European Paediatric Transnational Research Infrastructure

EPTRI stands for European Paediatric Transnational Research Infrastructure, an is an initiative involving numerous research units gathered together to advance paediatric research and accelerate the development of medicines, technologies advanced therapies and devices for children. EPTRI began as a project funded by the H2020 funding programme in 2018 and arised from the need to address the global shortage of paediatric medications.

EPTRI has officially achieved the status of a legal entity in March 2024, registered as an international non-profit association under Belgian law and based at Leuven University and already includes 26 Members from 14 countries and it is rapidly evolving. Members include universities, hospitals, research organisations, and health institutions.

EPTRI aims to create an open science platform where researchers can collaborate across geographical, institutional, and financial boundaries.

Vision: To enhance knowledge of children's growth and ontogenetic characteristics, supporting the identification of new therapies and services for their development.

Mission: To implement specialized skills, research strategies, access to key technologies, standardized models, and analytical tools to advance paediatric research.

EPTRI is organised as a distributed research infrastructure according to the Hub and Spoke Model. that consists of a Single Access Point (SAP) which is directly linked to the Central Management Office (CMO), which interconnects all the research units (RUs) clustered as Thematic Research Platforms (TRPs - according to their area of expertise) or National Nodes (NNs - according to their location).  

EPTRI offers services in five technical and scientific areas  identified during its project phase to meet diverse paediatric research needs.

Paediatric Disease Characterisation​:Disease characterisation combines pediatricprofiling, translational research, and  biomarker discovery using biophysics,omics, and  computational tools to speed therapydevelopment.​

Paediatric MedicinesDevelopment : Medicines Development supports drug development with non-clinical expertise, including in vitro systems, juvenile models, in silico  predictions, paediatric formulations, advanced therapies and EMA procedures.​

Paediatric ​Medical Devices Development: Medical DeviceDevelopment facilitatesdesign, prototyping,safety and usabilitytesting of paediatricmedical devices, guidingtowards theircommercialisation.​

Paediatric Clinical Research​: Clinical Research Services combine methodological, regulatory, and operational expertise for pediatric studies, integrating advanced therapy technologies like gene, cell, and personalised treatments.​

Paediatric Health Data : Health Data provides secure, GDPR-compliant access to real-world paediatric data, supporting FAIR sharing,anonymisation, e Source integration, secondary use,and child-specific privacy safeguards.​

EPTRI contributes significantly to the European research landscape through several important partnerships: 

1. ENPR-EMA (European Network of Paediatric Research at the European Medicines Agency): EPTRI is a member under Category 3, focusing on networks that specialize in clinical trial methodology and paediatric drug development, thus supporting high-quality trials. 

2. European Open Science Cloud (EOSC): EPTRI is a member of EOSC, enhancing collaboration, improving data sharing, and utilizing open science resources to advance paediatric research and digital innovation. 

3. EU Health Coalition: As a partner, EPTRI contributes to actions that integrate paediatric research into health policies and initiatives. 

4. European Alliance for Transformative Therapies (TRANSFORM): EPTRI is an active member, supporting lobbying efforts to improve the regulatory environment for paediatric research.