EU-funded · Horizon Europe · Grant 101137141

Advancing paediatric and orphan drug development through modelling and simulation

ERAMET builds a transparent European ecosystem where developers and regulators use modelling & simulation, artificial intelligence and real-world data to make better decisions about medicines for children and people with rare diseases.

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What is ERAMET?

An acronym with a long name and a simple aim

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 supports the development of orphan and paediatric medicines through an integrated approach that helps developers and regulators make informed drug development and assessment decisions. It promotes innovative methods such as modelling and simulation, AI and real-world data to advance regulatory science across Europe.

Read more about the project

Our objective

To create a comprehensive system that aids the development and regulatory approval of drugs for children and rare diseases, helping both developers and regulators make better decisions using advanced modelling and simulation and real-world data such as medical records and registries.

  • Question-centric approach to drug development
  • Credibility assessment of data and methods
  • Faster, more reliable regulatory decisions

The three pillars

How the ecosystem is built

01

Repository

A central hub that connects important questions, data and methods, making it easier to find and use the right information.

02

Standards development

Establishing and validating high-quality standards for data and analytical methods, including digital twins, AI and hybrid approaches that combine different types of data and analyses.

03

AI-based platform

An advanced platform that automates data collection, formatting and analysis using M&S, and assesses the credibility of the data and methods used to ensure reliability and accuracy.

A consortium of 17 partners across Europe

University of NamurSystems Resource Lab (SRL)Federal Agency for Medicines and Health ProductsUniversity of ValenciaConsorzio per Valutazioni Biologiche e FarmacologicheFondazione per la ricerca Farmacologica Gianni Benzi OnlusUniversity Medical Center GroningenUniversity of CataniaNational Agency for the Safety of Medicines and Health ProductsAgentschap College Ter Beoordeling Van GeneesmiddelenEuropean Business Summit NetworkSpanish Agency of Medicines and Pharmaceutical ProductsCertara UK LimitedThe University of WarwickUniversity College LondonAridhia Informatics LimitedAthena Research CenterUniversity of NamurSystems Resource Lab (SRL)Federal Agency for Medicines and Health ProductsUniversity of ValenciaConsorzio per Valutazioni Biologiche e FarmacologicheFondazione per la ricerca Farmacologica Gianni Benzi OnlusUniversity Medical Center GroningenUniversity of CataniaNational Agency for the Safety of Medicines and Health ProductsAgentschap College Ter Beoordeling Van GeneesmiddelenEuropean Business Summit NetworkSpanish Agency of Medicines and Pharmaceutical ProductsCertara UK LimitedThe University of WarwickUniversity College LondonAridhia Informatics LimitedAthena Research Center
Researchers working together at a computer
Pharmacokinetic and pharmacodynamic models, agent-based models and machine learning all play a role.

Explainer

What are modelling and simulation methods?

Modelling and simulation (M&S) methods use computational and mathematical techniques to replicate biological systems, disease progression and drug interactions, helping predict outcomes, optimise treatments and reduce reliance on clinical trials.

Pharmacokinetic and pharmacodynamic models simulate drug absorption and effects, agent-based models study disease spread and patient behaviour, and machine-learning techniques predict treatment responses for personalised medicine.

Stakeholder network

Become part of a European community shaping the future of medicine development.

Join the network