×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
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)
You Want Us to Withdraw our PSP? A PSP Case Study
Betsy J. Waldheim
Eisai Inc., United States
Vice President, Regulatory Affairs
Pediatric Study Plans: Examples Across One Company's Pipeline
Lisa L. Bollinger, MD
Amgen, United States
Vice President, Global Patient Safety and Pediatrics
Early Experiences with Title V Post-FDASIA Across the Industry
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
Have an account?