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 P.III: Pregnancy and Breastfeeding – Data Collection, Regulatory Expectations and Early Experience

Session Chair(s)

Priya Bahri, PhD

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

Speaker(s)

GVP P.III – Key Concepts and Practical Implications for Pregnancy and Breastfeeding

Viola Macolic Sarinic, DRSc, MD, MSc

Scientific Officer, European Medicines Agency, Netherlands

PRAC Perspective – Expectations, Early Experience and Good Practices

Ulla Wändel Liminga, DrMed, MS, RPh

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

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