Drug Information Association, Park Hyatt Philadelphia at the Bellevue, Philadelphia, PA, USA
Sep 15 2008
This course will offer insight into the regulatory background of the IND and outline the content and data requirements for an IND submission to FDA. The course will focus on drug and well-characterized biological products and not the regulatory process for devices, generic products or traditional biologics.
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Invited Speakers:
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Karen K. Church, PhD Vice President, Regulatory Affairs Ocera Therapeutics, Inc.United States. Carol H Danielson, PhD, MA, MS PresidentRegulatory Advantage United States. Cynthia L. Kirk, PhD Vice President, Regulatory Affairs K V Pharmaceuticals United States.
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