AMWA Carolinas Chapter 2016 Spring Conference Friday, May 6, 2016 7:45 AM to 6:00 PM The William & Ida Friday Center for Continuing Education 100 Friday Center Drive Chapel Hill, NC 27517

2016 SPRING CONFERENCE SCHEDULE THURSDAY DINNER 6:30–8:30 PM | FRIDAY CONFERENCE 7:45 AM – 5:00 PM Preconference Dinner (Thursday, May 5, 2016, 6:30–8:30 PM) Join us for a preconference dinner at the Tobacco Road Sports Café at 1118 Environ Way in Chapel Hill from 6:30 to 8:30 PM. Get to know fellow AMWA members in a relaxed environment before the conference begins. (The dinner will be held in a private room at the restaurant and participants are responsible for their own costs.) Tobacco Road offers a variety of entrée options and is conveniently located in East54 off NC Hwy 54 (less than a mile from the Friday Center). For restaurant information or directions, visit http://www.tobaccoroadsportscafe.com/location/chapelhill.html or call (919) 537-8404.

Conference Registration & Breakfast (Friday, May 6, 7:45–8:30 AM) Pick up your registration packet, network with colleagues, and enjoy a deluxe continental breakfast.

Morning Session AMWA WORKSHOP OPTIONS (8:30–11:30 AM) Basics of Epidemiology [RR/EW/PH/SG] [4001] Bart Harvey, MD, MSc, PhD, MEd, FRCPC, FACPM, MWC Serving Two Masters: Comparing and Contrasting US and EU Regulatory Processes [RR][4024] Art Gertel (Note: This workshop ends at noon)

OPEN SESSIONS 8:30–10:00 AM*

The Role of Medical Writing in Pharmacoeconomics and Outcomes Research Deirdre M. Mladsi and Shahnaz B. Khan, MPH

10:15–11:45 AM

Trends and Transformations in CME: Interpretations and Implications for Medical Writers and Editors Monique Johnson, MD, CHCP

*Please note, there will be a short break between sessions (from 10:00 to 10:15 AM) so that you can check messages, use the restroom, etc.

Lunch (11:45–1:00 PM) A buffet lunch is included with your registration. Some tables will have a topic to discuss to facilitate further learning and professional connections. Other tables will have open discussion. You may select a topic during registration. Newcomers Corner Leader: Ashley Godfrey, PhD, RAC Clinical Research Scientist, IMPACT Pharmaceutical Services How to Deal With a Grumpy Client Leader: Robin Whitsell, BPh President, Whitsell Innovations, Inc. The Importance of Soft Skills for Medical Writers Leader: Lori Rochelle, PhD Senior Medical Writer, Inventiv Health

Computer-Generated Models: Reporting Study Results Leader: September Mihaly, PhD, RAC Regulatory Writer, Synchrogenix Quality Control for Regulatory Submissions Leader: Suzy Lawton, RAC, CCRP Owner/Medical Writer, Lawton Clinical Project Management for Regulatory Medical Writers Leader: Nancy Gasper-Smith, PhD, RAC Senior Manager, Medical Writing and Submissions Management, IMPACT Pharmaceutical Services Writing and Editing Tools for Efficiency Nonregulatory Writing Opportunities Leader: Margaret Mathes Leader: Tom Burns, MS Medical Editor, RTI Health Solutions Principal, Tekrighter Scientific & Medical Writing Services AMWA Carolinas Spring Conference | May 6, 2016 | The Friday Center | Chapel Hill, NC 2

Afternoon Session AMWA WORKSHOP OPTIONS (1:15–4:15 PM) Essentials of Copyediting [CP/EW] [3003] Loretta Bohn Understanding Sample Size and Study Power [ADV] [729] Bart Harvey, MD, MSc, PhD, MEd, FRCPC, FACPM, MWC

OPEN SESSIONS 1:15–2:45 PM*

Evolution of Medical Communicators: From Puppets to Masters of Integrity Chantelle Rein-Smith, PhD, and Cindy W. Hamilton, PharmD, ELS

3:00–4:30 PM

How to Launch a Freelance Career Panelists: Eugene Casale, PhD, Caryl Schwartzbach, PhD, and Ursula Jorch, MSc, MEd

*Please note, there will be a short break between sessions (from 2:30 to 2:45pm) so that you can check messages, use the restroom, etc.

Social Hour (4:30–6:00 PM) Details to be announced in registration packet Take time to socialize with colleagues. Exchange ideas, trade business cards, and make plans to attend the next AMWA event. Take a breather after a full day of learning, and kick off your weekend feeling relaxed!

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2016 SPRING CONFERENCE

SUMMARY

Please register online. Payment can be made online at the time of registration or mailed in. See details in left column.

REGISTER EARLY! Registration is limited to the first 30 paid applicants for each workshop, and open sessions are limited to 35 registrants. Registration prices are listed for members (students and postdocs with ID can get the member prices) and nonmembers. You can get the member prices by joining AMWA before registering.

Registration Fee Required for all attendees; includes breakfast, lunch, and all open sessions. Member rates (the first amount listed on the left) include students & postdocs with ID. Nonmember rates are listed on the right. Registration on or before April 22, 2016 $100/$160 On-site registration after April 22, 2016 $110/$170

REGISTRATION DEADLINES If you want to participate in workshops, the registration deadline is April 15, 2016 (no exceptions). If you plan to attend only open sessions, the online registration deadline is April 22, 2016. After April 22, registration will be possible only on the day of the conference.

Morning Session When you register online, choose 1 workshop or 2 open sessions.

WORKSHOPS

Members/Nonmembers

If you register for AMWA credit workshops, a link to the homework will be on the registration receipt. Workshop homework is due by no later than April 15, 2016 (no exceptions).

Basics of Epidemiology [RR/EW/PH/SG] [4001] Serving Two Masters: Comparing and Contrasting US and EU Regulatory Processes [RR][4024]

CANCELLATION/REFUNDS

OPEN SESSIONS

You must email [email protected] to cancel registration and request a refund at least 3 weeks before the event (by April 15, 2016). Refunds will be issued through your method of payment, less a $25 registration cancellation fee and $35 per workshop cancellation fee. Conference registration is nonrefundable after April 15, 2016. No refunds or credits will be given for failure to attend, late arrival, unattended events, or early departure.

The Role of Medical Writing in Pharmacoeconomics and Outcomes Research Trends and Transformations in CME: Interpretations and Implications for Medical Writers and Editors

HOMEWORK DUE DATE

$125/$195 $125/$195

$0/$0

$0/$0

Afternoon Session When you register online, choose 1 workshop or 2 open sessions.

REGISTRATION FEES

WORKSHOPS

Registration is required for all attendees and includes breakfast, lunch, and all open sessions. Registration by April 22, 2016: AMWA members or students = $100; Nonmembers = $160 Onsite registration (check only): AMWA members or students = $110; Nonmembers = $170

Members/Nonmembers

Essentials of Copyediting [CP/EW] [3003] Understanding Sample Size and Study Power [ADV] [729]

$125/$195 $125/$195

OPEN SESSIONS Evolution of Medical Communicators: From Puppets to Masters of Integrity How to Launch a Freelance Career

PAYMENT INFORMATION & CONFERENCE QUESTIONS To register and pay online: Online registration and payment is available at http://www.amwa.org//calendar_day.asp?event=1576&date= 5/6/2016. An automatic email will be sent to confirm registration and provide a receipt. Registrations paid by check will not be processed until the check is received at AMWA headquarters and will be processed in the order in which they are received. If you have questions regarding your registration, please contact AMWA at [email protected] or by telephone at 240-238-0940, ext103. For program or other conference questions, please contact Jacqueline Powell, AMWA Carolinas Chapter President, at [email protected].

Social Hour

$0/$0 $0/$0 $0/$0

Other Fees (optional) AMWA annual membership dues (available at http://www.amwa.org/assoc_subscribe.asp) Certificate Enrollment (term is 6 years) Essential Skills, Composition and Publication, or Regulatory and Research (available at http://www.amwa.org/enrollment)

$180 $150/$275

When you register online, please also indicate whether or not you are planning to attend the preconference dinner.

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AMWA Workshop Descriptions BASICS OF EPIDEMIOLOGY [RR/EW/PH/SG] [4001] Designed for experienced medical writers, this combination of lecture and group exercises is based on the principle that medical communicators have a key gatekeeper’s role in ensuring the correct interpretation of scientific findings. Participants will be provided with the ABCs of data interpretation according to basic epidemiological concepts and research techniques. The focus will be on the critical appraisal of reported medical findings and the application of epidemiological tenets to improve the participant’s writing. Measures of disease occurrence, research designs, and causality development will be discussed. The workshop leader will use examples from clinical medicine, public health, and pharmacoepidemiology. Instructor: Bart Harvey, MD, MSc, PhD, MEd, FRCPC, FACPM, MWC Approximate homework time: 3 hours SERVING TWO MASTERS: COMPARING AND CONTRASTING US AND EU REGULATORY PROCESSES [RR] [4024] There is now an internationally agreed format for the presentation of an application dossier for a marketing authorization for a pharmaceutical product: The Common Technical Document (CTD). It is accepted by the three participating regulating authorities (USA, EU, and Japan) as well as by other “observer” parties (e.g. Canada). This does not mean, however that there is commonality in the processes required for submission and review, the content of dossiers, nor the way in which reviewers approach the assessment of the dossier. In particular, there are significant differences between the way data are summarized and the approach taken by European reviewers and that taken by their counterparts in the USA. While some of these differences may ultimately evolve to a state of commonality, others likely never will. Participants will be introduced to the legal origins and mandates, and will review some of the labyrinthine procedures associated with preparing, filing, and defending a licensing application. Cultural and practice differences and similarities between the EU and USA will be explored. Instructor: Art Gertel Approximate homework time: 2-3 hours ESSENTIALS OF COPYEDITING [CP/EW] [3003] Copyediting—scrutinizing text for correctness, consistency, format and completeness, and clarity and accuracy—is required for all types of written material. This workshop, intended for beginning copyeditors, will focus on basic copyediting skills, not on specific language issues. 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. Instructor: Loretta Bohn Approximate homework time: 3 hours UNDERSTANDING SAMPLE SIZE AND STUDY POWER [ADV] [729] This workshop is intended for writers and editors who are familiar with basic biostatistics and research methods and who want to improve their understanding of and ability to communicate about sample size and study power. Various factors will be explored, particularly sample size and the influence of a study’s “power”—the ability to detect a measured and statistically significant effect. The workshop leader will also examine the role that precision and confidence intervals play in interpreting and reporting a study’s power. These concepts will be addressed from the vantage points of planning studies and of interpreting and assessing completed studies. The workshop leader will emphasize effectively communicating the related concepts to lay and professional audiences. It is recommended that participants have previously taken Statistics for Medical Writers and Editors and Basics of Epidemiology for Medical Communicators, and/or Interventional and Observational Research Design. Participants would also benefit from having taken Risks and Ratios. Instructor: Bart Harvey, MD, MSc, PhD, MEd, FRCPC, FACPM, MWC Approximate homework time: 3 hours NOTE: To receive course credit, you must submit workshop homework to the instructor by April 15, 2016. Workshop Acronym Key: ADV = Advanced; CP = Composition and Publication; EW = Core Editing/Writing; PH = Pharmaceutical; RR = Regulatory and Research; SG = General Science (previously offered certificate) AMWA Carolinas Spring Conference | May 6, 2016 | The Friday Center | Chapel Hill, NC 5

Open Session Descriptions Open Sessions (OS) do not have homework. THE ROLE OF MEDICAL WRITING IN PHARMACOECONOMICS AND OUTCOMES RESEARCH (OS) Instructors: Deirdre M. Mladsi and Shahnaz B. Khan, MPH The field of pharmacoeconomics and outcomes research aims to evaluate the clinical, economic, and humanistic value of treatment strategies, to aid in health care decision making, and to inform the allocation of health care resources. Deirdre M. Mladsi and Shahnaz B. Khan, MPH, both senior outcomes researchers at RTI Health Solutions, will present an overview of pharmacoeconomics (ie, analysis of the costs and consequences of a treatment) and outcomes research (ie, analysis of the clinical, humanistic, and economic end results of a treatment). This session will describe the basic principles of pharmacoeconomic analysis, the ways in which clinical data factor in to pharmacoeconomics and outcomes research, and the significance of this research to patients, clinicians, and health care payers. The presenters will also discuss the role of medical writers in this diverse field. CONTINUING MEDICAL EDUCATION (OS) Instructor: Monique Johnson, MD, CHCP To remain a relevant and useful strategic asset for improving healthcare and patient outcomes, CME must continue to change. Thus, it is critical that professionals whose role involves developing, writing, and editing in the CME space develop and hone skills related to conducting gap analyses, writing educational grant requests, developing content for CME-certified activities, and publishing or presenting educational effectiveness research. They must also stay abreast of regulatory and industry trends that guide how CME activities are developed to support the lifelong learning of clinicians. This session will provide an overview of the main CME stakeholders; principles and regulations that guide the development of CME activities; and key competencies and skills necessary to develop exemplary CME activities. Evolution of Medical Communicators: From Puppets to Masters of Integrity (OS) Instructor: Chantelle Rein-Smith, PhD, and Cindy W. Hamilton, PharmD, ELS Medical communicators are often perceived as spin doctors who do not add value to the publication process. Using ghostwriting as a model, this interactive session will review existing and new publication guidelines to more clearly define the role of the medical writer, as well as survey data showing that awareness of guidelines is associated with ethical behavior. Although the prevalence of unethical behavior appears to be decreasing, it is stubbornly persistent. Modeled after a similar session at the San Antonio Annual Conference, this session will use a new case study to review a multistep model for making ethical decisions—which in turn can be used to transform our image from being puppets to becoming masters of integrity. HOW TO LAUNCH A FREELANCE CAREER (OS) Panelists: Eugene Casale, PhD, Caryl Schwartzbach, PhD, and Ursula Jorch, MSc, MEd Have you ever dreamed about being a freelance medical writer, but the thought of launching and maintaining a business seemed too daunting? This interactive panel discussion aims to remove the mystery around incorporating, reviewing contracts, accounting, paying taxes, pricing, invoicing, marketing, investing, and insurance needs and will discuss the experience and skills you’ll need for your business to run smoothly and successfully. The panelists include both pharma and non-pharma writers who are either long-time or new freelances. Attendees should come prepared to ask about any aspect of launching and maintaining a freelance writing business. There’s plenty of freelance work out there. If it’s time for you to make the leap, this session is for you.

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Instructor Biographical Sketches Art Gertel is the principal of MedSciCom, LLC, an independent consultancy that provides independent and collaborative strategic regulatory consulting and medical writing services, as well as data safety monitoring board and bioethics expertise. He completed undergraduate studies in biology and psychology at the University of Pennsylvania and graduate work in neurophysiology and behavioral medicine at New York Medical College and in pharmaceutics at Temple University. For the past 3 years he has been a senior research fellow at the Centre for Innovation in Regulatory Science, a UK-based think tank funded by FDA, EMA, and PhRMA. He has worked for TFS (formerly Beardsworth Consulting Group, Schering-Plough, Hoffmann-La Roche, Revlon Health Care Group, iKnowMed, and Quintiles in tasks as varied as clinical documentation filed in support of new drug registrations, worldwide, publications, Web-based electronic data capture software to support pharmaceutical clinical trials, and project management for peri- and post-approval clinical trials. Art serves on the advisory board of an IRB and is cochair of the Alliance for Clinical Research Excellence and Safety (ACRES) Global Ethical and Regulatory Innovation (GERI) Steering Committee. He is also involved in the establishment of a bioethics community for the Drug Information Association. A founding member of the Global Alliance of Publication Professionals (GAPP), with a remit to clarify authorship standards, he has addressed this topic for AMWA, the European Medical Writers Association (EMWA), and ISMPP as well. He is collaborating with the Budapest Working Group in the establishment of a CORE (Clarity & Openness in Reporting) reference manual for clinical study reports. Under the auspices of CDISC, he has worked on data transformation standards for protocols, registries, and health records; chaired the CDISC Glossary Group; and served as a charter member of the CDISC Protocol Representation Group. Art is a past president of AMWA and a Fellow of both AMWA and EMWA, continuing to serve on committees and to lead workshops and plenary sessions. AMWA has recognized him with the Swanberg Award (2009) and the Eric Martin Award (2014). Bart Harvey, MD, MSc, PhD, MEd, FRCPC, FACPM, MWC, is an associate professor at the Dalla Lana School of Public Health at the University of Toronto and a full member of the university’s School of Graduate Studies. From 2003 to 2008, Bart served as the director of family and community medicine research; from 1996 to 2006 he directed the University of Toronto’s public health and preventive medicine residency program. He is the chair of the Royal College of Physicians and Surgeons of Canada's (RCPSC) CanMEDS 2015 Research Expert Working Group, a past president (2002–2004) of the Canadian National Specialty Society for Community Medicine, and past chair (2006–2012) of the RCPSC’s Specialty Committee for Public Health and Preventive Medicine. He has served three 3-year terms on the Board of the American College of Preventive Medicine and since 2001 has been a member of the American Board of Preventive Medicine’s Public Health and General Preventive Medicine Examination Committee. Bart has been a principal or co-author on dozens of papers published in peer-reviewed journals and has presented invited and peer-reviewed papers at national and international professional meetings. In recognition of his teaching excellence, Bart received AMWA’s Golden Apple Award in 2006. He was named an AMWA Fellow in 2009 and a Fellow of the American College of Epidemiology in 2011. He also served for many years as one of the City of Toronto’s investigating coroners. Caryl Schwartzbach, PhD, is the president and owner of PATH Clinical Development Services, LLC, providing medical writing and clinical development support services, a position she has held since 2015. She previously (1999–2015) held a variety of leadership positions at GlaxoSmithKline. Caryl has more than 23 years of experience in leading and delivering strategic, scientific, and operational objectives for Phase I–IV programs, including the design, writing, and review of a wide range of clinical and regulatory documents. She has been directly involved in the global clinical development of over 25 therapeutic programs, including the clinical development and licensing of eight marketed products—five with novel therapeutic targets and three new regulatory approvals. She is highly experienced in design and execution of clinical programs for NCEs with targeted strategies appropriate for the treatment and indication. Through optimizing clinical program design, teamwork, study execution, document development, and data quality, Caryl has a demonstrated commitment to developing and implementing innovative solutions that accelerate delivery of medicines to meet unmet medical needs of patients. Her experience in design and delivery of global clinical development programs spans multiple therapeutic areas, including neurosciences, respiratory, and novel research targets and study designs. With multiple approvals, she has in-depth understanding of ICH/GCP regulations governing clinical research, documentation, and reporting and global regulatory processes for EMA, FDA, and PMDA.

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Chantelle Rein-Smith, PhD, is a medical writer and consultant for Whitsell Innovations, Inc., a full-service medical and scientific writing company based in Chapel Hill, North Carolina. Chantelle earned a bachelor’s degree in biochemistry and molecular biology from Hamilton College (Clinton, New York) and a doctorate in medical and molecular genetics from Oregon Health and Science University. She has extensive experience in the preparation, editing, and quality control of clinical and nonclinical manuscripts and white papers, as well as experience in publication planning and the preparation of regulatory documents such as clinical study reports, new drug applications, and investigational new drug applications. Chantelle is also the events coordinator for the AMWA Carolinas Chapter. Cindy W. Hamilton, PharmD, ELS, is thrilled to return to her alma mater. She has served AMWA in many volunteer capacities since joining in 1984, most notably as a past president. Cindy received the Golden Apple Award in 2011 and the Swanberg Award in 2013. She enjoys leading workshops because of the opportunities to promote excellence in medical communication, to apply the principles of adult education, and to network with other AMWA members. Cindy especially likes workshops on tables and graphs and on posters because of the prospect for balancing content with design principles. She is principal of Hamilton House, a medical communication firm in Virginia Beach, Virginia. Deirdre (Dee Dee) M. Mladsi is head of Health Economics and Market Access at RTI Health Solutions (RTI-HS), applying standard methods and her experience to support the development and commercialization of pharmaceuticals, medical devices, and diagnostics. She has over 20 years of experience conducting health economics and outcomes research, including 5 years in the global health outcomes group of a leading research-based pharmaceutical company. As a consultant, Dee Dee, one of the founding senior members of RTI-HS, formed and led several teams within the organization; she served as one of the first directors of health economics and as the first global head of health outcomes strategy and the first global head of pricing and reimbursement. In her current role, Dee Dee blends her technical skills in health economics with her experience conducting strategic pricing, reimbursement, and market access projects, both with a global focus and with local pricing and reimbursement experts in markets around the world. Areas of specialization that blend health economics and market access include threshold analysis to estimate value-based price opportunity, given an expected product profile; valuation modeling to inform clinical development prioritization efforts; and decision support modeling targeted at payers and other health care market access decision makers. Eugene (Gene) Casale, PhD, obtained a bachelor’s degree in biology at the State University College at Oneonta (New York; 1979), a master’s degree in physiology at the University of Connecticut (Storrs; 1982), and a doctorate in physiology (with a strong emphasis in neurobiology) at the University of North Carolina, Chapel Hill (1988). Because of his interest in pursuing a career in applied science, Gene became a clinical research scientist (CRS) at Burroughs Wellcome Company in the department of clinical neuroscience (anesthesia/analgesia section) and worked on the first of numerous new drug applications (NDAs; for a neuromuscular blocker) over his career. Over the next several years, he worked on clinical development and NDA document authoring for three other neuromuscular blockers. Two of these NDA approvals involved working with the FDA on a live (video and phone feeds), interactive (and heroic!) pilot program called an “NDA Day” in which the company and the FDA attempted to answer critical application questions in a single day with the hope of speeding the approval process. Burroughs Wellcome merged with Glaxo in 1995 to form GlaxoWellcome, where Gene continued as a CRS in the epilepsy program (two more NDAs). After writing so many protocols, clinical study reports, integrated summaries, patient narratives, and investigator brochures, Gene decided that he was really a medical writer and joined the medical writing department at GlaxoWellcome, where he was the lead medical writer for programs in irritable bowel syndrome, benign prostatic hyperplasia, stroke, and malaria. He developed two more NDAs (IBS, BPH). In 2002, Gene joined Schwarz Biosciences as an associate director in the medical writing department. He was the lead medical writer for Schwarz’s first NDA for a prescription drug (Parkinson’s disease); the NDA was submitted as a fully electronic application in accordance with the relatively new and evolving guidelines for creating electronic submissions for regulatory review. In 2006, Gene launched his own freelance medical writing business, where he continued to focus on documents for the regulatory approval of drugs across a wide range of therapeutic areas. Most recently, Gene has also served as president-elect (2013–2014), president (2014–2015), and immediate past president (2015–2016) for the AMWA Carolinas chapter. Loretta Bohn, a senior editor/writer at RTI International, has more than 25 years of experience in editing, writing, and proofreading. Loretta helped develop RTI’s full-day in-house workshop on writing technical reports; she AMWA Carolinas Spring Conference | May 6, 2016 | The Friday Center | Chapel Hill, NC 8

facilitates it several times a year in both in-person and virtual formats and coaches writers individually on request. She has led AMWA workshops both locally and at the national conference and mentors RTI’s junior editors in applying style guides, composing diplomatic queries, and completing their work effectively and efficiently. Loretta’s current assignments at RTI, where she edits technical reports, proposals, and diverse journal submissions, concentrate in behavioral health, criminal justice, and health economics. Most recently she has been the lead editor for several interlocking evidence-based cross-site evaluations in substance abuse and HIV prevention. Loretta is the president-elect of the Carolinas chapter of AMWA. When not at her computer or in a chapter Executive Council meeting, she can often be found catering to the whims of her two cats or taking horseback riding lessons. Monique Johnson, MD, CHCP, entered the medical education field as an instructional design specialist and medical writer for pharmaceutical sales training materials, working at Education and Training Systems, International, based in Chapel Hill, North Carolina. Since 2002, she has worked as a content development professional at accredited medical education companies, with primary responsibilities in needs assessment and clinical content writing, outcomes planning, and mentoring new medical writers. Monique has been active in many professional organizations, including the Alliance for Continuing Education in the Health Professions, National Association of Medical Education Companies (NAMEC), and Commission for Certification of Healthcare CPD Professionals. She was the 2012 Exemplary CME Professional recognized by NAMEC and is a certified Healthcare CPD Professional. Monique earned a bachelor’s degree in biochemistry from North Carolina State University and a medical degree from the University of North Carolina at Chapel Hill School of Medicine. She completed her residency in pediatrics at Cincinnati Children’s Hospital Medical Center. Shahnaz Khan, MPH, is a senior director of Market Access and Outcomes Strategy at RTI-HS. Shahnaz has more than 16 years of experience working in medical communications, including 12+ years at RTI-HS, and has earned a certificate in medical writing from AMWA. Before joining RTI-HS, she served as a medical writer for two different contract research organizations. At RTI-HS, she conducts research projects related to literature reviews, global value dossiers, and Academy of Managed Care Pharmacy dossiers and develops pricing and reimbursement dossiers. Her extensive clinical writing experience includes preparation of protocols, clinical study reports, and manuscripts in the areas of ophthalmology, infectious diseases, cardiovascular disease, endocrinology, urology, gynecology, oncology, hematology, and neurology. Shahnaz also has considerable experience in the production of corporate health economics and outcomes research communication materials. Ursula Jorch, MSc, MEd is a business coach and medical communications consultant for pharma, biotech, and other life science companies. Her international clients include every major pharmaceutical company and many smaller enterprises. Ursula’s own entrepreneurial success began 20 years ago with a quick start. After 9 years in a corporate pharma job, she realized her own dream, starting a successful communications and training consulting company that exceeded her 6-figure corporate salary from her first year in business. In 2010, she sold her house and most of her belongings and took herself and her business on the road. Through that experience, she transformed her business to coach other entrepreneurs to create the businesses of their dreams. Ursula’s academic background includes a BSc in pharmacology, an MSc in pathology, and a master’s degree in adult education.

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AMWA Education Programs AMWA Certificate Program Information AMWA workshops allow medical communicators to increase their knowledge, refresh their skills, and investigate new areas. Credit workshops provide an interactive 3-hour learning experience with peers and AMWA’s expert workshop leaders. Depending on the content covered, workshops usually comprise 16 to 30 attendees and include real-life exercises and small-group breakouts. As the world of medical communication changes, the association updates existing workshops and develops new ones. More information is available online. Enrollment is required in order to earn an AMWA certificate. The enrollment fee is a one-time fee. Only enrolled participants can receive credits toward a certificate. Additional fees apply for workshop participation and self-study workbook purchases. You may earn an AMWA certificate by participating in 8 AMWA workshops in a content area. One of these workshops must be the ethics workshop applicable to that certificate, and for specialty certificates up to two workshops can be electives of your choice. AMWA awards the appropriate certificates when the requirements have been fulfilled. Please allow AMWA HQ staff sufficient time after the conference to process workshop credits. You may review your workshop curriculum history by logging in to www.amwa.org and clicking on “My Curriculum History” in the quick links under Account Management. Precourse Work (Homework) Each credit workshop includes homework. Typically, the purpose of the homework is to give participants needed background information for the workshop and also to help the workshop leader assess the skill levels of participants. Once you register for the conference, you will receive an e-mailed confirmation which will include the link for downloading homework from the AMWA website. We strongly encourage you to download homework immediately after you receive your confirmation to ensure that the downloading process is successful, to confirm that the homework is correct for the workshop, and to note the deadline stated on the specific homework. A delay in downloading the homework and identifying potential problems could result in the inability to complete the homework by the deadline. If you have difficulty accessing the homework, please contact AMWA HQ by e-mail at [email protected] or by telephone at 240-238-0940, ext. 103. You are also responsible for verifying that your workshop leaders have received your completed homework by the deadline of three weeks before the conference. Even if you do not wish to receive credit for a workshop, you are encouraged to complete the homework to be better prepared to fully participate in the workshop. In order for a registrant to attend an Advanced workshop, the homework must have been completed and received by the workshop leader no later than the specified deadline, even if credit is not desired.

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Conference Location The Friday Center is located off NC Hwy 54 in Chapel Hill, North Carolina. See www.fridaycenter.unc.edu for a map and more details about the venue.

Preconference Dinner Join us for a preconference dinner at the Tobacco Road Sports Café at 1118 Environ Way in Chapel Hill on Thursday, May 5, 2016, from 6:30 to 8:30 PM. Get to know fellow AMWA members in a relaxed environment before the conference begins. (The dinner will be held in a private room at the restaurant.) Tobacco Road offers a variety of entrée options and is conveniently located in East54 off Hwy 54 (less than a mile from the Friday Center). For restaurant information or directions, visit http://www.tobaccoroadsportscafe.com/location/chapelhill.html or call (919) 537-8404. You can indicate that you plan to attend the preconference dinner when you register online or email Chantelle ReinSmith at [email protected]. Please RSVP by Monday, May 2, 2016. Please note that attendees pay for their own food and beverages.

Hotel Information The Courtyard Marriott of Chapel Hill is on NC Hwy 54, within short walking distance of the Friday Center. The Hilton Garden Inn is located off I-40 on Fayetteville Road in Durham and is adjacent to The Streets at Southpoint mall. The Hilton Garden Inn is 10 miles from RDU International Airport and 7 miles from the Friday Center. Courtyard Marriott of Chapel Hill 100 Marriott Way Chapel Hill, NC 27517 Phone: (919) 883-0700 www.marriott.com/rduch

Hilton Garden Inn Durham Southpoint 7007 Fayetteville Road Durham, NC 27713 Phone: (919) 544-6000 www.hiltongardeninn.com

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