Report on the ACT EU Webinar Regarding Contractual Agreements
The report on the ACT EU webinar regarding contractual agreements, held on 16 April, has been published on the ACT EU website. The webinar explored how clinical site agreements affect the start-up of clinical trials and shared national and European experiences on...
[MESSAGE FROM ACT EU – Request for stakeholders’ input on the guideline to simplify the clinical trials application package for use during Public Health Emergencies (PHEs).]
ACT EU has developed the guideline to simplify the clinical trials application package for use during PHEs. The package consists of: 1️⃣ A guidance document on the simplified application package for clinical trials targeting a PHE 2️⃣ Annex I: Part I language...
[ACT EU Workplan for 2026-2027 – Version 4, May 2026]
The ACT EU workplan for 2026 – 2027 has been adopted by the ACT EU Steering Group and is now published. The workplan reflects the revised ACT EU objectives and takes into account recent legislative and policy developments including the proposed Biotech Act, the...
[News from ACT EU] – Clinical Trials Information System (CTIS): training and support
Check out the publication of a new EMA document of frequently asked questions (FAQ) for sponsors on the Clinical Trials Information System (CTIS):...