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Session 2 - International Update: Priorities and Hot Topics
Session Chair(s)
Mary Dianne Murphy, MD
Director, Office of Pediatric Therapeutics, Office of Special Medical Programs
FDA, United States
Speaker(s)
Harmonization on a Global Stage: Progress and the Common Commentary
Jean Temeck, MD
FDA, United States
Lead Medical Officer, Office of Pediatric Therapeutics, OC
How the EU Paediatric Regulation has Delivered on Better Information for Medicines for Children
Paolo Tomasi, MD, PhD
European Medicines Agency, Netherlands
Head of Paediatric Medicines
Jordi Llinares Garcia, MS
European Medicines Agency, Netherlands
Head of Research and Innovation
PMDA's Experiences and Challenges in Pediatric Drug Development
Motoko Ishikawa, MS
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug III
Panel Discussion
All Session Speakers, United States
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