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Hilton Baltimore Inner Harbor

Jan 27, 2025 7:30 AM - Jan 29, 2025 12:45 PM

401 W Pratt Street, Baltimore, MD 21201, USA

Global Pharmacovigilance and Risk Management Strategies Conference

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

Advance Rates End

DAYS

HOURS

MINUTES

SECONDS

Session 4: Europe and United Kingdom: Regulatory Updates on Policies and Guidances

Session Chair(s)

Stephanie  Millican, PhD, MSc

Stephanie Millican, PhD, MSc

Head of Immunology, Biocompatibility and Non-clinical, 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 :
  • Discuss 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, focusing on their impact on current practices

Speaker(s)

Representative Invited

GVP Guideline

Representative Invited

European Medicines Agency, Netherlands

Priya  Bahri, PhD, RPh

GVP Guideline

Priya Bahri, PhD, RPh

European Medicines Agency, Netherlands

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)

Elspeth  McIntosh, MBA, RN

QPPVs

Elspeth McIntosh, MBA, RN

Castle Pharmacovigilance Ltd, United Kingdom

Director

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