The European Medicines Agency (EMA) has scheduled a Risk Management Information Day for 8 September 2026, focusing on the operationalisation of new EU Good Pharmacovigilance Practices (GVP) requirements for pregnancy and breastfeeding safety, as well as updates to GVP Modules V and VIII. The event, to be held at EMA's Amsterdam headquarters, targets risk management professionals from small to medium enterprises, patient and healthcare professional representatives, qualified persons for pharmacovigilance, marketing authorisation holders, national competent authority assessors, contract research organisations, and risk communication experts.
The central focus of the information day will be the GVP Product- or Population-Specific Considerations III (P.III) guideline, published in February 2026, which addresses data collection during pregnancy and breastfeeding. Sessions will cover regulatory expectations, early assessment insights, and integration of pregnancy and breastfeeding data into PSURs, RMPs, and signal management. A dedicated session will also explore the GVP Addendum I to Module XVI on minimising embryo-fetal risk, published in August 2025, highlighting early learnings from the new approach to Pregnancy Prevention Programmes (PPP) and other risk-minimisation activities. Industry perspectives will be presented, including a qualitative study by Sanofi on risk minimisation effectiveness barriers in women of childbearing potential.
Updates to GVP Module V (Risk Management Plans) and Module VIII (Post-authorisation safety studies, PASS) will also be discussed. The Module VIII update reflects recent changes introduced through ICH M14 and their European implementation, including new requirements for study protocols, study reports, and feasibility assessments, illustrated with a practical example. The event will feature speakers from EMA, the Pharmacovigilance Risk Assessment Committee (PRAC), national competent authorities, and industry, including Georgy Genov (EMA Head of Pharmacovigilance Office), Ulla Wändel Liminga (PRAC Chair), and representatives from GSK, Sanofi, Novartis, and ViiV Healthcare.
The information day aims to bridge the gap between guidance and practice, facilitating discussion on initial implementation experiences from both regulators and industry. Stakeholders impacted include pharmaceutical companies, which will need to adapt their risk management and pharmacovigilance systems to comply with the new guidelines; national competent authorities, which will assess compliance; healthcare professionals, who may need to adjust prescribing and monitoring practices; and patients, particularly those of childbearing potential, who may benefit from improved safety monitoring and risk communication. The event underscores EMA's ongoing efforts to strengthen the evidence base for regulatory decision-making regarding medicine use during pregnancy and breastfeeding.