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”,...
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Interview with the expert – ATMPs as Therapy Options in Europe
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....
ENVI POSITION FOR THE NEW PHARMACEUTICAL LEGISLATION: WHAT’S NEW FOR PAEDIATRICS?
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...
Establishment of EPTRI AISBL as a legal entity
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...
OrphaDev4Kids project approved
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...
Interview with the expert – Informed Consent for Paediatric Clinical Studies
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. ...
Fourth webinar on Patient and Public Involvement and Engagement in Child Health Tech Development
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 Hospital Exemption
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...
EPTRI PROPOSAL FOR AMENDMENTS TO THE EU PHARMA LEGISLATION REVISION – current update
Following on from EPTRI's proposals for amendments to the Pharmaceutical Package legislation, which were shared with some Members of the European Parliament (MEPs), we are pleased to report that most of the points raised by EPTRI have been endorsed and submitted by...
Third webinar on Robotics for child health
The 3rd webinar on Robotics for child health organised by the EPTRI Medical Devices Platform was held online on 9th of January 2024. It was a great occasion to immerse into the advances in social and assistive robotics solutions, motor and behavioral rehabilitation,...