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Westin Gaslamp Quarter, San Diego

Mar 20, 2017 7:30 AM - Mar 23, 2017 5:00 PM

910 Broadway Circle, , San Diego, CA 92101 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

Session 13: Reporting Adverse Events (AEs) During Clinical Trials

Session Chair(s)

Michael  Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

  • Definitions of Terms
  • IND Safety Reports
  • IND Annual Reports - Safety Information
  • Discontinuation of Studies for Safety Reasons

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