Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported by ACT EU

The Clinical Trials Coordination Group (CTCG), supported by the ACT EU Priority Action on Mapping and Governance, invites all stakeholders to the Clinical Trials Regulation (CTR) Collaborate Stakeholder Meeting.

• Date:
  Wednesday, 11 September 2024 , 13:00 - 17:30 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

The Clinical Trials Coordination Group (CTCG), supported by the ACT EU Priority Action on Mapping and Governance, invites all stakeholders to the Clinical Trials Regulation (CTR) Collaborate Stakeholder Meeting. 

The CTR Collaborate initiative started in May 2023 with the aim to foster interaction between NCAs and Ethics in EU/EEA implementing the Clinical Trial Regulation and Implementing Regulation on safety cooperation. This meeting aims to share insights from the CTR Collaborate project and to bring the views of the stakeholders into the project. This stakeholder meeting informs on activities carried out to date, and aims to collect additional stakeholder input. 

Meeting highlights:

• Open session: live-streamed and available without pre-registration. 
  Key topics include:
  • The EU regulatory landscape mapping exercise and the roles of ethics committees in Part I assessment.
  • Identified issues within and across Member States, the role of the Reporting Member State (RMS), and technical CTIS aspects.
  • Proposed solutions, ongoing work on best practices, training, stakeholder interaction, and sharing Member States' experiences.
• Closed session: requires pre-registration and features breakout sessions to delve deeper into the most urgent topics which need a solution. Participants can propose breakout session topics during registration via the survey tool.

Key objectives of CTR Collaborate:

1. Promote health: Advance novel therapeutic strategies and increase clinical trials in the EU/EEA.
2. Ensure safety: Maintain high clinical trial application and assessment standards.
3. Harmonise procedures: Align NCAs and ethics committees across Member States, building trust and a common understanding of CTR and endorsed guidelines.

The meeting offers a platform to discuss improvements and contribute to making the EU/EEA an attractive place to conduct clinical trials. By addressing challenges and collaborating effectively, we aim to build a better future for clinical research.

Documents

Agenda - Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported by ACT EU

Presentation - Session 1: Mapping the landscape (S.Strasser)

Presentation - Session 2: Issue list and proposals for solutions (C.Bahans, E.Stahl, AM.Janson Lang, J.Bryant)

Presentation - CTR collaborate project: Setting the scene (M.Lunzer, M.Al)

Presentation - Break-out session 1: Harmonisation in the EU Clinical Trials Framework (C.Bahans)

Presentation - Break-out session 2: New strategies for streamlining clinical trial review and approval processes (M.Al)

Presentation - Break-out session 3: Fostering innovation in clinical trials (J.Bryant)

Presentation - Break-out session 4: Enhancing CTIS functionality and operational efficiency (S.Strasser)

Video recording