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‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017
Session Chair(s)
Melodi J McNeil, MS, RPH
Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development
AbbVie, United States
The new requirements in FDARA Title V will substantially impact the conduct of pediatric oncology research globally. This session will explore the pediatric provisions in FDARA Title V, assess feasibility challenges in pediatric oncology drug development, and how they may be impacted by the new provisions in law, and will assess the potential global impact of FDARA. Session will include an interactive, global Q&A session with the audience and panel.
Learning Objective : Describe and explain the new provisions in FDARA 2017 Title V that will impact global pediatric oncology development going forward; Analyze the implications and assess the impact of these new provisions on global pediatric oncology development.
Speaker(s)
Industry Perspective
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
FDA Perspective
Lynne Yao, MD
FDA, United States
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
EMA Perspective
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs