Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols
Track
:
Track 19: Communities Showcase
Program Code:
324
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
205A
CHAIR
:
Helle Gawrylewski, MA (SCHNON), Senior Director, Regulatory Medical Writing, Janssen Research & Development, LLC, United States
Head Med Affairs/ MW Alliances, previously director of Early Development and multiple therapeutic area writing at J&J for over 15yrs. 2-term MW SIAC Chair, and CDISC Protocol Rep/Glossary Group from 2001.Held positions of increasing responsibility in MW and management for 38+ years.
SPEAKER
(S):
Julie A. Ely, PhD (SCHNON), Senior Medical Writer, Proscribe Medical Communications, Australia
In her role as manager and senior medical writer for ProScribe Medical Communications, a virtual company based in Australia, Julie enjoys working in a variety of therapeutic areas with clients from academia and industry. Our clients are located both in the Asia-Pacific region and around the world.
Ken is the chairman of CISCRP and a Senior Research Fellow at the Tufts Center for the Study of Drug Development. A well-known speaker and author, Ken holds an MBA from Northwestern University and a bachelor’s degree from Brandeis University.
Nancy R. Katz, PhD (SPKNON), President and Principal Medical Writing Consultant, Illyria Consulting Group, Inc., United States
Description
SPIRIT was a systematic development of a 33-item checklist for minimum content of a clinical trial protocol. This session will explore its applicability in nonpharmaceutical company sponsored trials and noninterventional studies.
This session has been developed by the Medical Writing Community.