ERAMET project launched: improving the drug regulation system

On March 4 and 5, the ERAMET project kick-off was held at UNamur. This kick-off event brought together some forty participants at UNamur's Research Administration.

ERAMET is a project funded to the tune of 6 million euros as part of the Horizon Europe program. It is a collaborative, multidisciplinary project that aims to improve the scientific database that guides regulatory bodies' decisions on medicines, particularly for rare and pediatric conditions. The project is coordinated by Flora Musuamba Tshinanu, Professor in the Department of Pharmacy at UNamur. This ambitious project involves no fewer than 17 partners, including seven universities with UNamur as coordinator, four national drug regulatory agencies and private companies.

At the launch event, the first day was open to all, with an introduction to the project at the opening of the day by Flora Musuamba Tshinanu. Perspectives from the regulatory point of view on the challenges linked to the evaluation of pediatric drugs and rare diseases, and those in the industry and data fields, were addressed. The second day was reserved for the consortium.

Over a four-year period, researchers from Belgium, Spain, Italy, Germany, the UK, the Netherlands and Norway will combine their expertise in the fields of numerics, mathematical modeling and pharmacology. Their aim is to combine data from online sources, such as electronic health records, with data from modeling and simulation, to provide regulators with up-to-date information to enable them to make informed decisions. To this end, the project will analyze five cases of specific drug use for pediatric and rare conditions, with the aim of assessing the associated benefits and risks. Each of these cases should lead to the approval of at least one modeling and simulation tool by the European Medicines Agency (EMA).

The deliverables expected for a project of this scale are numerous. In particular, they include the creation of a repository, the establishment of quality standards, the implementation of training courses for healthcare players, and the development of an artificial intelligence platform dedicated to automating data collection, formatting, analysis and evaluation.

ERAMET is a project of the European Union's HORIZON Europe programming.

Grantor: 101137141 - ERAMET