‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017
Melodi J McNeil, MS, RPh
AbbVie, Inc., 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.
Christina Bucci-Rechtweg, MD
Global Head, Pediatric and Maternal Health Policy, Drug Regulatory Affairs
Novartis Pharmaceuticals Corporation, United States
FDA, United States
European Medicines Agency (EMA), United Kingdom