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SESSION 11: REPORTING ADVERSE EVENTS (AES) DURING CLINICAL TRIALS
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
- Definitions of terms
- IND safety reports
- IND annual reports - Safety information/DSUR
- Termination of studies for safety reasons
Speaker(s)
REPORTING ADVERSE EVENTS (AES) DURING CLINICAL TRIALS
Michael Hamrell, PhD, RAC
MORIAH Consultants, United States
President
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