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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
Ilan Irony, MD
Janssen Pharmaceutical Companies of Johnson and Johnson, United States
Senior Director, Global Regulatory Leader
Panelist
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER
Panelist
Janet Maynard, MD, MHS
FDA, United States
Director, Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine
Panelist
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
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