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Global Pediatric Development: We Are Making Progress
Session Chair(s)
Chin Koerner, MS
Executive Director, Development and Regulatory Policy, Novartis , United States
Representatives from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceutical and Medical Device Agency (PMDA) will provide the latest regional policy developments, share examples of similar policies and agreements and share examples where the agencies differ.
Learning Objective : Discuss the latest policy developments in the three regions in pediatric research.
Speaker(s)
Junko Sato, PHD
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Into the Future: Go Global Pediatric Development Forward for Children Worldwide — Beyond Current Regulations
Mary Dianne Murphy, MD
Director, Office of Pediatric Therapeutics, Office of Special Medical Programs, FDA, United States
FDA Perspective
Jordi Llinares Garcia, MS
Head of Research and Innovation, European Medicines Agency, Netherlands
EMA Perspective
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