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Session 3: Definitions of Drug Safety
Session Chair(s)
Jill W. Buckley, PHARMD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, United States
This session will clarify important concepts, terms and definitions used in clinical trial and postmarketing drug safety. International consensus terms and definitions will be discussed, particularly those relevant to the US and EU including:
- Key medical product safety terms
- Adverse event versus adverse reaction
- Terms relating to clinical trials and product safety processes
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