Project name: STARS – Strengthening Training of Academia in Regulatory Science
EU funding scheme: Coordination and Support Actions
Project span: 1 January 2019 - 31 December 2021
BfArM - Federal Institute for Drugs and Medical Devices,
PEI - Federal Institute for Vaccines and Biomedicines,
DLR-PT - Project Management Agency of the German Aerospace Center
Project flyer: download PDF
Limited knowledge in regulatory science delays the development of new treatment strategies or limits the chances that promising innovations will reach patients. STARS aims to analyse the current situation and improve the training of academia in regulatory sciences and thereby further enhance regulatory knowledge.
The overall goals of STARS comprise also strengthening academic, regulatory science on national and European level, as well as improving success in regulatory Scientific Advice and Protocol Assistance of academic driven health research. The vision is to advance the direct regulatory impact of results obtained in medical research by professional education and targeted training programmes for academic scientists. Additional activities, such as support for successful outcomes in scientific advice and protocol assistance in clinical development projects, will enable academic health research to have the full impact and benefit for the patient.
During the 3 years project period, STARS will
- establish a Comprehensive Inventory of existing support activities for academic researchers, in order to improve success during Scientific Advice and Protocol Assistance procedures;
- expand the establishment of best practice examples for efficient Support Activities / training programmes and by providing specific advice and support for the establishment of tailored activities and addressing 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 State also, in order to address the identified need to complement, coordinate and harmonise the national and European efforts.