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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/Health Canada programs available to expedite the development of orphan products; Recognize new regulatory initiatives and policy developments related to orphan drug review.
Speaker(s)
Panelist
Director, Office of Cardiology, Hematology, Endocrinology Nephrology, , FDA, United States
Panelist
Branch Chief, General Medicine 1, OTAT, CBER, FDA, United States
Panelist
Director, Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine, FDA, United States
Panelist
Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
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