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Session 3: IND in Detail - Modules 3 and 1
Session Chair(s)
Drusilla Scott, PHD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
- IND Item 7: Chemistry, Manufacturing, and Controls
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Seaport Hotel
12 ago 2019 7:45 a.m. - 15 ago 2019 5:00 p.m.
One Seaport Lane, Boston, MA 02210
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.