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DIA 2018 Global Annual Meeting


Global Rare Disease Town Hall

    Session Chair(s)
      James E. Valentine, JD, MHS

      James E. Valentine, JD, MHS

      • Attorney
      • Hyman, Phelps & McNamara, PC, United States
    Rare disease drug development is exploding and, in light of both old and new incentives programs to encourage drug development, the challenges of bringing these products to market continue to persist. Exploring the scientific and regulatory issues with experts to provide insights from those with the most experience in both successful and failed rare disease drug proposals.This forum will address the unique regulatory complexities and challenges specific to orphan drug development. It will provide key information about programs available to expedite the development of orphan products and will include audience Q&A.
    Learning Objective : Identify unique regulatory complexities and challenges specific to orphan drug development; Describe FDA programs available to expedite the development of orphan products; Recognize FDA requirements related to orphan drug regulation under 21st Century Cures and PDUFA VI.
    Speaker(s)
      Representative Invited

      EMA Perspective

      Representative Invited

      • European Medicines Agency (EMA), United Kingdom
      Representative Invited

      FDA Perspective

      Representative Invited

      • FDA, United States
      Representative Invited

      FDA Perspective

      Representative Invited

      • FDA, United States