Documents

Report to monitor the European clinical trials environment (July - September 2025)

EU clinical trials during the 3 year CTR transition period

Core Dossier - opportunities for increasing efficiency and future proofing the CT ecosystem in Europe - M.OKane (EFPIA)

Update on EU clinical trials metrics - L.Pioppo (EMA)

Update on policy development at the EU level - E.Szepessy (EC)

Pre-read - Update on ACT EU progress - L.Pioppo (EMA)

Cross-border clinical trials and arrangements to take part in a trial abroad - F.Houyez (EURORODIS) - I.Klingmann (EFGCP)

Proposals on content for ACT EU Clinical trials curriculum - A.Michon (ECRIN)

PA11 Regulatory flexibility for CTs during Public health - G.Capone (EMA) - C.Mihaescu (EMA)

Reducing review timelines to 60 days - enhancing competitiveness through faster CTA approval - Blanca Garcia Ochoa (EuropaBio)

Update on the outcomes of Paediatric workshop - D.Karres (EMA)

Update on Patient involvement project and on all ongoing actions identified last year, including RMS, RFI and AxMP - M.Lunzer (CTCG) - M.Al (CTCG)

Update on the Focus Group on Risk-based approaches -E.Stahl (CTCG)

Agenda MSP Advisory Group meeting 18 September 2025

Meeting highlights - MSP Advisory Group 26 Juen 2025

ACT EU workshop report on ICH E6 R3 principles and annex 1

Annexes of report on clinical trials training needs of academia and SMEs

Report on clinical trials training needs of academia and SMEs

Report to monitor the European clinical trials environment (April - June 2025)

Update on patient involvement project_M.Lunzer (CTCG)