戻る Agenda
Global Pediatric Development: Next Steps
Session Chair(s)
Chin Koerner, MS
Executive Director, Development and Regulatory Policy
Novartis , United States
With the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the permanent reauthorization of the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA), the promise of earlier and meaningful interactions with FDA regarding pediatric drug development is now a reality. This coupled with the EU Pediatric Legislation that provides for a required and predictable process for pediatric discussions with EMA, sets the stage for global pediatric development programs that can align with needs of children and address concerns of the FDA and EMA.
In this session we will explore initiatives that each FDA and EMA oversee to advance pediatric research. We will also explore those initiatives the Health Authorities are undertaking together to better advance unmet and underserved needs of children. Updates on monthly cluster calls, joint FDA/EMA pediatric program review, the EMA five year report, and use of MedDRA® to help identify additional pediatric studies needed will be just some of the topics to be discussed.
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