Newsletter 09202012

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The Indiana Chapter September 2012 Newsletter FROM THE PRESIDENT, AMWA INDIANA CHAPTER Dear Chapter Members, Welcome to a new year with AMWA! I sincerely thank Anne Wolka for leading our chapter, as president last year and in other roles in many previous years. You may recall the spectacular chapter conference she organized in 2010. This year my objective is to start a conversation about AMWA among our chapter members and Indiana‟s larger biomedical community. Please join in and let us hear your voice! I hope this conversation will help us get to know each other, learn what we want our chapter to be, and build enthusiasm for excellence in medical communication. What could we talk about? Our chapter How can we make our chapter itself (in contrast to AMWA at the national level) meaningful to you? To find out, I plan to call each of you within the next 2 months. Please share your ideas with me and tell me what you honestly think. If your interest in AMWA lies only at the national level, tell me that too. For example, would you benefit from chapterwide distribution of short professional biographies of each chapter member, from an online directory of our chapter‟s freelance writers, or from an informal workshop on some aspect of medical communication? Membership & Volunteers Barbara Lightfoot, our president-elect and membership & volunteer chair, will welcome our new members and ask exiting members how we can improve our chapter. Please tell her about any organization or individual that might benefit from AMWA membership. Kristin Bullok, our LinkedIn AMWA Indiana chapter subgroup manager, has been helping chapter members hold discussions online. Please let her know about ways she could use LinkedIn to benefit our chapter. AMWA, at both the national and local levels, exists only because of its volunteers. These people give, but also get. Working with colleagues to build our profession helps people in early or middle stages of their careers develop professional relationships, learn about their profession, develop leadership and technical skills, and gain visibility. People in late stages of their careers benefit from the satisfaction of setting goals and standards for the AMWA Indiana Chapter Newsletter September 2012

profession, of preparing the next generation to continue something that matters, and of leaving the profession they love better than they found it. It‟s easy to volunteer at the chapter level. Just tell me or any other chapter leader (see list at the end of this newsletter) what you want to do. Don‟t worry about whether you know enough to participate – you do! Become a committee member if you would like to devote at least 3 hours per month to our chapter. In brief, the education committee plans educational projects and an annual chapter conference; the program committee plans stimulating events that include presentations, informal workshops, and networking; the membership & volunteer committee acts as the chapter‟s human resources department; the newsletter committee reports information about AMWA, our chapter, and Indiana‟s biomedical community; and the marketing committee develops professional relationships among our chapter members and Indiana‟s biomedical community. If you are too busy for a committee role but can spare a few hours this year, choose from a list of individual tasks available from any chapter leader. That list will soon be available on our chapter website. Volunteering at the national level is easy, too. Just take a look at the „Call for Volunteers‟ page at AMWA‟s website (http://www.amwa.org/default.asp?id=560) for a list of opportunities, and submit your volunteer interest form by September 24. (You can find more information in the “Best Of” column later in the newsletter.) If you are interested in presenting a workshop, leading an open session, or presenting a poster at the 2013 AMWA annual conference in nearby Columbus, OH, tell Laura Oberthur Johnson, our education chair, so she can help you prepare. Outreach Laura Oberthur Johnson and Ellen Stoltzfus will speak to university students about careers in medical writing. Laura needs volunteers from the chapter to help with an integrated research project she designed to assess the medical communication needs of the Indiana biomedical community and to find the unmet needs that our chapter and its members can fill. Tara Polston, our marketing chair, is busy developing professional relationships between our chapter and that community. Events Brad Philbrick, our program chair, is planning an outreach event to explain to the community what AMWA and medical communication are and to learn from the community what its medical communication views and needs are. He is also planning 3 additional educational events designed to help chapter members get to know each other and become better communicators. As for the past 2 years, we will podcast these events on the Page 1 of 6


The Indiana Chapter chapter website for the benefit of those too distant or busy to attend. Local networking events are being planned by Esther Brooks Asplund for the Bloomington area, by Jennifer Wampler for the Evansville area, by David Bell for the Fort Wayne area, and by Daniela Ilijevski for the Munster area. Please let me know if you would like to plan an event for the Lafayette area.

Reports from 2012 Indiana/Ohio Valley Chapter AMWA Conference The 2012 Indiana/Ohio Valley Chapter AMWA Conference took place on May 4-5, 2012, at Conner Prairie Interactive History Park in Fisher, Indiana. The one-and-a-half-day event offered 35 registrants 2 credit workshops, 5 dinner roundtables, and 10 career enrichment open sessions.

Qing Zhou, our newsletter editor, will report these events as well as other information of interest to our members. Please let her know if you would like to see or submit an article or interview on some particular aspect of medical communication. Qing will also broadcast a monthly newsflash that advertises upcoming chapter events and summarizes AMWA news you might have missed.

Cindy Hamilton, PharmD, ELS, led the 2 workshops: “Creating Effective Poster Presentations” (CP/EW/PH) [3001] and “Essential Ethics for Medical Communicators” (ES) [2006]. Cindy is a past president of national AMWA, and in 2011, received the Golden Apple Award for consistent excellence in teaching in AMWA‟s educational program.

I am planning a simple chapter conference for next Spring in downtown Indianapolis. It will emphasize networking and educational open sessions, to help chapter members get to know one another. Please let me know if you would like to present an open session on one of your areas of expertise.

The 2012 Indiana/Ohio Valley Chapter AMWA Conference continued to offer career enrichment open sessions, which were introduced in the conference program 2 years ago and have since been well received by conference attendees. This year, 10 speakers presented on a variety of topics, ranging from AMWA educational opportunities to institutional review boards and contracting for medical writers. Podcasts and slides of these presentations will be available on the chapter website in early November (6 months from the conference date).

National AMWA The annual conference this year (October 4-6 in Sacramento, CA) will include 4 new events to help you get to know your colleagues continent-wide―a free (with registration) lunch, an afternoon speed networking session, an evening wine and cheese reception on Thursday, and a free lunch on Saturday. Our chapter members attending the conference will get together for dinner after the Thursday reception. Details about the dinner will be sent to conference registrants later this month.

In addition to open sessions, this year‟s chapter conference offered dinner roundtables, similar in format to the popular breakfast roundtables at the national AMWA conference. Participants enjoyed interactive discussions at 5 dinner roundtables held on the first day of the conference.

You may take up to 4 (a maximum of 3 for past conferences) of the 87 credit workshops offered at this conference and attend as many noncredit workshops and open session as you like.

Participants at the 2012 chapter conference.

AMWA is developing, and plans to offer within the next 3 years a certification test of medical writing skills that will in part be rooted in the Drug Information Association (DIA) model of competency in pharmaceutical medical writing proposed by David Clemow (of our chapter) and others.

(Photos provided by Anne Wolka.)

Here‟s to talking with you! David Caldwell 2012-2013 Indiana chapter president Tel: (317) 846-2183 Email: davidccaldwell@att.net

AMWA Indiana Chapter Newsletter September 2012

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The Indiana Chapter The conference organizers, Barbara O. Lightfoot and Laura Oberthur-Johnson, would like to thank the Workshop Leader (Cindy Hamilton), conference registrar (David Caldwell), attendees, open session presenters, dinner roundtable moderators, workshop monitor, Yvonne Todd, and the Conner Prairie staff, as well as MBP Distinctive Catering for making the 2012 Indiana/Ohio Valley Chapter AMWA Conference a great success! Qing Zhou, Newsletter Editor

Brief Notes from Open Sessions OS 01 AMWA Educational Opportunities Presenter: Barbara Snyder, MA (President, AMWA)  Options of AMWA‟s educational opportunities  Expanded certificate program  Additional educational resources OS 02 The DIA Medical Writing Competency Model Presenter: Michael Mihm, PhD What is the DIA Medical Writing Competency Model?  How can it be used?  Why do I care?! OS 03 Locating and Using Electronic Resources Presenter: Elaine Skopelja, MALS, AHIP  Locating electronic resources  Using electronic resources  Organizing your resources  Resource URLs OS 04 Medical Writing in the HEOR World Presenter: Kathy Oneacre, MA  Introduction to Health Economics and Outcomes Research  What we write: manuscripts, literature reviews, meta-analyses, dossiers  How we manage what we write OS 05 Health Writing Presenter: Kurt Ullman, RN, BSPA, MHA  Medical Writing: regulatory writing, scientific publications, professional-to-professional  Health Writing: closer to journalism, larger and much more heterogeneous audience, it informs people (Please see a more detailed summary provided by Nancy Pollack for this open session later in the newsletter.) OS 06 Know the Deal: Understanding and Navigating Common Contract Terms and Issues Presenter: Brad Maurer, JD  Enforceability  Addressing disputes AMWA Indiana Chapter Newsletter September 2012

   

Calculating damages Other remedies Statutes of limitations and repose Alternative dispute resolution

(Please see a more detailed summary provided by Brad Philbrick for this open session later in the newsletter.) OS 07 From QUOROM to PRISMA: How Medical Writers Can Improve the Reporting of Systematic Reviews and MetaAnalyses Presenter: Barbara Lightfoot, BS, CCRP  Systematic review and meta-analysis defined  Importance of systematic reviews and metaanalyses  From QUOROM to PRISMA: history of PRISMA Statement development  Discussion of PRISMA components: 27-item checklist and flow diagram  Inclusion of PRISMA in Instructions to Authors: examples of journals that require the use of PRISMA OS 08 Editing for the Medical Writer Presenter: Rod Everhart, BA, ELS  What does a medical editor do?  Skill set  Relationship between editor and medical writer  Future direction of medical editing/communication  Sample editing test OS 09 Medical Writing and Applications to Human Subjects Institutional Review Boards Presenter: Gretchen Parker, PhD, RAC  Introduction and history  The role and responsibilities of institutional review boards (IRBs)  Major areas that must be addressed in an IRB submission  Common mistakes made in writing a research application submission to an IRB OS 10 Regulatory Issues in Medical Device Development Presenter: Barbara Lightfoot, BS, CCRP  Device classes  Identification of: 510(K) premarket notification, predicate device, Investigational device exemption, premarket approval  Global perspectives for device approval o United States o European Union o China o Russia Podcasts and slides of these presentations will be available on the chapter website in early November, 6 months from the conference date. Page 3 of 6


The Indiana Chapter Open Session Summaries Health Communications (OS 05) Speaker: Kurt Ullman, RN, BSPA, NHA By Nancy S. Pollack Our AMWA organization calls us medical writers, but Kurt Ullman made a distinction between medical writers and health writers in his presentation on Health Communications. A registered nurse with a master‟s degree in Health Administration, Kurt is the owner of Medical Communicators and provides writing services to magazines, websites, and CME providers. He has written over 500 articles, many on health-related topics, for both professional and consumer audiences. Clients have included The Rheumatologist magazine, Health Behavior News Service, VersusMed, and WebMD. He has also written a weekly newspaper column for syndication by the Indiana University Medical Center and Best Practice Guidelines for a hospital chain in the Midwest, and worked for 6 years as a staff writer and editor in radio, television, magazines, and newspapers. Medical writing vs health writing Kurt explained that the major differences between the 2 types of writing are based on their audience and their function. He pointed out that medical writing (eg, regulatory, professional-to-professional) is targeted, functional, and imparts knowledge, whereas health writing is closer to journalism, targets a more heterogeneous audience, and imparts information. Medical writing: More focused Imparts scientific knowledge Mainly regulatory or professional audiences Tightly formatted Legal, structured voice Team-oriented More likely to be work for hire

Health writing: More eclectic Gives information Varied audiences Variation in formats Conversational voice Smaller teams and more single writers More variability in copyright ownership

What does a health writer do? Kurt gave examples of the types of writing a health writer could be hired to produce:  Health information (awareness, websites, diseases, patient handouts)  Health education (patient care, treatment options, new procedures)  Decision support (treatment choices, outcomes); often this would be more technical AMWA Indiana Chapter Newsletter September 2012

Marketing (for example, to differentiate one medical practice from another)

Some examples of health writing for magazines Service line magazines. An example of this would be a hospital promoting their services or patient satisfaction to primary care physicians to generate referrals  Mostly for referral physicians in the community  Marketing tool Community magazines  Audience is potential patients from the area  Focuses on what the hospital does best or wants to push  More focused on features than news-oriented General magazines  May talk about specific disease or group of diseases  May have a wider spectrum of story interest, including nonmedical stories  Approach by the writer is much different Contracting for Medical Writers―Know the Deal: Understanding and Navigating Common Contract Terms and Issues (OS 06) Presenter: Brad Maurer, JD, Faegre Baker Daniels, LLP By Brad Philbrick Brad Maurer launched his session by stating that in its simplest form, when there is an offer plus acceptance, one has a contract. A good contract is one that will serve and protect both parties amicably. Brad listed fundamental contract issues that should be included in an agreement, which are:  Enforceability  Addressing disputes  Calculating damages  Other remedies  Statutes of limitations and repose  Alternative dispute resolution Most time of the talk was spent discussing enforceability. Several requirements are necessary in a contract to ensure enforceability. One such requisite is mutuality of obligation: both parties must be bound to perform their obligations or the law will treat the agreement as if neither party is bound or obligated to perform. When an offeree and offeror exchange promises to perform, one individual or group may not be given the complete and sole right to cancel a contract. Reasonable Certainty of Essential Terms implies that terms and conditions that you use should be tailored to the needs of your business. A good contract would include the delivery details: who delivers, when, and where. Priceand-payment structure is a very important essential term. Other essential term items would include confidentiality Page 4 of 6


The Indiana Chapter provisions, a description of services performed, rights of a party to terminate a contract, and finally which state or perhaps a country‟s laws apply to the contract. The statute of frauds gives reference that some contracts must be signed in order to have a valid document. These contracts are typically tied to a monetary amount, a period of time, or expectations of performance. Brad made a strong statement when saying to us, “If you are only going away with one point, get this: what is the essence of the agreement?” It is important to both parties to know what they expect, what the obligations are, and how the met obligations are to be satisfied. The one point no party wants to face … calculating damages. Damages are measured in 3 different ways. Expectation damages are what can be recovered from a breach of contract by the nonbreaching party. Expectation damages are not punitive; its purpose is to place the nonbreaching party in the position that they would have occupied had the contract been fulfilled. In short, it would be money a medical writer expected to earn for their work. Reliance damages are the measure of compensation given to a person who suffered an economic harm for acting in reliance on a party who failed to fulfill their obligations. It is the amount of money a medical writer spent to make a “work”, that is their expenses. In reliance damages the aggrieved party cannot be put in a better position had the contract been performed. Restitution damages restore the benefit conferred to the nonbreaching party. It is the return of the “work”. In short, always keep in mind 2 important aspects of a contract. First, what is the heart of the agreement – what are obligations of each party and what gains is each expecting? The second important point is the ability to enforce the agreement. Make sure the contract states means to measure and clearly makes obligatory what is to be provided when obligations of each party have been served. Of course, it is a good idea to obtain legal counsel when embarking on any important project.

The Best Of: Highlights of Local and National AWMA News ♦ Becoming an AMWA workshop leader: Sharon Nancekivell (administrator of AMWA‟s Education Committee; sharon.nancekivell@sympatico.ca) is actively recruiting credit workshop leaders and co-leaders. Susan Krug (executive director) will soon distribute a request for volunteers.

to Sharon, who will take your request to the Education Committee for approval. If you propose to start a new credit workshop, you may be asked to first teach your subject a few times as a noncredit workshop or breakfast roundtable. If your students like your presentation, the committee will approve your new credit workshop. Sharon said that she understands the frustration felt in the past by many who tried to volunteer but got no response. She said that problem has been corrected. The above information was provided by David Caldwell, our chapter‟s president and delegate to the 2012 Spring BOD Meeting. ♦ Free publication planning event: The 5th Annual Publication Planning Update meetings, run by ThePublicationPlan.com with support from Adis Journals, are free to attend for all publication planning professionals. Name of the event: Publication Planning Update - Access and openness - the evolving publications landscape The dates and locations: • 2 October 2012 in San Francisco • 4 October 2012 in New Jersey • 9 October 2012 in London This year, Liz Wager, Publications Consultant - Sideview, will once again review topical developments in the publication planning industry, while Amitabh Prakash, Editor of Clinical Pharmacokinetics, will provide an overview of open access and what to look for in making your OA journal selection, as well as insights about the meaning and value of publication metrics. In addition, a speaker from the ISMPP Sunshine Task Force will provide an update on the Sunshine Act and what this is currently expected to mean in practice. Publication Directors from Pharma will also provide insights from the industry perspective. In addition to formal presentations with Q&A, there will be interactive panel sessions using key pads to provide instant feedback and stimulate debate. There will also be the opportunity to network with both presenters and peers over a complimentary lunch. Please see full details at www.thepublicationplan.com/october2012.html

If you are interested, send your CV, what you want to be (leader or co-leader), and what subject you want to teach AMWA Indiana Chapter Newsletter September 2012

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The Indiana Chapter 2012-2013 AMWA Indiana Chapter Board: President: President-Elect: Secretary: Treasurer:

David Caldwell Barbara Lightfoot Ellen Stoltzfus Phadungchom (Pam) McClelland

davidccaldwell@att.net lightfoot_barbara_owens@lilly.com ellenstoltzfus@gmail.com mcclelland_phadungchom@lilly.com

Membership/Volunteer Chair: Program Chair: Program Committee:

Barbara Lightfoot

lightfoot_barbara_owens@lilly.com

Brad Philbrick David Bell, Julie Beyrer, Esther Brooks-Asplund, Daniela Ilijevski, Laura Oberthur Johnson, Ellen Stoltzfus, Jennifer Wampler Laura Oberthur Johnson Barbara Lightfoot, Ellen Stoltzfus Tara Polston Qing Zhou Svetlana (Lana) Dominguez, Ellen Stoltzfus Kristin Bullok Anne Wolka

sailwrite@sbcglobal.net

Education Chair: Education Committee: Marketing Chair: Newsletter Editor: Newsletter Committee: Social Media Manager: Past President:

Laura.OberthurJohnson@optum.com tark3@aol.com qzhou@medinst.com

bullok_kristin@lilly.com wolka_anne_marie@lilly.com

Contact any Board member with questions or ideas for the chapter.

About AMWA: The American Medical Writers Association (AMWA) is a national organization for writers, editors, and other professionals in medicine and science. The association was founded in 1940 and has regional chapters throughout the United States and Canada and members in 30 other countries throughout the world. Through an extensive educational program, various publications, and unparalleled opportunities for networking, AMWA encourages and enables its members to extend their professional expertise.

AMWA Indiana Chapter Newsletter September 2012

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