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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.

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Session 4: The IND in Detail - Modules 4, 5, and 2

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

  • IND Item 8: Nonclinical Pharmacology and Toxicology
  • IND Item 9: Previous Human Experience
  • IND Item 10: Additional Information

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