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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Global Rare Disease Town Hall

Session Chair(s)

James  Valentine, JD, MHS

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)

Hylton  Joffe, MD

Panelist

Hylton Joffe, MD

FDA, United States

Director, Office of Cardiology, Hematology, Endocrinology Nephrology,

Elizabeth  Hart, MD

Panelist

Elizabeth Hart, MD

FDA, United States

Branch Chief, General Medicine 1, OTAT, CBER

Janet  Maynard, MD, MHS

Panelist

Janet Maynard, MD, MHS

FDA, United States

Director, Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine

Kelly  Robinson, MSc

Panelist

Kelly Robinson, MSc

Health Canada, Canada

Director General, Marketed Health Products Directorate

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