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Regulatory Affairs Part 1: The IND Phase and Part II: The NDA Phase

14 - 17 March 2011, Horsham, 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.

Event Code:
11436

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Venue
Drug Information Association, Inc.

Drug Information Association, Inc., Horsham, 19044, United States

Organised by
DIA
Contact information
Susan Mazak
215.442.6183
Contact us by email
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