DIA EUROPE 2021

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. However, academic researchers are key drivers in research on innovative therapy approaches. The EU-funded Coordination and Support Action STARS (Strengthening Training of Academia in Regulatory Sciences, www.csa-stars.eu) aims to improve the direct regulatory impact of results obtained in medical research. 18 European countries and EMA are represented in the consortium through their national competent authorities, alongside with academic and industry representatives, and associations with relevant experience. STARS has the objective and the potential to complement, coordinate and harmonise regulatory efforts, especially interaction and communication, 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. How this can be achieved, what can be learned from individual networks, initiatives and activities, will be discussed with experts in the field of (clinical) research and the regulatory network.