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Baltimore Marriott Waterfront

05 feb 2024 7:00 a.m. - 07 feb 2024 1:00 p.m.

700 Aliceanna Street , Baltimore, MD 21202

Global Pharmacovigilance and Risk Management Strategies Conference

Register for 2 or more short courses and save $150 off your registration fee!

Session 3: Updates on Policies, Guidances, and Regulations – Europe

Session Chair(s)

Sarah  Vaughan

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)

Emil Andrei  Cochino, MD, MHS

Speaker

Emil Andrei Cochino, MD, MHS

European Medicines Agency, Netherlands

Scientific Senior Specialist (Risk Management)

Georgy  Genov, MD

Panelist – Virtual

Georgy Genov, MD

European Medicines Agency, Netherlands

Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department

Phil  Tregunno

Speaker

Phil Tregunno

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Deputy Director - Patient Safety Monitoring

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