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| ©
2003-2009 AMWA Carolinas. All rights reserved. |
Roundtable Lunch
(Aug)
| Roundtable Dinner (Sep)
Chapter Officer Voting | Web Manager Volunteer Position
Chapter Officer Voting | Web Manager Volunteer Position
ROUNDTABLE LUNCH (August)
Writing for the Electronic Common Technical Document (eCTD): Authoring Documents to Expedite Efficient Publishing
(Plan
to gather in the lobby of the PPD building at 3900 North Paramount
Parkway and you'll be escorted to the meeting room.)
*Please note this date falls on the 3rd Thursday of the month rather than our typical 2nd-Thursday events.
Authors and publishers of eCTD components need to work together to streamline document production and finalization. Susan Sisk will provide an overview of what medical writers and editors need to know about writing for eCTDs. The main topics covered in this talk will be use of authoring templates and style guides, rules for scanning documents, hyperlinking considerations, and electronic publishing quality control processes. This presentation is designed to provide attendees with practical tips for writing documents destined to become components of an electronic submission. In addition, we will cover some issues to consider when setting up processes and writing conventions.
Guest Speaker BioSketch
Dr. Susan Sisk has been designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products since 1995. In 2001, she joined Schwarz Biosciences as a regulatory project leader and FDA liaison, then helped build a high-performance medical writing group, including setting up company infrastructure such as SOPs, regulatory document guidances and templates, writing conventions, and quality control specifications. Her work at Schwarz included process management and preparation of marketing applications for FDA and European regulatory authorities using the CTD format for both paper and electronic submissions. In early 2006, she founded SFP Consulting, LLC, a company providing medical writing services and training as well as regulatory submissions project management to support development of healthcare products.
ROUNDTABLE DINNER (September)
Writing for CME: Topics at the Forefront
Date:
Thursday, September 10
Time: 6:30 PM
Location: An Cuisine, 2800 Renaissance Park Place, Cary, NC
Time: 6:30 PM
Location: An Cuisine, 2800 Renaissance Park Place, Cary, NC
Cost:
Presentation is Free; Participants are responsible
for their own dinner bill
RSVP: By September 9 to Ellen Stoltzfus
RSVP: By September 9 to Ellen Stoltzfus
Presentation Summary
Monique Johnson, MD will lead an interactive discussion about the changing CME landscape and how medical writers can best don a “CME hat” as they plan and prepare content for CME activities. We will discuss why it is imperative to craft gap-based needs assessments, how to use desired learner outcomes to begin writing content, and how “politics” may influence how and what you write in the future.
Guest Speaker BioSketch
Dr. Monique Johnson has been designing, writing, and reviewing medical education curricula since 1997. In 2000, she joined the CME division of Sandler & Recht Communications (now S&R Communications) as a medical content specialist and CME liaison. She facilitated the transition of this division into the high-performance, independent CME company, Scienta Healthcare Education, in 2005 and became medical director. During her career she has been involved in writing CME content, conducting gap-based needs assessments and outcomes analyses, mentoring junior writers, collaborating with seasoned freelance writers, and being actively involved in CME professional organizations (ACME, NC-CME, and NAMECC).
If you are a current AMWA Carolinas Chapter
member, it's time to vote for the 2009-2010 chapter officers! Contact Ellen Stoltzfus for a ballot.
Results will be announced on the AMWA Carolinas Website and by e-mail
to the listserv in September. The 2009-2010 officers begin their terms
in October and serve for one year. The president-elect will become the
president the following year (2010-2011 term).
This year's nominees:
- President-elect: Jennifer Bridgers, MS, and Tecca Wright, MA
- Secretary: Vivian McGee, MTSC
- Treasurer: Lori Rochelle, PhD
VOLUNTEER
TO BE THE WEB MANAGER
We are looking for someone to manage the AMWA
Carolinas Website. This is not an officer position and is not very time
consuming. However, the Website Manager must update the calendar at
least 1 to 2 times per month. If you are interested in the Website
Manager position, please contact Ellen
Stoltzfus for more information.
OTHER VOLUNTEER OPPORTUNITIES
- Submit topic or speaker ideas for bimonthly discussion dinners or special events
- Lead a dinner discussion on a topic of interest to AMWA
members
- Help plan or organize some of our chapter events (networking lunches, discussion dinners, special events, spring conference)
- Write articles for our monthly news flash
- Take photos at chapter events
- Mentor a new medical writer or editor
Last updated: August 18, 2009