AMWA – Carolinas Chapter
American Medical Writers Association – Carolinas

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Spring Conference

|Conference Schedule | Workshop Descriptions | Open Sessions |Roundtable Lunch Discussions |

2016 Spring Conference

Online registration for our chapter’s annual Spring conference is now open. Click here to register!

The conference will be held on Friday, May 6, at the Friday Center in Chapel Hill, NC. In addition to the great workshops being offered, this year we have a lineup of engrossing talks, covering topics such as manuscript writing and ethics, pharmacoeconomics and outcomes research, continuing medical education, and how to launch a freelance career.

Registration will be limited to the first 30 paid applicants for each workshop and to the first 35 paid applicants for each open session so be sure to register early!

May 6, 2016 Schedule

Conference Registration & Breakfast (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

OPEN SESSIONS (8:30-11:45 AM)

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.

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ROUNDTABLE LUNCH DISCUSSIONS (11:45–1:00 PM)

Newcomers Corner
Leader: Ashley Godfrey, PhD, RAC
Clinical Research Scientist, IMPACT Pharmaceutical Services

Computer-Generated Models: Reporting Study Results
Leader: September Mihaly, PhD, RAC
Regulatory Writer, Synchrogenix

How to Deal With a Grumpy Client
Leader: Robin Whitsell, BPh
President, Whitsell Innovations, Inc.

Quality Control for Regulatory Submissions
Leader: Suzy Lawton, RAC, CCRP
Owner/Medical Writer, Lawton Clinical

The Importance of Soft Skills for Medical Writers
Leader: Lori Rochelle, PhD
Senior Medical Writer, Inventiv Health

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
Leader: Margaret Mathes
Medical Editor, RTI Health Solutions

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 (1:15-4:30 PM)

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 2:45 PM.

SOCIAL HOUR (4:30–6:00 PM)

Details to be announced in registration packet.

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AMWA Credit 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. 

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AMWA Open Session Descriptions

The Role of Medical Writing in Pharmacoeconomics and Outcomes Research (OS)
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.
Speakers: Deirdre M. Mladsi and Shahnaz B. Khan, MPH

Trends and Transformations in CME: Interpretations and Implications for Medical Writers and Editors (OS)
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.
Speaker: Monique Johnson, MD, CHCP

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

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

 

Conference Sponsors

Thank you to our sponsors: UCB Biosciences, Synchrogenix and Impact Pharmaceutical Services!

UCB Logo         Synchrogenix        

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Last modified: April 30, 2016