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Marriott Wardman Park Hotel

Jan 27, 2020 7:00 AM - Jan 29, 2020 4:15 PM

2660 Woodley Road, NW, , Washington, DC 20008 , USA

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, FRCP

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

Speaker

Andrea Best, DO, MPH

AbbVie, United States

Executive Medical Director

Elena  Prokofyeva, MD, PhD, MPH

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

Elena Prokofyeva, MD, PhD, MPH

Federal Agency for Medicines and Health Products (FAMHP), Belgium

Head of Drug Safety Unit, Department of Research & Development, DG PRE

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