The programme aims to establish a Multi-stakeholder platform (MSP), which will function as a vehicle for clinical trials stakeholders and regulators to come together, voice their views and collaborate to improve the clinical trials environment for European patients and citizens.
The MSP will provide the opportunity for stakeholders to exchange views and enable dialogue with regulators through:
1. the creation of a MSP Advisory Group;
2. multi-stakeholder events;
3. consultations, surveys, and other tools to gather stakeholders' feedback.
MSP Advisory Group
The MSP Advisory Group (MSP AG) is composed of representatives from key stakeholders who provide:
- strategic advice regarding the ACT EU workplan, identifying stakeholder priorities;
- operational advice for ACT EU initiatives, identifying experts and engagement methodology.
The summary report of the first ACT EU MSP workshop held in June 2023, to understand different stakeholder perspectives on how to transform the EU environment for clinical trials, discuss the feedback from the MSP public consultation and agree on a model for the establishment of the MSP.
The report on the outcome of a public consultation where the European Medicines Agency invited stakeholders to provide input on the ACT EU MSP concept paper, priority topics for the MSP and to express their interest in participating.