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.
Regulatory Affairs Part I: The IND Phase and Part II: The NDA Phase
15 - 18 November 2010, Horsham, United States
Introduction
Venue
Drug Information Association, Inc.
Drug Information Association, Inc., 800 Enterprise Rd Ste 200, Horsham, 19044, United States
Organised by
DIA
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