer, Medical Writing Associates, Simi Valley, CA

This workshop is designed for intermediate-level writers and editors. Participants will learn to use outlining for writing and editing medical texts. Topics will include the “what, why, and how” of formal outlining and its usefulness in gaining consensus on planned content, overcoming mental blocks, and reorganizing drafts. [Also offered on Thursday afternoon as WS 3] Approximate homework time: 2-3 hours.

WS-21 [2005]

Elements of Medical Terminology (ES/G/SG)

Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX

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.

WS-22 Essential Ethics for Medical Communicators (ES) [2006] same as WS-77 Jill M. Shuman, MS , ELS, Instructor, Tufts University, Boston, MA

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The workshop leader will provide a basic overview of ethical considerations with a focus on the AMWA Code of Ethics. The workshop comprises a homework assignment, an interactive lecture, and a class exercise—all designed to address the variety of ethical situations that occur in medical communication. Participants will be divided into small groups to discuss the case studies submitted as homework assignments, name the ethical problem, identify the involved stakeholders and their perspectives, debate alternative decisions, and use role-playing to present to the entire group. This workshop is suitable for both entry-level and experienced medical communicators.

[Also offered on Saturday afternoon as WS 77] Approximate homework time: 3 hours. This workshop is required to complete an Essential Skills certificate; 2 sessions are being offered.

WS-23 Fundamentals of Freelance Business Marketing (B) [2510] Brian Bass, President, Bass Global, Inc., Robbinsville, NJ

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 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.

WS-24 Writing Abstracts (CP/EW/PH) [3019] Thomas Annesley, PhD, Professor, University of Michigan Medical School, Ann Arbor, MI

This workshop is intended for medical editors and writers with up to 5 years’ experience. The workshop leader will present an overview of the purpose and structure of the medical or scientific abstract, with emphasis on abstracts prepared for publications. Registrants will evaluate and write abstracts using homework materials and workshop exercises. Approximate homework time: 1-2 hours.

WS-25 Plain Language (CP/EW) [3011] Sharon L. Nancekivell, MA, Freelance Medical Editor, Guelph, ON

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

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Program Descriptions & Presenter Information 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.

WS-26 Summarizing Clinical Efficacy Data for a New Drug Application (RR) [4013] Marijke H. Adams, PharmD, PhD, President, MH Adams & Associates, Inc, Davie, FL; Peggy Boe, RN, Medical Writer, Medical Writer, RPS, Inc, Hampstead, NC, Hampstead, NC

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 Efficacy Analysis (ISE) vs the Module 2.7.3 Summary of Clinical Efficacy.

Associated regulations and guidelines will be discussed, as well as the source documents and other tools needed for generating these documents. Approximate homework time: 2-3 hours.

WS-27 Writing a Protocol in Compliance With the International Conference on Harmonisation Guidelines (RR) [4018] Paula Fischthal, MA, Senior Medical Writer II, MedImmune Inc, Gaitherburg, MD

Learn to write a protocol for a clinical trial that is compliant with the International Conference on Harmonisation (ICH). The workshop leader will not only teach the regulatory requirements, but also show participants how the use of templates can shorten protocol development time. Participants will learn how to gather information, manage the review process, and understand who will be using the protocol. Approximate homework time: 3 hours.

WS-28 Canceled WS-29 Communicating Results of Routine Clinical Laboratory Tests (SM/EW/PH/SDT) [3506] Rita C. Tomlin, MT, MA, Owner and Manager, Tomlin Consulting LLC, San Diego, CA

The workshop is appropriate for inexperienced to moderately experienced writers. The workshop leader will cover basic

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concepts pertaining to laboratory terminology, including the components of a complete blood count and serum chemistry profile and their relationship to organ systems, with the goal of clear and concise communication of laboratory findings.

Reviewing laboratory summary tables and data listings, as well as correlating test results to adverse events for summaries in regulatory documents, are also covered. Although application in regulatory writing will be emphasized, the concepts covered are also applicable to journal articles and other forms of medical writing. Approximate homework time: 3 hours.

WS-30

Introduction to Basic Virology (SM) [3510]

Thomas P. Gegeny, MS, ELS, Team Lead and Senior Medical Writer, UBC Envision Group, Southport, CT; Rebecca Jarvis Beck, PhD, Senior Medical Writer, UBC Envision Group, Southport, CT

This workshop is intended for medical writers and editors with some biological background who want to improve their understanding of basic principles around the morphology, replication, and transmission of viruses. Previous background or some coursework in basic cell biology or molecular biology will be useful. The workshop leaders will review basic virus classifications, as well as several representative viruses that relate to clinical disease states, then focus on diagnostic tests used to identify viruses; antiviral therapies (vaccines vs antiviral medications); and mechanisms of viral resistance. Additional topics will include basic virus-host interactions, including key immune responses, principles around immune evasion, and oncogenic viruses in people. This workshop is appropriate for those who write for the public as well as those who write for medical and scientific readers. Approximate homework time: 2-3 hours.

WS-31

Basic Immunology (SM/SBS) [3501]

Michael A. Petrarca, PhD, Senior Medical Writer, PharmaNet-i3, Los Angeles, CA

Immunology is the study of mechanisms that defend the body against microorganisms, remove foreign material, and maintain body integrity. Advances in our understanding of immunologic mechanisms have produced extraordinary health benefits, such as immunization against disease and successful organ transplantation. On the other hand, immune reactions can produce pathological changes resulting in allergy, autoimmune diseases, and rejection of tissue and organ transplants. The workshop leader will present basic concepts in immunology; the workshop is intended for medical communicators with little or no background in this area. Approximate homework time: 3 hours.

Program Descriptions & Presenter Information WS-32 Medical Writing for Instructionally Sound, Engaging e-Learning (NC) Michelle Nolin Flewell, CPLP, Senior Director, Strategy and Solutions, Informa Training Partners, Walpole, MA

This workshop is suitable for beginner writers (or moderately experienced medical writers who are new to e-Learning) who write or seek to write e-Learning courses for workplace training. The workshop will feature lecture/presentation and live demonstrations of e-Learning courses with medical content and of e-Learning authoring tools and software. The workshop leader will introduce the participant to e-Learning and mLearning and discuss the value of e-Learning as an effective methodology for training adults in the workplace. The workshop will include a discussion and live demonstration of the specific attributes and benefits of instructionally sound e-Learning. The leader will also cover the development process, outputs, and various deliverables for e-Learning, and the role of the medical writer on e-Learning projects. Participants will learn the elements of a typical e-Learning storyboard (eg, screen content, audio narration), as well as specific strategies and techniques for writing engaging, interactive e-Learning content.

WS-33 Using Design to Improve the Readability of Medical Documents (NC) Lyn F. Gattis, PhD, Associate Professor, Department of English, Missouri State University, Springfield, MO

In this combined lecture/discussion format, participants without formal design training will learn basic principles of effective document design. The workshop leader will emphasize using design to make medical documents readable and accessible, not attractive per se. The presentation will focus on 4 principles of visual perception—contrast, alignment, repetition, and proximity—with applications ranging from the whole document to individual characters. The discussion will include data displays such as charts and tables.

WS-34

Navigating Public Health Information Online (NC)

Susan Lan, DO, MPH, Lan Medical Consulting, Edwards, CO

This workshop is for the beginner or moderately advanced medical writer and will be presented in a combination lecture and discussion format. The lecture will start with a discussion of the online Public Health infrastructure and organization. We will progress to current Public Health issues and where to find relevant and credible information online. Different online sources of Public Health information will be identified along with the

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different types of information and the best sources for various types of information. We will discuss how to distinguish between unbiased, commercial messages and advocate’s information.

WS-35 Strategies for Improving Document Quality for Pharmaceutical Communication Managers (ADV) [722] Art Gertel, Vice President, Strategic Regulatory Consulting, Medical Writing and Quality Assurance, Beardsworth Consulting Group Inc, Flemington, NJ

Improving the process of document preparation is crucial for medical writers. Discussion will include mechanisms for enhancing quality and accountability and for ensuring adequate time allowances. These are organizational issues around which a medical writing group can build policies aimed at ensuring a higher degree of accountability among those with whom they work and upon whose input they depend. This workshop is suggested for experienced medical writers who either are in a supervisory role or will soon be taking on that responsibility.

Approximate homework time: 2 hours.

WS-36

Canceled

WS-37

Basic Grammar I (ES/G) [2000] same as WS-55

Jude Richard, ELS, Senior Regulatory Writer, Synchrogenix Information Strategies Inc.; Chrissie Worth, MA, ELS, Freelance Editor, Calgary, AB

Thorough knowledge of parts of speech is truly basic to good writing and editing. This workshop focuses 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. [Also offered on Saturday morning as WS 55] Approximate homework time: 2 hours.

WS-38 Sentence Structure and Patterns (ES/G) [2009] same as WS-57 Flo Witte, PhD, ELS, Owner, Bluegrass Editorial Services Team LLC, Winchester, KY

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. [Also offered on Saturday morning as WS 57] Approximate homework time: 2-5 hours.

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Program Descriptions & Presenter Information WS-39 Punctuation for Clarity and Style (ES/G) [2008] same as WS-79 Helen E. Hodgson, PhD, Professor, Westminster College, Salt Lake City, UT

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. [Also offered on Saturday afternoon as WS 79] Approximate homework time: 2 hours.

WS-40

Tables and Graphs (ES/G) [2011] same as WS-76

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

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. [Also offered on Saturday afternoon as WS 76] Approximate homework time: 3 hours.

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to give a 5- to 10-minute presentation during the workshop; time permitting, all participants will be called upon to give their presentations. Approximate homework time: 2 hours.

WS-43

Organizing the Medical Paper (CP/EW/FL) [3010]

Faith Reidenbach, ELS, CMPP, Principal, Caley-Reidenbach Consulting LLP, Corvallis, OR; Janice M. Sabatine, PhD, CSC, President, Avanti Strategies LLC, Cranberry Township, PA

This basic workshop is designed for authors, authors’ editors, and journal editors. The workshop leader will focus on the principles of organizing and preparing original research reports for publication. Lecture, discussion, and exercises will be used to help participants analyze the function and content of each section of a medical paper. Approximate homework time: 2-3 hours.

WS-44 Preparing CME Materials: Concepts, Strategies, and Ethical Issues (CP/EW/FL) [3012] Marcello A. Morgan, MD, CCMEP, Senior Medical Director, ASiM, Somerville, NJ; Eve J. Wilson, PhD, ELS, CME Consultant and Freelance Medical Writer/Editor, Bowie, MD

The workshop leader will provide an overview of various types of pharmaceutical advertising and promotion, including print, television, direct mail, sales aids, and the Internet.

The workshop will then become a “war room” as participants immerse themselves in the creative process to formulate a brand personality, advertising platform, and creative strategy.

Approximate homework time: 2-3 hours.

Beginning to advanced medical writers are often involved in the preparation of educational-needs assessments, learning objectives, and content for continuing medical education (CME) activities. Writers need to have a working knowledge of how and why CME is developed, the main stakeholders in the process, and the roles of sponsors and supporters. In view of the ethical issues that may arise with the increasing role of pharmaceutical companies in providing CME grant support, writers need to be familiar with the guidelines set by the American Council on Continuing Medical Education, the American Medical Association, and other organizations. These important topics will be conveyed through lecture, practical examples, case studies, and discussion. Approximate homework time: 3 hours.

WS-42 [2505]

WS-45 Using Classical Rhetoric Principles to Enhance Medical Writing (CP) [3025]

WS-41 Creative Process in Pharmaceutical Advertising and Promotion (B/PH/PRAM) [2501] Brian Bass, President, Bass Global, Inc., Robbinsville, NJ

Making Effective Presentations (B/ED//PRAM)

Stephanie Roberson Barnard, Communication Consultant, Listen Write Present LLC, Wilson, NC

Lori L. Alexander, MTPW, ELS, President, Editorial RX inc, Orange Park, FL

Through lecture and discussion, participants will learn to select appropriate media and instructional materials, determine audience needs, and focus content for maximum impact. An introduction to the use of PowerPoint for developing presentations will be included. The workshop is appropriate both for novices and for those with some experience. Please come prepared

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 understand how persuasive tools are essential for meeting the needs of readers within a variety of medical writing

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Program Descriptions & Presenter Information contexts. Hands-on exercises will help participants learn how to apply rhetorical and persuasive techniques to documents for lay audiences. Medical journal articles are not a focus of this workshop. Approximate homework time: 3 hours.

WS-46

Writing for Video (CP/EW/PRAM) [3023]

Nick Sidorovich, MSEd, President, Rolling Hill Media LLC, Chatham, NJ

The workshop leader will focus on writing for video/CD-ROM, an increasingly popular tool for medical education. Writing for this medium requires simultaneous use of the left brain and right brain; writers have to get their point across verbally and visually to hold viewers’ attention. Guidelines will be provided on how to create effective presentations: conceptual development, scriptwriting style, production commands, and some of the special interactive features of CD-ROMs. Approximate homework time: 2 hours.

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writer’s contribution to the quality of an electronic submission.

Requirements and available online sources will be included.

Approximate homework time: 3-4 hours.

WS-49 [3504]

Basics of Molecular Biology (SM/EW/PH/SG)

Dominic De Bellis, PhD, Associate Director, Medical Writing, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT; Hilary Graham, MA, Coordinator of Department Publications, Department of Molecular Carcinogenesis, UT MD Anderson Cancer Center, Smithville, TX

Aimed at beginning and moderately experienced science editors and writers, the lecture and discussion of this workshop will help participants understand basic molecular biology concepts about DNA, RNA, and protein structure. Key terms and commonly used techniques will be reviewed, as will useful writers’ resources. Approximate homework time: 3 hours.

WS-47 Assessing and Communicating the Benefits and Risks of Medicine (RR) [4021] NEW!

WS-50 Evidence-Based Medicine for Medical Communicators (SM) [3509]

Lawrence E. Liberti, RPh, RAC, Executive Director, CIRS-Centre for Innovation in Regulatory Science, Holland, PA

Tamara Ball, MD, Principal Medical Writer, PharmaNet-i3, Ashville, NC

We balance benefits and risks for every activity in daily life.

Regulators, drug developers, clinicians, patients, payers and other stakeholders attempt to apply benefit-risk (BR) assessments to medicines. Despite intuitive approaches, the formal evaluation of a medicine’s BR is a relatively new, continually emerging science. A common framework for assessing and communicating BR is quickly approaching. This course is designed to introduce participants to the concepts that underlie techniques to assess the BR of medicines and to apply this knowledge to ways writers can approach more effective BR communications with stakeholders. Approximate homework time: 2 hours.

WS-48 [4008]

Investigational New Drug Applications (RR/PH)

Jennifer A. Fissekis, MA, ELS, Freelance Editor/Medical Writer, Rye Brook, NY and San Diego, CA; Jennifer Grodberg, PhD, RAC, Senior Director, Regulatory Affairs, Trius Therapeutics, INC, San Diego, CA

This workshop is intended for writers with little or no experience in preparing documents for regulatory applications. The leaders will cover the essential components of an investigational new drug application, FDA regulations, and the reviewer’s needs. Participants will also gain an understanding of the

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 related to the EBM movement. The workshop will be taught through an informal lecture format with a grouplearning activity and plenty of time for discussion. Topics will include what EBM is, the context in which it developed, how it is practiced, tools of EBM, study design, levels of evidence, bias, and the standards movement. Statistics associated with EBM will not be covered in depth. Approximate homework time: 2-3 hours.

WS-51 Approach to Writing Effective Standard Operating Procedures (NC) Nicola Bond, MBA, Senior Manager, Research Operations, Amgen Inc, Thousand Oaks, CA

This workshop is intended for moderately experienced to experienced medical writers who have little or no previous experience writing standard operating procedures (SOPs) or for those who want to expand their skill set to make themselves more marketable by learning to write a different type of document. This workshop will provide an introduction to the SOP document, and work through the process of creating an

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Program Descriptions & Presenter Information effective SOP from planning, setting standards, and choosing a document management system, to writing, implementing, and maintaining an SOP. Participants will examine a sample SOP and then write their own SOP, based on information provided.

WS-52 Writing Clinical Evaluation Reports for Medical Devices (NC) Felicia R. Cochran, PhD, Principal Clinical Research Specialist, Medtronic, Minneapolis, MN

While the FDA extensively overhauls its submission process for medical devices, American companies are seeking regulatory approvals in Europe. However, there are major differences between the requirements and review processes leading to market approval for medical devices in the European Union compared to FDA. In particular, a clinical evaluation report is required for all European medical devices. The workshop leader will provide practical advice for gathering and reporting valid clinical evidence in compliance with the new European Directive 2007/47/EC. WS-53 Cyber Security Savvy for the Medical Writer - Is Your Head in the Cloud? (NC) NEW! Susan Bairnsfather, CEO, EPharmaTech, LLC, Shreveport, LA

This workshop, designed for those with moderate knowledge of computers, will inform participants about recent breaches to online accounts and the need to get up-to-speed on methods to minimize these breaches of employer or client confidential data. The relative security risks of today’s common business tools, such as wireless devices and internet tools, will be discussed, as well as methods and practices to mitigate these risks to confidential information. Various technical terms will be introduced and explained.

Workshops » SATURDAY, October 6 (see pages 22-24 for times) WS-54 [732]

Taxonomic Analysis of Medical Writing (ADV)

Michael Schneir, PhD, Professor, Biomedical Sciences, Herman Ostrow School of Dentistry of USC, Los Angeles, CA

This participant-centered workshop is designed to cover a wide range of medical writing. In a highly congenial setting, participants will receive feedback on their previously submitted sample (about 100 words) of their best medical writing or

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copyediting. During a small-group tutorial (10 participants), participants, including the workshop leader, will identify and suggest revisions to distractions (disruptions of cognition, professional tone, harmony, and concision) at all textual levels of writing (but primarily syntactic and semantic). These distractions will be classified to facilitate their future recognition, analysis, and revision. This workshop is a combination of two previous workshops: #710 and #715. Participants who have received credit for completing either workshop #710 Semantic Analysis of Medical Writing or #715 Syntactic Analysis of Medical Writing cannot receive credit for this workshop.

Participants should check their curriculum record before signing up for this workshop. Approximate homework time: 3 hours.

WS-55

Basic Grammar I (ES/G) [2000] same as WS-37

Jude Richard, ELS, Senior Regulatory Writer, Synchrogenix Information Strategies Inc.

Chrissie Worth, MA, ELS, Freelance Editor, Calgary, AB Thorough knowledge of parts of speech is truly basic to good writing and editing. This workshop focuses 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. [Also offered on Friday afternoon as WS 37] Approximate homework time: 2 hours.

WS-56

Canceled

WS-57 Sentence Structure and Patterns (ES/G) [2009] same as WS-38 Douglas Haneline, PhD, Professor of English, Ferris State University, Big Rapids, MI

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. [Also offered on Friday afternoon as WS 38] Approximate homework time: 2-5 hours.

Program Descriptions & Presenter Information WS-58

Basic Grammar II and Usage (ES/G) [2001]

Anne Marie Weber-Main, PhD, Assistant Professor, University of Minnesota, Minneapolis, MN

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 offering a review of additional grammatical topics and discussion of 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 and Usage 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.

WS-59

Coaching Skills for Leaders (B) [2512] NEW!

Janice M. Sabatine, PhD, CSC, President, Avanti Strategies LLC, Cranberry Township, PA

This workshop is appropriate for anyone in a supervisory, management, or executive position or someone expecting to take on such responsibilities. The coaching techniques learned in this workshop can also be used by those in a subordinate role to enhance communication with a supervisor and to better support their peers. Expertise and experience communicating medical and scientific information contribute to making a successful medical writer, but are often not sufficient for strong and effective leadership. One of the most effective leadership skills involves coaching others’ behaviors and thinking. In this hands-on workshop, participants will increase their selfawareness as a leader, learn about and practice 3 key coaching behaviors, learn how to apply knowledge of the neurological and physiological reactions of the brain to effective coaching behaviors, practice basic coaching skills, and design an action plan for continued development and practice. Approximate homework time: 2 hours.

WS-60 Introduction to the Medical Device Industry (B/PH) [2503]

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Topics will also include the major market segments; products and therapeutic indications; specific job opportunities in the regulatory, clinical, and marketing departments; and the types of projects that may be assigned to employees or vendors. The workshop is designed for anyone with an interest in medical devices. The goal is to provide the participant with an overview of the industry, job and freelance opportunities in medical device companies, and a streamlined version of the regulatory environments in which these companies function. Approximate homework time: 3 hours.

WS-61 Ethical Standards in Medical Publication (CP/EW/ PH) [3004] Cindy W. Hamilton, PharmD, ELS, Principal, Hamilton House, Virginia Beach, VA

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.

WS-62

Essentials of Copyediting (CP/EW) [3003]

Flo Witte, PhD, ELS, Owner, Bluegrass Editorial Services Team LLC, Winchester, KY

This workshop is intended for beginning copyeditors and the leader will focus on basic copyediting skills. Copyediting is the process in which a manuscript is prepared for publication by revisions that ensure clarity, accuracy, and consistency.

Participants will learn the elements, principles, and processes involved in copyediting for scientific and medical publications.

Specific exercises will enable participants to identify typical copy problems and compare various editorial choices. Approximate homework time: 3 hours.

Jim Hudson, Medical Writer, Medical Writing Associates, Simi Valley, CA; Scott C. Thompson, ELS, Senior Medical Writer, Medtronic Spinal and Biologicis, Memphis, TN

WS-63 Writing and Designing Materials for Patient Education (CP/EW/PRAM) [3021]

The workshop leaders will cover the medical device industry, opportunities for medical writers in the industry, and the US and global regulatory environments that govern medical devices.

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,

Sharon L. Nancekivell, MA, Freelance Medical Editor, Guelph, ON

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Program Descriptions & Presenter Information writing, design, production, and evaluation. Participants will critique sample booklets and review the homework. Approximate homework time: 2-3 hours.

WS-64 The Electronic Common Technical Document (RR/PH) [4004] Peggy Boe, RN, Medical Writer, RPS, Inc, Hampstead, NC

This workshop is appropriate for regulatory/medical writers who have minimal or moderate experience in preparing documents for a pharmaceutical eCTD (electronic common technical document) regulatory submission. The teaching style will be primarily lecture with an exercise and some opportunity for discussion. The workshop leader will focus on what writers need to know to support team efforts for preparing regulatory documents slated for investigational and new drug marketing applications. Topics for discussion will include associated regulations and guidelines, the structure and format of the eCTD, and best practices for writing the documents that constitute the submission. Approximate homework time: 1.5-3 hours.

WS-65 Fundamentals of Ethics and Practical Applications (RR) [4020] Art Gertel, Vice President, Strategic Regulatory Consulting, Medical Writing and Quality Assurance, Beardsworth Consulting Group Inc, Flemington, NJ

Ethical considerations associated with conducting clinical research will be explored in this workshop intended for medical writers, editors, and researchers with some experience reviewing, analyzing, and communicating data-regulated therapeutic development activities. The workshop will consist of short presentations on relevant ethical issues with respect to therapeutic (drug, device, vaccine) clinical trials, and group discussions on major ethical considerations of some case studies. Topics include the importance of ethics in good clinical practice (GCP), the informed consent process and the challenges that may arise in developing countries, the infrastructure of ethics committees, and data safety monitoring committees. Throughout, the workshop will focus on the central ethical issue in clinical study conduct: to ensure subject safety and well-being.

Approximate homework time: 2 hours. Note: This workshop is one of the two RR ethics workshops available to complete the ethics requirement for an RR certificate (see WS 82); only one RR ethics workshop is required.

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WS-66

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Basics of Epidemiology (RR/EW/PH/SG) [4001]

Jane Neff Rollins, MSPH, Medical Writer/Professional Speaker, Arnell Communications, Montrose, CA

Designed for experienced medical writers, this combination of lecture and group exercises is based on the principle that medical communicators have a key gatekeeper’s role in ensuring the correct interpretation of scientific findings. Participants will be provided with the ABCs of data interpretation according to basic epidemiological concepts and research techniques. The focus will be on the critical appraisal of reported medical findings and the application of epidemiological tenets to improve the participant’s writing. Measures of disease occurrence, research designs, and causality development will be discussed. The workshop leader will use examples from clinical medicine, public health, and pharmacoepidemiology. Approximate homework time: 3-4 hours.

WS-67

Drug Interactions (SM/EW/PH/SDT) [3508]

Gayle Nicholas Scott, PharmD, CMPP, Medical Writer, UBC-Envision Group, Southport, CT

Drug interactions can be beneficial as well as harmful. The workshop leader will address the hows and whys of drug interactions—good and bad, pharmacokinetic and pharmacodynamic mechanisms, basic explanations of key concepts of pharmacokinetics and pharmacodynamics, and the role of genetics in drug interactions (pharmacogenomics). This is introductory information intended for writers and editors with no formal training in drug interactions or pharmacokinetics.

Approximate homework time: 2 hours.

WS-68 [3512]

Introduction to Cancer Pharmacology (SM)

Sunil Patel, MS, Drug Safety Associate II, Onyx Pharmaceuticals, South San Francisco, CA

This workshop is intended for beginning and moderately experienced writers and editors who have a basic understanding of cell biology, and will be taught through a combination of lecture and discussion. The workshop leader will focus primarily on elucidating—in conceptual, high-level terms—the mechanisms of common cancer drugs on the market, examining how key differences between normal and malignant cells allow for targeted therapies. Background information including the history of discovery of each drug will be provided. This workshop assumes a basic understanding of the principles of cell biology (eg, cell cycle, DNA replication, signal transduction). It would

Program Descriptions & Presenter Information

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be helpful for participants to have taken Basic Cell Biology or the Introduction to Cancer Biology workshop. Approximate homework time: 2-3 hours.

WS-71 The Good Page: Basic Design and Typography for Writers and Editors (NC)

WS-69 Ethics in Communicating Science and Medicine (SM) [3524]

More than ornate frill, the design of a page can make your words sing or disappear: readability and legibility are at stake here. The rubrics for creating beautiful pages and beautiful lettering have been in the world for centuries, and they can help us clarify our message, whether in an email, grant proposal, protocol, resume cover letter, or journal submission. This workshop will be an introduction to page layout and typography that can inform your writing and editing. And if you already know the difference between Bembo and Garamond, there will still be hands-on exercises to challenge you.

Tamara Ball, MD, Principal Medical Writer, PharmaNet- i3, Ashville, NC; Kathy Spiegel, PhD, Regulatory Writing Senior Manager, Amgen Inc., Grass Lake, MI

This workshop provides an overview of ethical considerations for communicating medicine and science to patients, health care providers, and others. Research-and-regulatory issues and publication-related issues will not be addressed because they are the focus of other workshops. This workshop comprises a homework assignment, an interactive lecture, and a class exercise. Participants will be divided into small groups, each of which will be given one of the case studies submitted as part of the homework. Groups will be asked to name the ethical situation, identify the stakeholders and their perspectives, debate potential decisions, and present their results to the entire group through role-play. Approximate homework time: 2-3 hours.

(Note: This workshop is required to complete a certificate for Concepts in Science and Medicine.)

WS-70 Writing a Meaningful Informed Consent Document in Compliance with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) Guidelines (NC) NEW!

Barbara Kristaponis, Graphic Designer and Medical Grant Writer/Editor, New York, NY

WS-72

Macroediting (ADV) [713]

Elliott Churchill, MS, MA, President, A World of Words, Atlanta, GA

In this workshop for experienced editors, participants will analyze the content and organization of a complete manuscript as a precourse exercise. During the workshop, participants will compare their skills with those of other experienced editors by reviewing the exercise together and learning about the art of macroediting. To register for this workshop, it is recommended that you have already taken Effective Paragraphing, Writing Abstracts, Tables and Graphs, and Organizing the Medical Paper, or have at least 3 years’ experience in macroediting.

Approximate homework time: 3-5 hours.

Michelle Eby, PharmD, CCRP, Consumer Safety Officer, Food and Drug Administration, Silver Spring, MD; Paula Fischthal, MA, Senior Medical Writer II, MedImmune Inc, Gaitherburg, MD

WS-73

Current Trends in Drug Regulations (ADV) [728]

The focus of this workshop, intended for those with little experience, is to develop knowledge of the process to obtain and write the informed consent document. Participants will become familiar with the historical significance of informed consent, domestic and international regulatory requirements, and best practices. Document samples and relevant exercises will be provided to highlight important aspects of the informed consent as well to examine what constitutes actual risk/benefit provisions, coercive vocabulary, potential ambiguity, and exculpatory wording. The workshop also includes an overview of the merits and limitations of readability formulas, and the practical application of these scales by way of examples that contrast and compare the effective use of lay language.

Mounting pressure to reduce the cost of drugs, recent publicity surrounding NSAIDs NSAIDs (nonsteriod anti-inflammatory drugs) and cardiovascular risk, and the public demand for pharmaceutical companies to fully disclose clinical trial results are changing the regulatory landscape. In Europe, the ascension of 10 new member states into the European Union, implementation of the Clinical Trial Directive, and the approach of the remaining New Medicines Legislation require global companies to redesign many of their regulatory and drug development processes. This Advanced workshop is designed for experienced writers who are familiar with the regulatory aspects of drug development. The leader will provide an overview of these and other recent regulatory changes. Participants will discuss how they and their companies have been affected by these developments. Approximate homework time: 2 hours

Aaron B. Bernstein, PhD, Director, Regulatory Planning, Hoffmann-La Roche Inc, Nutley, NJ

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Program Descriptions & Presenter Information WS-74 Effective Paragraphing (ES/G) [2003] same as WS-75 Helen E. Hodgson, PhD, Professor, Westminster College, Salt Lake City, UT

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 the development of a systematic approach to analyzing and correcting text. Options for arranging paragraphs and using transitions will be demonstrated in this review workshop. [Also offered on Saturday afternoon as WS 75] Approximate homework time: 4 hours.

WS-75 Effective Paragraphing (ES/G) [2003] same as WS-74

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2012

lecture, and a class exercise—all designed to address the variety of ethical situations that occur in medical communication. Participants will be divided into small groups to discuss the case studies submitted as homework assignments, name the ethical problem, identify the involved stakeholders and their perspectives, debate alternative decisions, and use role-playing to present to the entire group. This workshop is suitable for both entry-level and experienced medical communicators.

[Also offered on Friday morning as WS 22 ] Approximate homework time: 3 hours. This workshop is required to complete an Essential Skills certificate; 2 sessions are being offered.

WS-78 Bibliographic Resources for Medical Communicators (ES/G) [2002]

Flo Witte, PhD, ELS, Owner, Bluegrass Editorial Services Team LLC, Winchester, KY

Joan N. Nilson, Senior Administrator, Regulatory Compliance, UPMC Health Plan, Pittsburgh, PA

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 the development of a systematic approach to analyzing and correcting text. Options for arranging paragraphs and using transitions will be demonstrated in this review workshop. [Also offered on Saturday afternoon as WS 74] Approximate homework time: 4 hours.

This introduction to bibliographic resources in the health sciences will enable participants to become “information literate.”

The primary focus will be on types of bibliographic literature and ways to find and access this information. PubMed and NLM Gateway searches will also be analyzed and discussed, as well as integration of database searching with online search engines. Approximate homework time: 3 hours.

WS-76

Tables and Graphs (ES/G) [2011] same as WS-40

Jennifer A. Fissekis, MA, ELS, Freelance Editor/Medical Writer, Rye Brook, NY and San Diego, CA; Mark D. Weiss, MA, MS, President, Apothaceutics International Inc, Congers, NY

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. [Also offered on Friday afternoon as WS 40] Approximate homework time: 3 hours.

WS-77 Essential Ethics for Medical Communicators (ES) [2006] same as WS-22 Charmaine Cummings, PhD, RN, CEO and Founder, CJ Cummings Consulting, LLC, Edgewater, MD

The workshop leader will provide a basic overview of ethical considerations with a focus on the AMWA Code of Ethics. The workshop comprises a homework assignment, an interactive

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WS-79 Punctuation for Clarity and Style (ES/G) [2008] same as WS-39 Susan E. Aiello, DVM, ELS, Editor-in-Chief, The Merck Veterinary Manual, Merck & Co., Inc, Bluebell, PA

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. [Also offered on Friday afternoon as WS 39] Approximate homework time: 2 hours.

WS-80 Medical Journalism: From Choosing A Topic Through Polishing the Piece (CP/EW/FL) [3009] Barbara Gastel, MD, MPH, Professor, Texas A&M University, College Station, TX

Intended mainly for newcomers to medical journalism, this workshop will explore through presentation and discussion the basics of writing articles on medical topics for magazines, newspapers, and other publications for general readers.

Program Descriptions & Presenter Information Aspects to be addressed will include choosing topics, gathering and evaluating information, and crafting and refining the piece.

Approximate homework time: 3-4 hours WS-81

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2012

experiences will be discussed. The impact of guidelines from the International Conference on Harmonisation (ICH) and their effect on the standard report structure will be discussed in detail. Approximate homework time: 4 hours.

Proofreading (CP/EW) [3013]

Hope J. Lafferty, AM, ELS, Chief Writer and Editor, Hope Lafferty Communications, Marfa, TX

WS-84 Clinical Study Report Writing: From Tables, Listings, and Graphs to Text (RR) [4019]

The workshop leaders of this introductory workshop will focus on the differences between proofreading and copyediting, the definition and limits of proofreading, and standard proofreading methods and procedures. Participants will learn what proofreaders need to know to do the job and how to determine what to correct, query, or ignore. Approximate homework time: 1-2 hours.

Lawrence Giraudi, MSc, Principal Regulatory Documentation Scientist, Hoffman-La Roche Limited, Mississauga, Ontario

WS-82 Ethics of Communicating Regulated Drug Development Activities (RR) [4006] Marijke H. Adams, PharmD, PhD, President, MH Adams & Associates, Inc, Davie, FL; Peggy Boe, RN, Medical Writer, RPS, Inc, Hampstead, NC, Hampstead, NC

This workshop provides an overview of ethical considerations for communicating regulated drug development activities to scientists, regulatory authorities, health care providers, and others. This workshop will not address science-and-medicine issues or publication-related issues because they are addressed in other workshops. Topics relevant to regulated drug development activities include ethics in clinical and nonclinical trials, conflicts of interest (eg, financial, scientific), authorship of regulated documents, data management and archiving, plagiarism, privileged information, and collaboration. This workshop comprises a homework assignment, an interactive lecture, and a class exercise. Approximate homework time: 2-3 hours.Note: This workshop is one of the two RR ethics workshops available to complete the ethics requirement for an RR certificate (see WS 65); only one RR ethics workshop is required.

WS-83 [4016]

Writing the Final Report of a Clinical Trial (RR/PH)

Lawrence E. Liberti, RPh, RAC, Executive Director, CIRS- Centre for Innovation in Regulatory Science, Holland, PA

This workshop is intended for novices and moderately experienced medical writers; the leaders will offer approaches to generating a clinical study report. The components of the report, issues of quality control, and common problems and situations will be reviewed. Within this framework, ideal and real-world

This workshop is intended for writers and editors in clinical research with basic to moderate experience in developing clinical study reports (CSRs). With a focus on practical guidelines and examples, the workshop will give you a sense of how best to summarize information from statistical tables, listings, and graphs (TLGs) for a CSR. Examples will include selected passages from the demographics, and the efficacy and safety sections of a CSR, along with the related TLGs to clearly demonstrate the link between text and TLG. Emphasis will be on presenting data in a clear and concise manner. Many participants may benefit from first taking the Writing the Final Report of a Clinical Trial workshop. Approximate homework time: 4 hours.

WS-85

Introduction to Cancer Biology (SM/SG) [3511]

Catherine Magill, PhD, President, Magilla Consulting, Palo Alto, CA

This workshop is intended for beginning and moderately experienced writers and editors who have a basic understanding of cell biology, and will be taught through a combination of lecture and discussion. The workshop leader will cover basic structural characteristics of normal and cancer cells, as well as the progression that normal cells must make to become malignant, including a variety of genetic alterations that confer malignancy.

Several therapeutic approaches will be touched upon from the perspective of what this information tells us about the underlying biology of malignancy. Key terms and commonly used techniques will be discussed, as will useful Web-based cancer information resources. This workshop assumes a basic understanding of the principles of cell biology (eg, DNA structure and function, protein synthesis); therefore it is recommended that participants have previously taken the Basics of Cell Biology workshop (or equivalent). Approximate homework time: 3-4 hours.

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Program Descriptions & Presenter Information WS-86 Pharmacokinetics in Clinical Practice (SM/EW/ PH/SDT) [3519] Bryan Simpson, PharmD, Medical/Scientific Advisor, Medical and Scientific Affairs, Bayer HealthCare Pharmaceuticals, Toronto, ON, Canada

WS-89

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Introduction to Pharmacoeconomics (NC) NEW!

Barbara Jaszewski, HonBSc, MBA, Head Regional Market Access Europe/Canada and EMEA, Bayer HealthCare Pharmaceuticals, Bayer Pharma AG, Berlin, Germany

This introductory workshop is designed for the writer or editor who has not had formal pharmacokinetics training. The workshop leaders will cover basic pharmacokinetics including the absorption, distribution, metabolism, and elimination of drugs.

Key terms and basic mathematical concepts will be explained in a primarily lecture format. Drug interactions, therapeutic drug monitoring, and pharmacogenetics, as related to pharmacokinetics, will also be discussed. The workshop will be conducted from the perspective of the clinical use of pharmacokinetics.

It is not intended for regulatory, industrial, or academic writers and will not address pharmacokinetics used to fulfill regulatory requirements. Approximate homework time: 3 hours.

To ensure product success in the market place, successful application of sound pharmacoeconomic principles is essential to the survival of every pharmaceutical company. Pharmacoeconomic studies also serve to guide optimal healthcare resource allocation, key in the face of ever-rising healthcare costs.

Work­­shop participants will be introduced to the fundamentals of pharmacoeconomics, the cost-benefit assessment (monetary, efficacy, quality of life, societal) of a pharmaceutical product. This interactive workshop is intended for medical writers and editors who have a basic knowledge of the pharmaceutical industry.

WS-87

A Medical Writer’s Role in the New Protocol Development Program at the National Institute of Allergy and Infectious Diseases.

From Bench Scientist to Medical Writer (NC)

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

This participatory workshop will help scientists and clinicians discover how to use their skills in a career as a medical writer.

The workshop leader will discuss tools for determining kinds of writing that are right for the participants. Participants will discuss how to apply skills to this new arena. The nuts and bolts of starting out will be explored, including how to develop contacts and resources, how to get clips, and how to find a job.

Although freelancing will not be the primary focus of the workshop, it will be addressed. Bring questions for open discussion.

WS-88 Write to Learn: Practical Strategies for Developing Continuing Education Content (NC) NEW! Alexandra Howson, PhD, CCMEP, Principal, Thistle Editorial, LLC, Snoqualmie, WA

This workshop is designed for writers who are interested in preparing materials for continuing education activities and are unfamiliar with the principles of adult learning. This foundational workshop provides a critical introduction to the contemporary context for education in the health professions, including continuing medical education, the core principles of and current controversies in adult learning theories, and the stages and styles of learning. Through group-based activities and discussion, this workshop will explore types of continuing education materials and strategies for developing content that facilitates adult learning.

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Poster Presentations

Vali S. Sevastita, Tracey J. Miller, Doreen G. Chaitt, Jerome F. Pierson

Evidence of Decreased Ghostwriting in a Series of Three Surveys of Medical Communicators Conducted Between 2005 and 2011.

Cindy W. Hamilton, PharmD, ELS, Adam Jacobs, PhD, MSc

Preparing High-Quality Serious Adverse Event Narratives for Clinical Study Reports.

Henry Li, Kim Hanna

Systematic review on the prevalence of ghostwriting: misleading, misguided, and mistaken ‘evidence’.

Serina Stretton, Sericka McGee

Utilizing Techniques Applied by College Writing Center Tutors in Medical Editor-Author Dialogue.

Misty Bailey

A Biotherapeutics Playbook J. Nicole Earnhardt, PhD, Gretchen E. Dean, MA

The Safety Risk Management Plan (RMP) Development and Global Implementation Mary Ellen Wojcik, MS, ELS, Edwin Shaart, MD, MEd

Byline Authorship: Results From a Survey of Medical Writers Jon Nilsen, Erica Rockabrand, Paul Feinstein, Lucy Hyatt, Larry Kovalick, Shawn Lee, Dikran Toroser, Geoff Smith