The three-year project will be coordinated by the two German regulatory authorities – the Federal Institute for Drugs and Medical Devices, BfArM and the Paul-Ehrlich Institute, PEI. Its activities will be supported by the DLR Projektträger (DLR-PT), one of Germany’s largest service providers for the funding of research and innovation. The consortium comprises authorities from 18 European countries and is funded by the European Commission with around EUR 2 million.
Background
Improving the regulatory knowledge of academic health researchers will strongly increase the impact of their results and findings for patients and health care systems. One way to achieve this is to improve professional education and provide targeted training programmes. In addition, stipulating academia in regularly asking for scientific advice and continuous protocol assistance in clinical development projects will strengthen successful outcomes and enhance the impact of academic health research for the benefit of the patients.
Objectives
STARS will coordinate efforts between the national authorities and European partners, relevant initiatives and stakeholders as well as the academic research community, both on the national and the European level. It thus intends to improve the direct regulatory impact of results obtained in medical research.In the upcoming three years, STARS will
- Establish a comprehensive inventory of existing support activities for regulatory scientific advice and protocol assistance in Europe.
- Expand the establishment of best practice examples for efficient support activities and training programmes. It also will provide specific advice and support for the establishment of tailored activities and address the identified gaps.
- Establish a common strategy to strengthen regulatory sciences and improve the support for successful outcomes from regulatory scientific advice, which will be agreed and implemented by the partners of the STARS project.
- Explore and monitor the implementation of a pre-grant regulatory scientific advice on the level of participating Member States. In order to address the identified need to complement, it also will coordinate and harmonize the national and European efforts.
