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Pediatric Drug Development: A New Paradigm Under FDASIA
Session Chair(s)
Rosemary M. Addy, MHS
Supervisory Consumer Safety Officer, Office of New Drugs, CDER
FDA, United States
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.
Learning Objective : Identify current laws and regulations that govern pediatric drug development; Identify how to apply the new pediatric laws to current drug development.
Speaker(s)
Using FDASIA to Move Forward with Pediatric Drug Development
Rosemary M. Addy, MHS
FDA, United States
Supervisory Consumer Safety Officer, Office of New Drugs, CDER
Global Pediatric Development Programs: Are We There Yet?
Chin Koerner, MS
Novartis , United States
Executive Director, Development and Regulatory Policy
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
EU Perspective
Paolo Tomasi, MD, PhD
European Medicines Agency, Netherlands
Head of Paediatric Medicines
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