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The Westin Boston Waterfront

Aug 13, 2018 7:45 AM - Aug 16, 2018 5:00 PM

425 Summer Street, Boston, MA 02210

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 19: Post NDA Approval Regulatory Requirements

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

  • Post NDA Approval Obligations
  • Post-Marketing Requirements and Commitments
  • Supplements and Other Changes to an Approved Application
  • Post-Marketing Reporting
  • NDA Annual Reports
  • Other Post-Marketing Reports

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