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Pediatric Drug Development: Lessons Learned During FDASIA Implementation
Session Chair(s)
Rosemary M. Addy, MHS
Supervisory Consumer Safety Officer, Office of New Drugs, CDER, FDA, United States
You Want Us to Withdraw our PSP? A PSP Case Study
Learning Objective : Identify best practices of developing pediatric study plans to coordinate with European pediatric investigational plan (PIP); Apply the new pediatric laws to current drug development.
Speaker(s)
Betsy J. Waldheim
Vice President, Regulatory Affairs, Eisai Inc., United States
You Want Us to Withdraw our PSP? A PSP Case Study
Lisa L. Bollinger, MD
Vice President, Global Patient Safety and Pediatrics, Amgen, United States
Pediatric Study Plans: Examples Across One Company's Pipeline
Christina Bucci-Rechtweg, MD
Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
Early Experiences with Title V Post-FDASIA Across the Industry
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