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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).

Pregnancy & Breastfeeding Safety: Bridging Regulatory Expectations and Real-World Implementation - panel discussion

Session Chair(s)

Viola  Macolic Sarinic, DRSC, MD, MSC

Viola Macolic Sarinic, DRSC, MD, MSC

Scientific Officer, European Medicines Agency, Netherlands

Speaker(s)

Anna  Beckmeyer-Borowko

Anna Beckmeyer-Borowko

Associate Director Epidemiologist, Novartis Pharma, Switzerland

Eva  Jirsova, DrMed

Eva Jirsova, DrMed

Pharmacovigilance Assesor, State Institute For Drug Control, Czech Republic

Liana  Martirosyan

Liana Martirosyan

PRAC Member and PRAC Vice-Chair, Medicines Evaluation Board (MEB), Netherlands

Marleen  van Gelder

Marleen van Gelder

Assistant Professor in PharmacoEpidemiology, Radboud University Medical Center, Netherlands

Ulla  Wändel Liminga, DrMed, MS, RPH

Ulla Wändel Liminga, DrMed, MS, RPH

Scientific Director Pharmacology/Toxicology, Medical Products Agency (MPA), Sweden

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