The goal of the Real4Reg project is to improve regulatory processes using real-world data (RWD). Among other things, the project uses information on the use of medicines from health insurance billing data. However, this is a lot of information and is complex. Artificial intelligence is to cope with this and make patterns and predictive models recognizable.

Examples will be used to develop methods for using artificial intelligence in regulatory decisions along the product life cycle of a drug. Another topic will be improving existing processes and introducing new methods to organizations. Ultimately, the aim is to increase the efficacy and safety of medicines in practice.

The project will involve various stakeholders and analyze the challenges and opportunities of RWD analyses in different healthcare systems. Existing European RWD analysis initiatives will also be included.

The consortium consists of ten European partners. In addition to the German Federal Institute for Drugs and Medical Devices (BfArM), partners include the Fraunhofer Institute for Algorithms and Scientific Computing (SCAI) and the German Center for Neurodegenerative Diseases (DZNE) from Germany, Aarhus University (AU) and the Danish Medicines Agency (DKMA) from Denmark, the University of Eastern Finland (UEF) and the IT Center for Science (CSC) from Finland, the National Authority of Medicines and Health Products, I. P. (INFARMED) from Portugal, the European Organization for Professionals and Patients with ALS (EUpALS), and the European Institute for Women's Health (EIWH).

The European Commission (Horizon Europe program) funds the project from January 2023 to December 2026.

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