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Pharmacovigilance and Risk Management Strategies Conference
Session 9: Reference Safety Information Use in Clinical Trials
Michael Richardson, MD, FFPM
- International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
- 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
Identification and Implementation of Reference Safety Information
Krisztina L. Debreczeni, MD
- Senior Director, Medical Safety Review, Global Pharmacovigilance
- Bristol-Myers Squibb Co., United States
Reference Safety Information (RSI) In the Clinical Trial Setting Current Landscape
Andrea Best, DO, MPH
- Executive Medical Director
- AbbVie, Inc., United States