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Session Chair(s)
Chin Koerner, MS
Executive Director, Development and Regulatory Policy
Novartis , United States
Learning Objective : Discuss FDA and EMA initiatives undertaken to advance pediatric research and better align with the needs of children and public health.
Speaker(s)
Cluster Activities Including Joint Review Pilot and Other Harmonization Initiatives
Mary Dianne Murphy, MD
FDA, United States
Director, Office of Pediatric Therapeutics, Office of Special Medical Programs
EU Update: The Five Year Report and Streamlining Pediatric Investigation Plan Processes
Paolo Tomasi, MD, PHD
European Medicines Agency, Netherlands
Head of Paediatric Medicines
A Bridge From Here to There
Janet Jenkins-Showalter
Genentech, A Member of the Roche Group, United States
Head, US Regulatory Policy
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
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