A top orphan drugs official from the federal Food and Drug Administration will discuss his office's recent regulatory developments in a 90-minute Webcast that can be viewed free Jan. 16, from 10:30 a.m. until noon at the Biotechnology Center
The shared Webcast viewing will feature Timothy Cote, M.D., M.P.H., director of the FDA Office of Orphan Products Development (OOPD) in a general overview of his office and the Orphan Products Program. FDA experts will also discuss the "Orphan" designation, The Orphan Drug Act and the OOPD Grants Program. An update on FDA's recent developments for Orphan Drugs & Humanitarian Use Devices and their implications will be followed by a Q&A session.
The event, to be held in the Congressional Room at the Biotechnology Center, 15 T.W. Alexander Drive in Research Triangle Park, targets several key messages for participants. They should leave the session more confident in summarizing the Orphan Drug Act and its incentives for developing and marketing drugs, biologics, medical devices or medical foods for rare diseases; informed about the OOPD grant program, which encourages clinical development of products for use in rare diseases or conditions; and armed with helpful hints for submitting an application for "orphan" designation.
The event, co-sponsored by the Biotechnology Center and the North Carolina Regulatory Affairs Forum (NCRAF) is the latest in a series of educational Webcasts developed by the Regulatory Affairs Professionals Society (RAPS).
Registration is free and open to all, though professionals from industry, regulatory agencies, academic and research institutions are especially encouraged to participate. Seating is limited, so please RSVP on-line at www.ncraf.org (NCRAF membership is not required). Participants are also encouraged to carpool to save energy and prevent parking woes.