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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
Hylton Joffe, MD
FDA, United States
Director, Office of Cardiology, Hematology, Endocrinology Nephrology,
Panelist
Elizabeth Hart, MD
FDA, United States
Branch Chief, General Medicine 1, OTAT, CBER
Panelist
Janet Maynard, MD, MHS
FDA, United States
Director, Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine
Panelist
Kelly Robinson, MSc
Health Canada, Canada
Director General, Marketed Health Products Directorate
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