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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.

Session 2: The IND in Detail - Modules 1, 2, and 5

Session Chair(s)

Drusilla  Scott, PHD, RAC

Drusilla Scott, PHD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., United States

  • IND Item 1: Form FDA 1571
  • IND Item 2: Table of Contents
  • IND Item 3: Introductory Statement
  • IND Item 4: General Investigation Plan
  • IND Item 5: Investigator’s Brochure
  • IND Item 6: Protocols

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