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Pharmacovigilance and Risk Management Strategies Conference

Session 8: Reference Safety Information Use in Clinical Trials

Session Chair(s)

Stephen  Knowles, MD, MRCP

Stephen Knowles, MD, MRCP

  • Chief Medical Officer
  • Halozyme Therapeutics, United States
Michael  Richardson, MD, FFPM

Michael Richardson, MD, FFPM

  • International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
  • 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


Andrea  Best, DO, MPH


Andrea Best, DO, MPH

  • Executive Medical Director
  • AbbVie, Inc., United States
Elena  Prokofyeva, MD, PhD, MPH

Status of the CTFG Q&A-RSI Implementation From a Regulatory Prospective

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