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Session 13: Reporting Adverse Events (AEs) during Clinical Trials
Session Chair(s)
Drusilla Scott, PHD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
- Definitions of Terms
- IND Safety Reports
- IND Annual Reports - Safety Information
- Discontinuation of Studies for Safety Reasons
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