DIA 48th Annual Meeting
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Efficient Regulatory Medical Writing for Global Submissions Including "ICH Outlier" Authorities
Track : Track 06: Medical Writing and Medical Communications
Program Code: 333
Date: Wednesday, June 27, 2012
Time: 10:00 AM to 11:30 AM  EST
CHAIR :
 Justina Molzon, FDA, United States
PRESENTER (S):
 Beate Roder, PAREXEL International, Germany
Frank Hubbard, Astrazeneca Pharmaceuticals LP, United States
Description
This session will explore global medical writers' proven strategies for authoring regulatory submission documents for clinical trial and marketing applications with overlapping content being submitted virtually simultaneously to different regional authorities.

Learning Objectives:
Identify medical writers' proven strategies for authoring regulatory submission documents for clinical trials
Discuss the marketing applications with overlapping content being submitted virtually simultaneously to different regional authorities.