Real4Reg

The Real4Reg project stands for development, optimisation and implementation of artificial intelligence methods for RWD analyses in regulatory decision-making and health technology assessment along the product lifecycle. Real4Reg addresses the challenges and opportunities of RWD analyses across different health care systems by involving multiple stakeholders to work together in a collaborative approach, also outreaching to already established European initiatives. The consortium consists of ten European partners and is coordinated by the German Federal Institute for Drugs and Medical Devices (BfArM). Other partners are the Fraunhofer Institute for Algorithms and Scientific Computing (SCAI) and the German Center for Neurodegenerative Diseases (DZNE) from Germany, the 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 of Women’s Health (EIWH). Funded by the European Union (Grant agreement ID: 101095353). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the granting authority can be held responsible for them. Newsletter: https://www.real4reg.eu/news-events/newsletter/