New clinical trials regulation targeted for early phase trials
| Authors | |
|---|---|
| Year of publication | 2023 |
| Type | Workshop |
| MU Faculty or unit | |
| Citation | |
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| Description | The new Clinical Trials Regulation was implemented on January 31st 2023. What changes has the regulation brought, and which are related to the early-phase trials? Each application for a clinical trial with medicinal products in humans has to be applied through a new Clinical Trial Information System (CTIS). The first experience will be presented. What are the pitfalls of transferring research to the clinical evaluation phase? The SPARK network offers educational events in the field of translational research and so-called transferable skills to their member institutions. It covers topics such as Design Thinking, Addressing Clinical Need, Target product Profile, Project and process management, IP Strategies for Inventions in Biotech, Regulatory Aspects, Collaborative Research & Development with Industry, Entrepreneurial mindset, and business thinking. |
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