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Session 10: Clinical Trial Safety Regulations – EU Clinical Trial Safety Reporting
Session Chair(s)
Jill W. Buckley, PHARMD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, United States
This session will cover the safety reporting requirements in the EU for clinical trials and will include an overview of the requirements in the UK, Canada, as well as Japan.
- Council Directive 2001/20/EC and CT-3
- Definitions
- Expedited Reporting
- Periodic Reporting
- New EU CT Regulation
- Requirements in other selected countries
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