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Session 3: IND in Detail - Modules 3 and 1
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
- IND Item 7: Chemistry, Manufacturing, and Controls
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Sheraton Philadelphia University City
14 oct 2019 7:45 a.m. - 17 oct 2019 5:00 p.m.
3549 Chestnut Street, Philadelphia, PA 19104
Regulatory Affairs: The IND, NDA, and Post-Marketing
Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.