About ERAMET

What is ERAMET?

ERAMET stands for “Ecosystem for Rapid Adoption of Modelling and Simulation Methods to Address Regulatory Needs in the Development of Orphan and Paediatric Medicines.” The project is EU-funded and managed by a multidisciplinary consortium of 17 partners located in Belgium, Norway, the United Kingdom, Italy, Spain, France, Greece and the Netherlands.

Our objective

The primary goal of ERAMET is to create a comprehensive system that aids in the development and regulatory approval of drugs for children and rare diseases. This system will help both drug developers and regulators make better decisions using advanced modelling and simulation (M&S) methods and real-world data, such as medical records and registries.

Our three pillars

• Repository — a central hub that connects important questions, data and methods, making it easier to find and use the right information.
• Standards development — establishing and validating high-quality standards for data and analytical methods, including cutting-edge approaches like digital twins, artificial intelligence (AI) and hybrid methods combining different types of data and analyses.
• AI-based platform — an advanced platform that automates data collection, formatting and analysis using M&S. The platform also assesses the credibility of the data and methods used, ensuring reliability and accuracy.

Our consortium members

ERAMET is a collaborative effort that brings together a diverse group of experts and organisations:

• Regulators: national authorities from Belgium (FAMHP), Spain (AEMPS), the Netherlands (CBG), France (ANSM), and members of the European Medicines Agency (EMA) committees.
• SMEs: specialised companies in drug development and assessment such as Certara, CVBF, Aparito, SRLAB and Aridhia.
• Academia: leading universities and research institutions with expertise in rare and paediatric diseases and M&S, including the University of Valencia (UV), University of Warwick (UoW), University of Namur (UNamur), University of Catania (UNICT), University Medical Center Groningen (UMCG) and University College London (UCL).

Why ERAMET matters

ERAMET aims to simplify and improve the drug development process for children and rare diseases by implementing a question-centric approach. This approach focuses on answering key questions that arise during drug development and regulatory assessment. By using advanced M&S methods and ensuring the credibility of the data, ERAMET will facilitate faster and more reliable drug approvals, ultimately benefiting patients with unmet medical needs.