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Global Rare Disease Town Hall
Session Chair(s)
James Valentine, JD, MHS
Director, Hyman, Phelps & McNamara, PC, United States
FDA and international regulators will address unique regulatory complexities and challenges specific to orphan product development. It will provide key information and updates about programs available to expedite orphan drug development and include audience Q&A.
Learning Objective : Identify unique regulatory complexities and challenges specific to orphan drug development; Describe FDA and EMA programs available to expedite the development of orphan products; Recognize new regulatory initiatives and policy developments related to orphan drug review.
Speaker(s)
Panelist
Senior Director, Global Regulatory Leader, Janssen Pharmaceutical Companies of Johnson and Johnson, United States
Panelist
Consultant, Peter Stein Consulting, LLC, United States
Panelist
Director, Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine, FDA, United States
Panelist
Head of Division International Affairs, European Medicines Agency, Netherlands
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