Module 5 Presentations

16/07/2024

Expected future developments: project on interplay of regulations and IT system deployment

M-GB-00018492 Date of preparation: July 2024

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The COMBINE project - EU

Member States' competent authorities for clinical trials and medical devices and the European Commission launched this project in June 2023.

The COMBINE project aims to analyse the root causes of the challenges encountered by sponsors in conducting combined studies and identify possible solutions to these challenges. combined studies can be understood as studies that involve:

● A clinical trial of a medicinal product in parallel with a performance study of an in vitro diagnostic ● A clinical trial of a medicinal product in parallel with a clinical investigation of a medical device

The project involves representatives of competent authorities, the European Commission, medical research ethics committees, the European Medicines Agency and relevant medicinal product and medical device sector stakeholders.

The project completed its first phase with the publication of the analysis report which includes proposals for possible solutions to address the most important issues. The next steps of this project will involve developing some of the solutions.

● COMBINE Analysis Phase report

M-GB-00018492 Date of preparation: July 2024

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