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.
Regulatory I: The IND Phase
15 - 17 September 2008, Philadelphia, PA, United States
Introduction
Venue
Park Hyatt Philadelphia at the Bellevue
Park Hyatt Philadelphia at the Bellevue, Broad and Walnut Streets, Philadelphia, PA, 19102, United States
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Organised by
Drug Information Association
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