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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Agenda

Day 1 Sep 08, 2026

8:30 AM — 9:00 AM

Registration

9:00 AM — 9:15 AM

Welcome

9:15 AM — 10:20 AM

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

10:20 AM — 10:50 AM

Coffee Break

10:50 AM — 12:05 PM

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

12:05 PM — 1:05 PM

Lunch break

1:05 PM — 1:50 PM

Signal Detection in Pregnancy and Evidence Generation in Breastfeeding

1:50 PM — 2:40 PM

Industry approaches in pre- and post-authorisation data generation

2:40 PM — 3:40 PM

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

3:40 PM — 4:00 PM

Coffee break

4:00 PM — 4:40 PM

What’s New: PASS and Risk Management Plan Updates

4:40 PM — 5:00 PM

Wrap-up and take home messages

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EMA Risk Management Information Day

Agenda

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