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Session 9: Reference Safety Information Use in Clinical Trials
Session Chair(s)
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety
Bristol-Myers Squibb, United Kingdom
Stephen Knowles, MD, MRCP
Chief Medical Officer
Halozyme Therapeutics, United States
The regulatory expectations in Europe on the use of the RSI to assess expectedness in clinical trial cases has led to challenges for companies to implement the guidances and has led to critical and major findings in EMA regulatory inspections. The updated Clinical Trial Facilitation Group Q&A will be reviewed along with publicly available inspection findings. This will be followed by a review of the challenges for PV departments and examples of good practice.
Learning Objective : Upon completion of this session, the participant 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)
Identification and Implementation of Reference Safety Information
Krisztina L. Debreczeni, MD
Bristol Myers Squibb Co., United States
Head, Medical Safety Review and Expedited Safety Reporting
Reference Safety Information (RSI) In the Clinical Trial Setting Current Landscape
Andrea Best, DO, MPH
Gilead Sciences, United States
Vice President and Head of Patient Safety