STARS Activities

The work plan includes the development of the Comprehensive Inventory of existing support activities based on an analysis of the survey results. 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 to

  1. transfer an identified best practice example for training programs to other European Economic Area (EEA) countries,
  2. develop a new support activity addressing a gap in regulatory knowledge of significant relevance and
  3. implement the Comprehensive Curriculum.

The project has delivered consensual recommendations ensuring sustainable support of academic research and will propose additional 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 and research projects. A further objective is to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualification.

From 2019 to 2022, STARS has

  1. implemented a comprehensive inventory of existing support activities for regulatory scientific advice and protocol assistance in Europe;
  2. expanded the establishment of best practice examples to facilitate efficient support activities and training programmes, and also provided specific advice and support for the establishment of tailored activities to address the identified gaps;
  3. established a common strategy to strengthen regulatory sciences and improve the support for successful outcomes from regulatory scientific advice, which were agreed and implemented by the partners of the STARS project.
  4. explored and monitored the implementation of a pre-grant regulatory scientific advice on the level of participating Member State also, in order to address the identified need to complement, coordinate and harmonise the national and European efforts.