The programme has established a Multi-stakeholder platform (MSP), which functions 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 provides 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 full composition is available on the page MSP AG members
- Agenda
- Meeting highlights
- Presentation - Pre-read - Update on the Focus Group on Risk-based approaches -E.Stahl (CTCG)
- Presentation - Pre-read - Update on Patient involvement project and on all ongoing actions identified last year, including RMS, RFI and AxMP - M.Lunzer (CTCG) - M.Al (CTCG)
- Presentation - Pre-read - Update on the outcomes of Paediatric workshop - D.Karres (EMA)
- Presentation- Pre-read - Update on ACT EU progress - L.Pioppo (EMA)
- Presentation - Cross-border clinical trials and arrangements to take part in a trial abroad - F.Houyez (EURORODIS) - I.Klingmann (EFGCP)
- Presentation- Core Dossier - opportunities for increasing efficiency and future proofing the CT ecosystem in Europe -M.OKane (EFPIA)
- Presentation - Reducing review timelines to 60 days - enhancing competitiveness through faster CTA approval - Blanca Garcia Ochoa (EuropaBio)
- Presentation - Proposals on content for ACT EU Clinical trials curriculum - A.Michon (ECRIN)
- Presentation - PA11 Regulatory flexibility for CTs during Public health - G.Capone (EMA) - C.Mihaescu (EMA)
- Presentation - Update on policy development at the EU level - E.Szepessy (EC)
- Presentation - Update on EU clinical trials metrics - L.Pioppo (EMA)
- Agenda
- Meeting highlights
- Presentation - Pre-read - Updates from ACT EU and partners
- Presentation - Presentation on LICT_flexible safety reporting - T.El-Galaly (EHA)
- Presentation - Presentation on OECD framework - J.Demotes (ECRIN)
- Presentation -Update on revision of the March 2024 Recommendation paper on the use of Auxiliary Medicinal Products in Clinical Trials - M.Al (CTCG)
- Presentation - Update on EMA Emergency Task Force (ETF) - M. Mura (EMA)
- Presentation - Update from ACT EU Priority Action on Clinical Trials in PHEs - M.Cavaleri (EMA) - M.Al (CTCG) - I.Clamou (EC)
- Presentation - Pilot programmes for innovative designs and copartnership models - D.Bonifazi (TEDDY)
- Presentation - Update on upcoming ACT EU workshop on external controls - I.Rondak (EMA)
- Presentation - Update on policy development at the EU level - E.Szepessy (EC) - R.Escobar (EC)
- Presentation -Update on patient involvement project- M.Lunzer (CTCG)
- Agenda
- Meeting highlights
- Presentation - Monitoring the EU clinical trials environment - J. van Wyk (EMA)
- Presentation - Revised ACT EU workplan - L. Pioppo (EMA)
- Presentation - Update on EMA Emergency Task Force (ETF) - M. Mura (EMA)
- Presentation - Preparation of request for information and strengthening the role of RMS - C. Temple (CTCG)
- Presentation - COMBINE programme progress report - I. Clamou (EC)
- Presentation - Re-design of CTIS supporting materials - R. Spulber (EMA)
- Presentation - Overview of 2025 events - O. Ademi (EMA)
- Presentation - Survey on SME and academia training needs - E.Psarelli (EMA)
- Presentation - Overview of ICH E6 R3 renovation - P. Twomey (EMA)
- Agenda
- Meeting highlights
- Presentation - MSP AG report on the most frequently reported and major issues -D.Lacombe (EORTC), A. Zanoletty (EMA), T. El-Galaly (EHA)
- Presentation - Report from CTR Collaborate stakeholder meeting held on 11 September - M.Lunzer (CTCG)
- Presentation - Discussion on stakeholder priorities to advise ACT EU Steering Group - A.Zanoletty (EMA), L.Pioppo (EMA)
- Presentation - Approach to consulting academic stakeholders - A.Zanoletty (EMA)
- Presentation - New CTIS Public Portal functionality -F.Scotti (EMA)
- Presentation - Short, medium, long term actions proposed by Industry trade associations
- Agenda
- Meeting highlights
- Presentation - ACT EU workplan and deliverables - A. Zanoletty (EMA), L. Pioppo (EMA)
- Presentation - Paediatric patients involvement in the drug development - B. Nafria (eYPAGnet)
- Presentation - Low-intervention clinical trials - S. Kromar (EORTC)
- Presentation - Limited Scientific advice for academic developers - D. Coppens (KWF)
- Presentation - Innovative Study Designs in Paediatrics - D. Bonifazi (TEDDY)
- Presentation - Enhancing and harmonizing Regulatory process for clinical trials- M. Heath (Vaccines Europe)
- Presentation - Enabling CTIS Public Data Use - F. Sweeney (CDDF)
- Presentation - CTA review process and CTR implementation - L. Leyens (EFPIA)
- Presentation - Challenges in performing mult-country Investigator Initiated Trials in EU - M. Zuidgeest (UMC Utrecht)
- Presentation - Challenges and possible options when designing a Platform Trial - F. Houyez (EURORDIS)
- Minutes
- Presentation - ACT EU workplan and key priorities: expected contribution from MSP AG - A. Zanoletty (EMA)
- Presentation - Mandate and rules of procedure of the MSP Advisory Group - O. Ademi (EMA)
- Presentation - Conclusions and next steps – forward planning of the meetings - O. Ademi (EMA)
- Agenda
- Minutes
- Table of Actions
- Presentation - ACT EU workplan and key priorities: expected contribution from MSP AG - P. Arlett (EMA)
- Presentation - Mandate and rules of procedure of the MSP Advisory Group - A. Zanoletty (EMA)
- Presentation - Launch of call for expression of interest for stakeholder co-chair - M. Carr (EMA)
- Presentation - Conclusions and next steps – forward planning of the meetings - O. Ademi (EMA)
MSP Advisory Group meetings
For information on upcoming and past meetings of the MSP AG, including meeting materials, see below.
News
New approach brings together clinical trial and ethics expertise to accelerate development of medicines for use ahead of or during emergencies
Following consultation with the Multi-stakeholder platform Advisory Group, new documents have been published to support sponsors in the implementation of the Clinical Trials Regulation (CTR).
The report from the annual Multi-stakeholder platform meeting in October 2024 is now available.
MSP documents
This document outlines the MSP Advisory Group’s mandate and rules of procedures.
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.
A concept paper is available on the importance of engaging stakeholders in all phases of a clinical trial, including trial design, and the objectives, composition, governance and transparency rules for the multi-stakeholder platform.
