DIA 48th Annual Meeting
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Global Product Development: Resolving Conflicting Scientific and Regulatory Advice from Multiple Health Authorities
Track : Track 08: Regulatory Affairs and Submissions
Program Code: 337
Date: Wednesday, June 27, 2012
Time: 10:00 AM to 11:30 AM  EST
CHAIR :
 Shannon Strom, Pearl Therapeutics, Inc., United States
PRESENTER (S):
 Jenny Vestal, Aptiv Solutions, United States
 Cynthia Girman, Merck Research Laboratories, United States
 Stephen Thompson, S-Cubed, Ltd., United Kingdom
Description
When a company seeks regulatory or scientific advice from multiple health authorities, the regulators can provide divergent recommendations. This session will discuss strategies to resolve differing feedback and develop a global development strategy.

Learning Objectives:
Recognize common reasons for divergent scientific and regulatory recommendations from global health authorities
Develop approaches to collaborate with health authorities to resolve different opinions
Integrate feedback from health authorities into a unified global product development strategy.