European Medicines Agency - Regulatory - Regulation of medicines

D - Description

  Description

Name

EPTRI (AISBL) - European Paediatric Translational Research Infrastructure (Association Internationale Sans But Lucrative)
Year of foundation 2018/2024: EPTRI began as a project funded by the H2020-INFRADEV-01-2017 programme in 2018. From March 2024 EPTRI is an autonomous legal entity registered as an Association Internationale Sans But Lucrative (AISBL).
Preterm and/or term newborn Yes
Infants from 1 month to less than 24 months of age Yes
Children from 2 years to less than 12 years of age Yes
Adolescents from 12 years to less than 18 years Yes
Paediatric age ranges of study participants covered by the network All paediatric age ranges (0-18 years).
Multispeciality? Specify All disease areas
Speciality/disease specific? Specify N.A.
Conditions covered? Specify N.A.
Procedure/Intervention specific? Specify N.A.
Number of collaborating countries 26
List of collaborating countries Including Countries outside Europe. Albania, Austria, Belgium, Cyprus, Canada, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Russian Federation, Slovenia, Spain, Switzerland, The Netherlands, United Kingdom, Ukraine.
Number of collaborating centres 114
List of collaborating centres At the following link is available the EPTRI Memorandum of Understanding signed by all collaborating centres: https://drive.google.com/file/d/1kLgdkgfo0uTXE0HSq54KOLxA5lWOhKqu/view?usp=sharing
Type of activity/studies
Clinical Studies Yes
Experimental research Yes
Other activity Providing access to paediatric patients’ cohorts. Providing access to paediatric samples and related data. Advice on in-vivo / in-silico nonclinical study design. Advice on in-vivo/in-silico clinical study design. Advice and Document preparation for regulatory and ethic procedures. Advice on preparing HTA reports for paediatric medicines, diagnostic and MDs. Advice on Data and sample sharing preparation. Supporting application to (public and private) funding opportunities.