ERAMET

The project aims to create a transparent ecosystem to foster decision-making in paediatric and orphan drugs development by integrating innovative methodologies, such as modelling and simulation (M&S) methods and related data types, within regulatory procedures. With three pillars: a data repository, the development of high-quality standards for data and analytical methods, and an Artificial Intelligence-based platform, it aims to establish the credibility of M&S methods and related results as sources of evidence within regulatory procedures.

ROLE OF THE FOUNDATION
The Foundation is involved in constructing the integrated model for the application of innovative methodologies in paediatric and orphan drug development, while also assessing their regulatory acceptability. Furthermore, it is involved in applying the model to three specific case studies of paediatric and rare diseases.Lastly, the Foundation collaborates to the preparation and application of the qualification procedure to the European Medicines Agency (EMA) to validate the project methodology tools.

FUNDED BY: Horizon Europe–Health, GA 101137141 2024-27 (www.cordis.europa.eu/project/id/101137141).