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Session 4: Europe and United Kingdom: Regulatory Updates on Policies and Guidances
Session Chair(s)
Stephanie Millican, PHD, MSC
Deputy Director Benefit Risk Evaluation, Safety and Surveillance, MHRA, United Kingdom
This session will provide the latest updates on pharmacovigilance and risk management in Europe and the United Kingdom, with an emphasis on navigating local regulatory requirements in these rapidly changing landscapes. Key topics will include MHRA’s new pharmacovigilance guidance following the Windsor Framework agreement, changes to GVP Module XVI Rev III and its appendix on effectiveness measurement, and the introduction of CIOMS XII guidelines on benefit-risk assessment. The speakers will also discuss how these updates are set to drive improvements in benefit-risk planning and management, particularly through enhanced cross-functional collaboration and early-stage planning.
Learning Objective : - Examine MHRA's new pharmacovigilance guidance following the Windsor Framework agreement and its implications for compliance and risk management
- Identify updates to GVP Module XVI Rev III and its appendix on effectiveness measurement and their impact on current practices
Speaker(s)
Priya Bahri, PHD
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
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