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University of Southern California

2016 年 03 月 13 日 7:30 上午 - 2016 年 03 月 16 日 5:00 下午

Center for the Health Professionals, 1540 Alcazar Street #140, Los Angeles, CA 90089

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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