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European Medicines Agency

Sep 08, 2026 8:30 AM - Sep 08, 2026 5:00 PM

Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands

EMA Risk Management Information Day

This in-person information day will provide an overview of key developments in EU pharmacovigilance guidance related to the safe use of medicines during pregnancy and breastfeeding as well as updates in GVP Module V Risk Management Plans and GVP Module VIII Post authorisation safety studies (PASS).

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Send Email +41 61 225 5151

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What’s New: PASS and Risk Management Plan Updates

Session Chair(s)

Priya Bahri, PhD

Priya Bahri, PhD

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

Speaker(s)

Catherine Cohet, PhD

Catherine Cohet, PhD

Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

GVP Module VIII (PASS) Revision and ICH M14 Implementation

Emil Andrei Cochino, MD, MHS

Emil Andrei Cochino, MD, MHS

Scientific Senior Specialist (Risk Management), European Medicines Agency, Netherlands

GVP Module V – Updates to Risk Management Plans: Forward-Looking Regulatory Developments

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