AMWA – Carolinas Chapter
American Medical Writers Association – Carolinas

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Spring Conference

|Conference Schedule | Workshop Descriptions | Open Sessions | Roundtable Lunch Topics | Conference Sponsors

 

The May 1, 2015 Conference was held in Chapel Hill, NC

registration table

Registration 2015

Download the May 1st 2015 conference brochure[PDF].

Conference Costs:
The conference attendance fee included a continental breakfast, lunch roundtables and open sessions

Day of Conference (only checks were accepted)
$110 AMWA Members
$110 Full-time Students and post-doctoral fellows (with AMWA promotional code)
$170 Non-members

AMWA Credit Workshop(s):
Registration and homework had to be submitted before April 10, 2015.

$125 per workshop for AMWA Members
$210 per workshop for non-members

Questions:
For information on certificate enrollment or registration questions visit the national AMWA website, e-mail amwa@amwa.org or call (240) 238-0940 x 103
For program or conference related questions, e-mail the AMWA Carolinas Chapter President, Eugene Casale at cpresident(at)amwacarolinas.org

 

May 1, 2015 Schedule

Breakfast and Conference Registration: 7:45 AM – 8:30 AM

networking-Conf-2015

networking

 

Morning Sessions: 8:30 AM – 11:45AM
Tables and Graphs
8:30 AM – 11:30 AM
AMWA Credit Workshop (Essential Skills / Core General) [2011]
Presenter: Cindy Hamilton, Pharm D. ELS

Summarizing Clinical Safety Data for a New Drug Application
8:30 AM – 11:30 AM
AMWA Credit Workshop (Regulatory and Research) [4014]
Presenter: Peggy Boe, RN

Developing Measures of Estrogen Response in Infants
8:30 AM – 10:00 AM
Open Session
Presenter: Walter Rogan, MD, MPH

Strategies for Strong Partnerships: Medical Writing Functional Service Providers
10:15 AM – 11:45 AM
Open Session
Presenters: Dayle H Cohen, PhD, RAC, Joanna Harris

 

Lunch Buffet with Roundtable Discussions: 11:45-1:00 pm

Buffet lunch

Buffet lunch

 

Afternoon Sessions: 1:00 – 4:15 PM
Creating Effective Poster Presentations
1:00 PM – 4:00 PM
AMWA Credit Workshop (Composition and Publication / Core Editing & Writing /Pharmaceutical) [3001]
Presenter: Cindy Hamilton, PharmD, ELS

Statistics for Medical Writers & Editors
1:00 PM – 4:00 PM
AMWA Credit Workshop (Essential Skills/Core General/Science-General) [2010]
Presenter: Bart Harvey, MD, MSc, PhD, MEd, FRCPC, FACPM

Assembling Clinical Study Report Appendices: A Tough Job but Somebody Has to Do It
1:00 PM – 2:30 PM
Open Session
Presenter: Susan Sisk, PhD, RAC

Making Science Simple for the General Audience
2:45 PM – 4:15 PM
Open Session
Presenter: Tom Linden, MD

 

Social Hour 4:15 PM – 6:00 PM

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AMWA Credit Workshop Descriptions

Statistics for Medical Writers and Editors (Essential Skills/Core General/Science-General) [2010]

AMWA Credit Workshop
Presenter: Bart Harvey, MD, MSc, PhD, MEd, FRCPC, FACPM

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

 

Tables and Graphs (Essential Skills/Core General) [2011]

AMWA Credit Workshop
Presenter: Cindy Hamilton, Pharm D. ELS

The workshop leader will cover definitions and uses of tables and graphs, as well as guidelines for preparing and editing them. The focus of the workshop, designed for the beginner, is the preparation of tables and graphs that are usable, that communicate, and that are appropriate for the situation. Participation is encouraged as we evaluate problematic tables and graphs. APPROXIMATE HOMEWORK TIME: 3-4 HOURS.

 

Creating Effective Poster Presentations (Composition and Publication / Core Editing & Writing /Pharmaceutical) [3001]

AMWA Credit Workshop
Presenter: Cindy Hamilton, PharmD, ELS
This interactive workshop is designed for beginning to intermediate poster creators, and the leader will cover everything from planning to production. Participants will learn about creating a poster from an abstract, developing structured versus unstructured content, selecting effective graphic presentation methods, and dealing with production issues. Attendees will evaluate sample posters and suggest improvements for layout and content. APPROXIMATE HOMEWORK TIME: 3 HOURS.

 

Summarizing Clinical Safety Data for a New Drug Application (Regulatory and Research) [4014]

AMWA Credit Workshop
Presenter: Peggy Boe, RN
This workshop is appropriate for regulatory/medical communicators who are moderately experienced in writing clinical regulatory documents. The teaching style will be primarily lecture with an exercise and some opportunity for discussion. The workshop leader will focus on what regulatory/medical communicators need to know to effectively write the high-level clinical safety documents required specifically by the Food and Drug Administration for US New Drug Applications (NDAs), namely the Module 5.3.5.3 Report of Integrated Safety Analysis (ISS) versus the Module 2.7.4 Summary of Clinical Safety. Associated regulations and guidelines will be discussed, as well as the source documents and other tools needed for generating these documents. APPROXIMATE HOMEWORK TIME: 2–3 HOURS.

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AMWA Open Sessions

Assembling Clinical Study Report Appendices: A Tough Job but Somebody Has To Do It

Open Session
Instructor: Susan Sisk, PhD, RAC

While most of the attention during clinical study report (CSR) writing and review is focused on the body text and synopsis, the majority of the page count is found in the appendices. Although the International Conference on Harmonization E3 guideline gives a good outline of these sections, the practical implementation often leaves the clinical team with questions about formatting and depth of content. This presentation provides step-by-step instructions on how to collect the information for each appendix and includes examples of forms that can be used for various sections. In addition, our speaker offers tips on how to assemble many of these items as the protocol is ongoing, with a goal of streamlining electronic-investigational new drug (e-IND) and electronic-new drug application (e-NDA) lifecycle submissions. THERE IS NO HOMEWORK FOR OPEN SESSIONS.

 

Strategies for Strong Partnerships: Medical Writing Functional Service Providers

Open Session
Instructors: Dayle H Cohen, PhD, RAC, Joanna Harris

Functional service provider arrangements provide a unique outsourcing opportunity for medical writing CROs and a consolidated, consistent service platform for clients. The success of these relationships relies heavily on the ability of the service provider to set, understand, and meet expectations, which may vary by client, size of the relationship, and scope of work. Many of the same strategies that make an FSP relationship successful underscore positive interactions between individual medical writing service providers (freelancers) and their customers. This presentation will share some of the key elements for defining, operationalizing, and meeting or exceeding the needs of clients. THERE IS NO HOMEWORK FOR OPEN SESSIONS.

 

Developing Measures of Estrogen Response in Infants

Open Session
Instructor: Walter Rogan, MD, MPH

Before ultrasound dating of pregnancy was possible, Roberta Ballard at Cincinnati Children’s Hospital had developed a method for estimating gestational age at birth from, among other things, how strongly the newborn was affected by maternal estrogen. She noted that the external genitalia and the breast tissue in both sexes changed rapidly late in gestation, as maternal estrogen increased exponentially before dropping to almost 0 at term. We wanted to find ways to study a newborn’s exposure to estrogen, and we thought we could begin by using Ballard’s scale in reverse. Breast tissue, cells from an infant girl’s introitus, cells from a boy’s distal urethra, and endometrium can all be used as indicators of the presence of significant amounts of estrogen. We recently completed a study using the plant estrogen in soy formula as the model exposure and multiple measures of estrogen effect in 270 infants followed from birth to 7-9 months. We tested the hypothesis that the soy would prolong the physiologic estrogenization of the newborn, compared to cow milk-based formula or breast milk. THERE IS NO HOMEWORK FOR OPEN SESSIONS.

 

Making Science Simple for the General Audience

Open Session
Instructor: Tom Linden, MD

Science and medical writers have a difficult job turning arcane research into plain English. No matter the medium –whether text, audio or video – the task is to tell stories that resonate with the audience. To do that, writers must have a good grasp of narrative and know how to explain complex science through stories and characters whom audiences can identify with. THERE IS NO HOMEWORK FOR OPEN SESSIONS.

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Roundtable Lunch Discussions

Authoring for Electronic Publishing
11:45 AM – 1:00 PM
Roundtable lunch discussion
Leader: BJ Witkin, Regulatory Publishing Manager, Impact Pharma

How to Know When the Price is Right: Pricing for Your Writing Business
11:45 AM – 1:00 PM
Roundtable lunch discussion
Leader: Ursula Jorch, MSc, Med, Founder, Jorch Consulting, LLC

Ursula Jorch's roundtable

Ursula Jorch’s roundtable

Lunch with the President of AMWA
11:45 AM – 1:00 PM
Roundtable lunch discussion
Leader: Karen Potvin Klein, MA, ELS, Associate Director, Office of Research, Wake Forest University Health Sciences, Winston-Salem, NC

Personal Branding
11:45 AM – 1:00 PM
Roundtable lunch discussion
Leader: Robin Whitsell, BA, BPh, President, Whitsell Innovations, Inc.

The Importance of Soft Skills for Medical Writers
11:45 AM – 1:00 PM
Roundtable lunch discussion
Leader: Lori Rochelle, PhD, Senior Medical Writer, Inventiv Health

Writing the biography of Frank H. Netter, MD
11:45 AM – 1:00 PM
Roundtable lunch discussion
Leader: Francine Mary Netter, BA, MA, MBA, Author, Raleigh, NC

Francine Netter's roundtable

Francine Netter’s roundtable

Writing the Clinical Study Report Synopsis: Reduce, Recycle, Reuse
11:45 AM – 1:00 PM
Roundtable lunch discussion
Leader: Susan Sisk, PhD, RAC, Owner, SFP Consulting

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Conference Sponsors

Thank you to our sponsors: UCB and Valesta!

UCB Logo
UCB is a global biopharmaceutical company focused on disorders of the immune and central nervous systems.

Valesta Valesta provides highly skilled clinical research professionals to the international life sciences, technology, and healthcare sectors.

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Last modified: May 22, 2015