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Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?
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 Section 504 represent a significant paradigm shift in pediatric oncology development. This session will review these requirements and their likely global impacts, as well as possible mitigation strategies.
Learning Objective : Describe and explain the new provisions in FDARA Section 504 that will impact pediatric oncology development in the US within the context of the EU requirements; Analyze the implications and assess the impact of these new provisions on global pediatric oncology development; Describe the use of Master Protocols as a possible mitigation strategy.
Speaker(s)
Industry Perspective: Industry Perspective: Master Protocols as an Option to Design and Conduct Pediatric Oncology Studies under FDARA, Sec 504
Pamela Lyncee Simpkins, MBA
Mezzopointe. LLC, United States
Managing Partner
FDARA 504 Overview/Implementation Planning
Gregory Reaman, DrMed, MD
FDA, United States
Associate Director for Pediatric Oncology , OCE, OC
Lessons Learned from Two Public-Private Partnership Master Protocols
Stacey J. Adam, PHD
Foundation for the National Institutes of Health (FNIH), United States
Director, Cancer Research Partnerships