DIA 2013 49th Annual Meeting
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Pediatric Drug Development: A New Paradigm Under FDASIA
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
110
Date:
Monday, June 24, 2013
Time:
11:00 AM to 12:30 PM
EST
Location:
253A
CHAIR
:
Rosemary M. Addy, (SCHAGY), Supervisory Consumer Safety Officer, Office of New Drugs, CDER, FDA, United States
SPEAKER
(S):
Rosemary M. Addy, (SPKAGY), Supervisory Consumer Safety Officer, Office of New Drugs, CDER, FDA, United States
Chin Koerner, MS (SPKNON), Executive Director, Regulatory Policy, Novartis Pharmaceuticals Corporation, United States Paolo Tomasi, MD,PhD (SPKAGY), Head of Paediatric Medicines, European Medicines Agency, European Union, United Kingdom Christina Bucci Rechtweg, MD (SPKNON), Head, Pediatric & Maternal Health Policy, Novartis Pharmaceuticals Corporation, United States
Description
With the passage of the Food and Drug Administration Safety and Information Act (FDASIA), pediatric drug development has taken another step forward. This session will review the impact of this new paradigm on pediatric drug development.
This session is a part of:
This session is a part of: