DIA 48th Annual Meeting
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An Ocean Apart? Integrating Distinct Health Authority Philosophies on Personalized Medicines and Companion Assays
Track : Track 08: Regulatory Affairs and Submissions
Program Code: 250
Date: Tuesday, June 26, 2012
Time: 1:30 PM to 3:00 PM  EST
CHAIR :
 Jeffrey Stuart, Novartis Pharmaceuticals Corporation, United States
PRESENTER (S):
 Elizabeth Mansfield, FDA, United States
Linda Burdette, Hoffman-La Roche Inc., United States
 Marisa Papaluca-Amati, European Medicines Agency, United Kingdom
Description
Recently FDA and EMA released guidance to assist with co-development, but creation of a global registration strategy remains challenging. This session will bridge diverse regulatory perspectives to accelerate global co-development efforts.

Learning Objectives:
Summarize synergies and divergences between various health authority policies on co-development and co-registration
Apply information to form pragmatic global development and registration strategies for co-developed medical products.