EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)

EMEA-002744-PIP01-19-M01

Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0038/2024

EMEA-002734-PIP01-19-M01

Opinion/decision on a Paediatric investigation plan (PIP): Exparel liposomal, bupivacaine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pain, PIP number: P/0021/2024

Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0037/2024

Human medicines European public assessment report (EPAR): Seladelpar Gilead, Seladelpar lysine dihydrate, Revision: 1, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Blood and lymphatic system disorders, PIP number: P/0040/2024

PhV non-compliance notification contact points at National Competent Authority (NCA) level

EMA establishes regular procedure for scientific advice on certain high-risk medical devices