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Strengthening training of academia in regulatory sciences and supporting regulatory scientific advice (STARS)

Project description

Training to push faster innovation in medicine

Research institutions are currently working on numerous disruptive medicine innovations. However, regulatory-related barriers and lack of new treatment paradigms in academia delay the impact of such research. This prevents patients from benefiting from the latest developments. The EU-funded STARS project proposes to analyse and improve the European level of professional education in health training of academics in the field of regulatory science. Through the creation of a common strategy strengthening regulatory sciences, as well as establishing a core curriculum for professional training of clinical scientists and a comprehensive curriculum for specific post-graduate programmes, the project will enable faster dissemination and availability of cutting-edge treatments across Europe.


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 aims to improve the direct regulatory impact of results obtained in medical research. Seventeen European countries are represented in the consortium through their national competent authorities, alongside academic and industry representatives, and associations with relevant experience.
The work plan includes the development of a Comprehensive Inventory of existing support activities based on a detailed analysis of the currently established programmes. This analysis is 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 aim (i) to transfer an identified best practice example for training programmes to other EEA countries, (ii) to implement a new support activity addressing a gap in regulatory knowledge of significant relevance and (iii) to implement the Comprehensive Curriculum. STARS will deliver consensual recommendations ensuring sustainable support of academic research and will propose additional support mechanisms based on a comprehensive analysis of needs.
STARS has the objective and the potential 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 is to reach academic researchers very early in the planning of relevant grant applications. A further aim is to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualification.

Call for proposal


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Sub call



Net EU contribution
€ 190 000,00
Kurt georg kiesinger allee 3
53175 Bonn

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Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt
Other funding
€ 0,00

Participants (20)