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Regulatory Affairs: Part I: The IND Phase and Part II: The NDA Phase

9 - 12 January 2011, Irvine, United States


Introduction
Learn how to apply regulatory concepts to ensure compliant IND submissions to the FDA. Gain insight into the regulatory background of the NDA, preparing an NDA, and postapproval activities. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics

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Venue
University of Southern California

University of Southern California, Irvine, 92612-1308, United States

Organised by
DIA
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