Risk Management Information Day

This live virtual information day is structured to transition from conceptual discussions to practical applications, focusing on the key themes of GVP Module XVI rev 3.

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Session 2: Case Examples of Practical Application in Local Context, Q&A and wrap-up

Session Chair(s)

Priya Bahri, PHD

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Speaker(s)

Krystyna Cegielska-Perun, PHD

Head of the Unit for the Assessment of Safety Documentation , Office for Registration of Medicinal Products, Poland

A member state’s approach to implementing GVP Module XVI Rev 3 –

Ryan Marshall

Risk Management Director, AstraZeneca, United Kingdom

Localising additional RMM for implementation and decision making across the product lifecycle

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