Regulatory Affairs: The IND, NDA, and Postmarketing

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Regulatory Affairs: The IND, NDA, and Postmarketing
Date 2016-11-22
Place Aug 15 - 18, 2015 ,Boston, Massachusetts United States Of America

Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of lectures, workshops and online precourse modules. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics. [1]


DIA, a non-profit association, was founded in 1964 as a neutral global membership association dedicated to improving communication and collaboration in drug development. That goal remains the same today.

The organization was born out of a true need. DIA’s founding was closely tied to the 1962 passage of sweeping legislation passed in the United States in response to the finding that use of thalidomide to treat morning sickness caused birth defects. Although the problem was global, there was no organization at the time that could foster cooperative efforts across the entire world. Seeing the need, a group of 30 pharmaceutical professionals, medical writers, and academics created DIA as a fully independent, unbiased, non-profit association.

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