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DIA 2018 Global Annual Meeting

‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017

    Session Chair(s)
      Melodi J McNeil, MS, RPh

      Melodi J McNeil, MS, RPh

      • Director
      • 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

      Industry Perspective

      Christina Bucci-Rechtweg, MD

      • Global Head, Pediatric and Maternal Health Policy, Drug Regulatory Affairs
      • Novartis Pharmaceuticals Corporation, United States
      Representative Invited

      FDA Perspective

      Representative Invited

      • FDA, United States
      Representative Invited

      EMA Perspective

      Representative Invited

      • European Medicines Agency (EMA), United Kingdom