ACT EU aims to facilitate aligned clinical trial guidance development across the European network resulting in high impact guidance documents implemented in practice.
In order to reach this goal, the objectives of the work will be to:
- ensure mutual awareness of our guidance landscape across European Union (EU) expert groups;
- ensure involvement of all relevant stakeholders at the right time to facilitate alignment, consolidation and implementation of methodology guidance;
- bring together clinical trial authorisation by Member States and down-stream decision makers;
- help our stakeholders navigate the EU clinical trial guidance landscape;
- ensure capturing and sharing of lessons learned.
These objectives ensure that all relevant EU expert groups pool their expertise and align their priorities in order to accelerate the development of future guidance, in collaboration with relevant stakeholders.
Direct deliverables to fulfil these objectives will include:
- a roadmap to clarify the guidance landscape with an overview of the existing, ongoing and planned key guidance activities;
- a methodology workshop to facilitate alignment, consolidation and accelerate guidance development;
- internal best practice on how to develop guidance documents and ensure implementation;
- internal process for coordination of guidance development to ensure sustainable coordination of methodology guidance development.
Related material
Decentralised clinical trials
EMA website: Guidance for decentralised clinical trials
EMA website: Facilitating decentralised clinical trials in the EU
Complex clinical trials
EMA website: Guidance for complex clinical trials
HMA website: CTCG Q&A on submission complex clinical trials in CTIS
Additional topics
