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Session 2: Europe and United Kingdom Safety Regulatory Updates
Session Chair(s)
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
Speaker(s)
Speaker
Irina Caplanusi, MD, MSc
European Medicines Agency, Netherlands
Signal Management Lead, Pharmacovigilance Department
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