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Session 3: Updates on Policies, Guidances, and Regulations – Europe
Session Chair(s)
Sarah Vaughan
Head of Vigilance Operations
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Representatives from the European Medicines Agency & Medicines & Healthcare products Regulatory Agency will provide regulatory and pharmacovigilance updates from Europe and the UK. We will hear from the two regulatory authorities on their current and upcoming work priorities with a focus on advances in pharmacovigilance and risk management strategies.
Learning Objective : - Describe recent EMA regulatory updates including Good Vigilance Practice guidance updates & its implications for pharmacovigilance activities
- Describe recent MHRA regulatory updates and advances at the MHRA in pharmacovigilance and risk management strategies at the MHRA
- Discuss current challenges and future opportunities for safety reporting from a regulatory perspective
Speaker(s)
Speaker
Emil Andrei Cochino, MD, MHS
European Medicines Agency, Netherlands
Scientific Senior Specialist (Risk Management)
Panelist – Virtual
Georgy Genov, MD
European Medicines Agency, Netherlands
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
Speaker
Phil Tregunno
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director - Patient Safety Monitoring