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Session 6: Regulatory Updates from the UK & EU
Session Chair(s)
Sarah Vaughan
Head of Vigilance Operations
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
This session will provide pharmacovigilance updates from the UK’s Medicines & Healthcare products Regulatory Agency and the European Medicines Agency. The landscape for pharmacovigilance and medicine regulation is rapidly evolving and a multifaceted approach to safety monitoring is required to meet challenges such as scientific innovation, greater demands on the healthcare system from aging populations and polypharmacy, and increasing data volumes. The two speakers will share their current and upcoming work priorities and key challenges for the Regulatory Agencies in pharmacovigilance and risk management for 2022 and beyond.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the MHRA’s and EMA’s upcoming work priorities in their regulatory role
- Understand the MHRA’s plan and next steps for pharmacogenomics and developing a Yellow Card Biobank
Speaker(s)
Speaker
Sarah Vaughan
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Head of Vigilance Operations
Georgy Genov, MD
European Medicines Agency, Netherlands
Head of Pharmacovigilance Office