The EMA Risk Management Information Day 2026 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).

A central focus will be on the Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk, published on the EMA website since February 2026. The programme will introduce the main concepts of the guideline and facilitate discussion on initial implementation experiences from both industry and regulators.

The event will also explore practical aspects of applying the GVP Addendum I to Module XVI on minimizing embryo–fetal risk, published in August 2025, highlighting early learnings related to the new approach to Pregnancy Prevention Programmes (PPP) and other riskminimisation activities. In addition, participants will receive updates on ongoing EMA initiatives addressing pregnancy-related safety, including work on methodologies and regulatory approaches supporting the translation of evidence from data to product information.

Furthermore, updates to GVP Module V – Risk Management Plans will also be discussed, focusing on upcoming clarifications and expectations relevant to industry and regulators. The programme will also address updates to GVP Module VIII (Post authorisation safety studies (PASS), including new requirements for study protocols, study reports, and feasibility assessments, reflecting recent changes to the PASS guideline introduced through ICH M14 and their European implementation, illustrated with a practical study protocol example.