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Pediatric Drug Development: Lessons Learned During FDASIA Implementation

Regulatory Affairs and Submissions

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:

Room Number:



Pediatric Drug Development: Lessons Learned During FDASIA Implementation

Rosemary M. Addy
Supervisory Consumer Safety Officer, Office of New Drugs, CDER
FDA, United States

Now that the pediatric study plan required under the Food and Drug Administration Safety and Information Act (FDASIA) has been implemented, this session will review lessons learned from both an FDA, discuss how to coordinate with European pediatric inverstigational plan (PIP) and include an industry perspective.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
You Want Us to Withdraw our PSP? A PSP Case Study
Betsy J. Waldheim
Senior Director, Regulatory Affairs
Eisai Inc., United States

Pediatric Study Plans: Examples Across One Company's Pipeline
Lisa L. Mathis, MD
Executive Director, Global Regulatory Affairs and Safety
Amgen Inc., United States

Early Experiences with Title V Post-FDASIA Across the Industry
Christina Bucci-Rechtweg, DrMed, MD
Head, Pediatric and Maternal Health Policy, Global Drug Regulatory Affairs
Novartis Pharmaceuticals Corporation, United States