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Session 8: Reference Safety Information Use in Clinical Trials
Session Chair(s)
Stephen Knowles, MD, MRCP
Chief Medical Officer, Halozyme Therapeutics, United States
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety , Bristol-Myers Squibb, United Kingdom
The regulatory expectations in Europe on the use of the RSI to assess expectedness in clinical trial cases has led to challenges for companies in implementing the guidance on the RSI and has led to critical and major findings in EMA regulatory inspections. Regulatory guidance, including updates to previous guidance, and examples of inspection findings will be presented.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the requirements for the use of the RSI in clinical trials
- Understand how the requirements are enforced by regulatory agencies
- Learn some approaches that have been successful
Speaker(s)
Andrea Best, DO, MPH
Vice President and Head of Patient Safety, Gilead Sciences, United States
Speaker
Elena Prokofyeva, MD, PHD, MPH
Head of Drug Safety Unit, Department of Research & Development, DG PRE, Federal Agency for Medicines and Health Products (FAMHP), Belgium
Status of the CTFG Q&A-RSI Implementation From a Regulatory Prospective