Update on the CSA Stars

20 May 2021 – The European Coordination and Support Action STARS (Strengthening Training of Academia in Regulatory Science) aims to improve the direct regulatory impact of results obtained in medical research. Their recent activities include a publication, a training course and an inventory on regulatory affairs.

'The Winding Road from a Brilliant Idea to Drug Approval: An Online Course in Regulatory Science for Academic Researchers'

The STARS consortium organised in February 2021 a 4-day online training for academia with topics on basic regulatory knowledge and specific regulatory requirements. The aim of this Pilot I was to transfer a best-practice example of a support activity for academia in the EU to another member state. The best-practice example was identified based on an analysis of the STARS survey data. It revealed that there is an unmet need for a basic training on essential regulatory knowledge for academic researchers. Some STARS partners offer specific training for academics, whereas other countries could have a great benefit from such a course. Thus, STARS partners from the Czech Republic and the Netherlands transferred their course to Austria, Hungary, and Italy. The overall feedback was positive and 94 % of participants would recommend such a course. In particular, the insights given on the regulatory system and framework as well as the regulatory pathways were considered very helpful.

All training presentations are now available. The slides represent a valuable source of information for academic researchers who are involved in basic research, drug development, non-clinical studies and clinical trials.

Find Support in Regulatory Affairs – the STARS Comprehensive Inventory

The purpose of this Comprehensive Inventory (CI) is to assist European academic drug developers in finding support on regulatory affairs. The inventory lists various support services provided by national competent authorities, public actors and private entities. You can browse the data collection by country, expertise area and support scope. Plus: provider profiles can be downloaded in PDF format.

CSA STARS Publication: Strengthening Regulatory Science in Academia

'Strengthening regulatory science in academia: STARS – an EU initiative to bridge the translational gap' is the title of a STARS publication which outlines what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia. Furthermore, it proposes key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities.