'The Winding Road from a Brilliant Idea to Drug Approval: An Online Course in Regulatory Science for Academic Researchers' – Publication of Course Material
The STARS consortium organised in February 2021 a 4-day online training for academia covering topics on basic regulatory knowledge and specific regulatory requirements.
The background of this course was to transfer a best-practice example of a support activity for academia in the EU, identified by the respective STARS surveys, to another European Economic Area (EEA) state. This led to the design of an online training course in regulatory science specifically for academic researchers. The course presentations are now available for download. This course represents Pilot I and is one of three STARS pilots foreseen by the EC funded consortium.
The slides represent a valuable source of information for academic researchers who are involved in basic research, drug development, non-clinical studies and clinical trials. The intention is to enhance the knowledge on the regulatory system in the EU in general and on regulatory requirements in specific. Also, information is presented about regulatory tools and support offers for academia by different sources.