STARS was the EU funded Coordination and Support Action on Strengthening Training of Academia in Regulatory Science (CSA STARS). The project was concluded on 30 June 2022.

Lack of specific relevant know-how in regulatory science delays the development of new treatment strategies or limits the chances that promising innovations will reach patients. STARS aimed to improve the direct regulatory impact of results obtained in medical research. 18 European countries were represented in the consortium through their national competent authorities, alongside academic and industry representatives, and associations with relevant experience.

The work plan included the development of a Comprehensive Inventory of existing support activities based on a detailed analysis of the currently established programmes. This analysis was also the basis for development of a Common Strategy to strengthen regulatory sciences and two curricula, the Core Curriculum specifying essential knowledge for the professional training of clinical scientists and the Comprehensive Curriculum defining relevant knowledge for specific post-graduate programmes.

Three Pilot Projects aimed to

• transfer an identified best practice example for training programmes to other EEA countries,
• establish a new support activity addressing a gap in regulatory knowledge of significant relevance, and
• implement the Comprehensive Curriculum.

The project delivered recommendations ensuring sustainable support of academic research and proposed additional support mechanisms based on a comprehensive analysis of needs.

STARS had the objective to complement, coordinate and harmonise regulatory efforts among Member States and at European level to support academic health research for the benefit of patients. The aim was to reach academic researchers very early in the planning of relevant grant applications. A further aim was to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualification.