DIA 48th Annual Meeting
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Wrangling the Bestiary of Safety Documents: Coordination and Integration across Multiple Requirements
Track
:
Track 06: Medical Writing and Medical Communications
Program Code:
131
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Aaron Van Etten, Amgen Inc., United States
PRESENTER
(S):
Sandra Hecker, Hecker & Associates, LLC, United States Jan Sechler, Janssen Research & Development, LLC, United States
Michael Hoffman, United BioSource Corporation, United States
Description
Medical writers' approaches to authoring pre- and postmarketing safety documents will be discussed with emphasis on meeting multiple, international requirements for products at various stages of development.
Learning Objectives:
Identify medical writers' strategies for authoring safety documents (eg, IB, DSUR, PIP, RMP, REMS, PV reports) with overlapping content
Identify different approaches to integrating multiple, international requirements for safety documents for products at various stages of development.
Learning Objectives:
Identify medical writers' strategies for authoring safety documents (eg, IB, DSUR, PIP, RMP, REMS, PV reports) with overlapping content
Identify different approaches to integrating multiple, international requirements for safety documents for products at various stages of development.
This session is a part of:
Handout Online
