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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Session 2: Europe and United Kingdom Safety Regulatory Updates

Session Chair(s)

Sarah  Vaughan

Sarah Vaughan

Head of Vigilance Operations

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

This session will provide regulatory and pharmacovigilance updates from Europe and the UK regions. We will particularly focus on the implementation of new Clinical Trial regulations in Europe and the UK regions as well as the challenges and opportunities this brings. We will hear from the two regulatory authorities on their current and upcoming work priorities for pharmacovigilance.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe the new clinical trial regulation that came into force in Europe in 2022 and discuss the differences to the previous Clinical Trial Directive
  • Discuss challenges and opportunities for safety reporting from a regulatory perspective
  • Recognize MHRA’s progress on updating clinical trial regulations in the UK and its impact on pharmacovigilance activities


Irina  Caplanusi, MD, MSc


Irina Caplanusi, MD, MSc

European Medicines Agency, Netherlands

Signal Management Lead, Pharmacovigilance Department

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