(0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Sheraton Philadelphia University City

Oct 14, 2019 7:45 AM - Oct 17, 2019 5:00 PM

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.

Back to Agenda

Session 5: The IND in Detail - Additional Topics

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

  • Additional Requirements for Biologics and Biotechnology-Derived Products
  • Submission of an Initial IND

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.