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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).

Signal Detection in Pregnancy and Evidence Generation in Breastfeeding

Session Chair(s)

Eva  Jirsova, DrMed

Eva Jirsova, DrMed

Pharmacovigilance Assesor, State Institute For Drug Control, Czech Republic

Robert  Massouh, MPHARM, RPH

Robert Massouh, MPHARM, RPH

Head of Safety (PV) Risk Management and Benefit/Risk Evaluation, GSK, United Kingdom

Speaker(s)

Eva  Jirsova, DrMed

Eva Jirsova, DrMed

Pharmacovigilance Assesor, State Institute For Drug Control, Czech Republic

Breastfeeding Considerations – Evidence Generation and Risk Communication

Cosimo  Zaccaria

Cosimo Zaccaria

Senior PhV specialist, European Medicines Agency, Netherlands

Signal Detection Algorithms in Pregnancy-Related Safety

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