Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines

Third European Medicines Agency and Affordable Medicines Europe bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 10 April 2024

Human medicines European public assessment report (EPAR): Briumvi, ublituximab, Date of authorisation: 31/05/2023, Revision: 5, Status: Authorised

Sponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23

Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 3, Status: Authorised

Q&A Clinic for IRIS Network users for transitioned regulatory procedures, Online, from 23 May 2024, 11:00 (CEST) to 23 May 2024, 12:00 (CEST)

Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Date of authorisation: 23/03/2015, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Date of authorisation: 20/06/2019, Revision: 9, Status: Authorised

ICH M10 on bioanalytical method validation - Scientific guideline

Plasma master file certificates