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Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!

Session 9: Reference Safety Information Use in Clinical Trials

Session Chair(s)

Michael  Richardson, MD, FFPM, FRCP

Michael Richardson, MD, FFPM, FRCP

  • Senior Vice President, WorldWide Patient Safety
  • Bristol-Myers Squibb, United Kingdom
Stephen  Knowles, MD, MRCP

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


Krisztina L. Debreczeni, MD

Identification and Implementation of Reference Safety Information

Krisztina L. Debreczeni, MD

  • Head, Medical Safety Review and Expedited Safety Reporting
  • Bristol Myers Squibb Co., United States
Andrea  Best, DO, MPH

Reference Safety Information (RSI) In the Clinical Trial Setting Current Landscape

Andrea Best, DO, MPH

  • Executive Medical Director
  • AbbVie, Inc., United States