Our president, Karel Allegaert, participated in the paediatric committee (PDCO) scientific meeting related to the Belgian presidency that was held last week in Leuven. Related to the ongoing revision of the EMA guideline on neonatal clinical studies, Karel discussed...
The 5th webinar on Co-design in Child Health Technology organized by the EPTRI Medical Devices Platform was held online on 7th May of 2024. Participants had the chance to learn more about the impact of partnerships and co-design in shaping child health technology...
Donato Bonifazi and Adriana Ceci, both members of our Board of Directors, have co-authored the research paper entitled: “Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective”,...
Based on the current political developments in Europe and the formulation of a National Strategy for Rare Diseases there is a need to provide suitable therapeutic options to underserved populations such as paediatric population and people living with rare diseases....
On 19 March, the Committee on the Environment, Public Health and Food Safety (ENVI), as the committee responsible for the procedure, adopted its position on the new Directive and Regulation on medicinal products for human use. MEPs agreed on a number of...
We are very happy to announce that incorporated in the form of an Association International Sans But Lucrative (AISBL). The approval was granted by the Belgium Government as EPTRI is based in Leuven. This means that EPTRI can now apply to grants and other funding as...
We are excited to announce that the proposal OrphaDev4Kids has been approved. This collaborative project aims to address the issue of Orphan medical devices (MDs) to be used in the paediatric population. Paediatric MDs development is more complex and riskier for...
Today we have with us Viviana Giannuzzi, coordinator of the research department at Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, ethical and regulatory expert in EU and national research projects, member of the Paediatric Committee (PDCO) at the EMA. ...
The 4th webinar on Patient and Public Involvement and Engagement in Child Health Tech development organized by the EPTRI Medical Devices Platform was held online on 5th March of January 2024. Participants had the chance to learn more about on the impact of involving...
EPTRI supports the joint statement on Hospital Exemption. The signatories of this statement are key stakeholders in the healthcare ecosystem at both the European Union and Member State level comprising of health care professionals’ associations, patient organisations...