1st European Stakeholder Workshop

The focus of the workshop was on the dialogue between clinical researchers and experts from the innovation and health care environment, to learn from each other, to share experiences and needs in order to further improve the knowledge and success of academic driven health research. The results are to be integrated into the STARS Common Strategy, which is the roadmap to strengthening regulatory science and which is aimed to improve the support to enhance successful outcomes of scientific advice and protocol assistance.

During breakout sessions, the workshop groups discussed their perspectives and shared their experiences with the aim to identify measures and actions that lead to an improvement of regulatory support for academia. These included the need for a continious regulatory training on national level in a harmonized matter for medical and life science students up to advance career levels. Another major point of discussion was the communication and that communication needs to be improved for both academics and regulators as well as for all relevant stakeholders, in order to find the same language again. It is necessary to have an open-minded dialogue and to become aware that the communication is bidirectional. Further, the demand of funding for regulatory (pre-grant) advice and the problem of the adequate timing to get the funding should be in the focus of a future strategy. The discussion points highlighted that the gaps identified by the STARS activities so far (see STARS Surveys) are the “right ones” that will be addressed with the STARS initiatives like the Comprehensive Curriculum and further pilot milestones like the STARS Pilots.