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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GVP Module XVI Addendum I: Deep Dive into Embryo–Fetal Risk Minimisation and Early Experience

Session Chair(s)

Viola Macolic Sarinic, DRSc, MD, MSc

Scientific Officer, European Medicines Agency, Netherlands

Speaker(s)

Addendum I – Regulatory Rationale, Implementation Reflections and Learning from Experience

Priya Bahri, PhD

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

Addendum I – Regulatory Rationale, Implementation Reflections and Learning from Experience

Liana Martirosyan, DrMed

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

Industry Perspective – A Qualitative study to investigate Risk Minimisation Effectiveness Barriers in Women Of ChildBearing Potential (WOCBP)

Mathieu Lamy, MPH

Director Pharmacoepidemiologist, Sanofi, Belgium

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