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Session 4: Europe and United Kingdom: Regulatory Updates on Policies and Guidances
Session Chair(s)
Representative Invited
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 : - Discuss MHRA's new pharmacovigilance guidance following the Windsor Framework agreement and its implications for compliance and risk management
- Review the updates to GVP Module XVI Rev III and its appendix on effectiveness measurement, focusing on their impact on current practices
Speaker(s)
GVP Guideline
Representative Invited
European Medicines Agency, Netherlands
Speaker
Priya Bahri, PhD, RPh
European Medicines Agency, Netherlands
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
QPPVs
Representative Invited
Castle Pharmacovigilance Ltd, United Kingdom