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Sheraton Philadelphia University City

Oct 22, 2018 1:45 PM - Oct 25, 2018 11:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

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

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Session 11: Reporting Adverse Events (AEs) During Clinical Trials

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

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

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