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Helpdesk for non-commercial sponsors: 6-month report
Meeting highlights MSP Advisory Group 18 September 2025
Hlavné témy
ACT EU workshop on paediatric clinical trials report
Report to monitor the European clinical trials environment (July - September 2025)
Hlavné témy
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
