New CORS Research Project for Regulatory Data Collection and Analytics

This project aims at exploring the feasibility, sustainability and usability of creating and maintaining a regulatory science database, that collects in a (semi-) automated manner unstructured data from publicly available regulatory resources and transforms them in structured data ready to be sequentially analysed. The database will support the development of both a publicly available user interface to conduct (near) real-time descriptive analytics of regulatory process and output indicators, and an updated database for hypothesis-driven regulatory science studies in the functioning of the regulatory system.

The pilot project will focus on two use cases: Characteristics and follow-up of agreed Pediatric investigation plans in the EU; and description and follow-up of medicine-related safety issues evaluated in Pharmacovigilance Risk Assessment Committee (PRAC) – mapping PRAC safety evaluation process. The two use cases allow the exploration of two different phases of the drug life-cycle. This pilot project will provide a proof of concept for the creation of a regulatory science database.  The intent is to further expand the database to include additional regulatory domains as well as additional regulatory regions. Overall, the goal is for the database to provide a basis for regulatory science studies, that can improve our understanding of whether regulatory instruments are having their intended impact and can help identify areas for improvement.

The project is funded by CORS in partnership with Novo Nordisk A/S.