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The webinar: “The EU Pharmaceutical Package: A once-in-a-generation opportunity to deliver the promise of transformative therapies to all European patients”, hosted by the MEP Interest Group on Transformative Therapies, will be held online on Thursday, 1 June...
EPTRI is happy to introduce its Research topic on Frontiers in Paediatrics that is cross listed in other three Frontiers Journals. This research topic aims at promoting research on paediatric drug development by facilitating the publication of high-quality studies...
EPTRI is honored to announce its Giovanni Migliaccio’s nomination to represent the research stakeholder group within the TRANSFORM Steering Group. EPTRI will contribute with its pivotal knowledge by representing the academic research perspective. EPTRI will support...
Donato Bonifazi and Lucia Ruggieri, on behalf of EPTRI attended the 11th ACCELERATE Paediatric Oncology Annual Conference held on 9-10 February 2023 in Brussels. The Conference touched on different themes of interest for anti-cancer drug development in oncology. Two...
We are happy to introduce our Research topic on Frontiers in Paediatrics "Supporting the Pediatric Drug Development: From Basic Research to Clinical Studies and Technological Advancements". It is cross listed in other three Frontiers Journals and it is available...
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) report for 2022 is now available. The ENCePP® is a network coordinated by the European Medicines Agency (EMA). The members of this network (the partners) are public institutions...
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a new indication for Fintepla (fenfluramine). Fintepla was indicated for the treatment of seizures associated with Dravet syndrome and now it will also be...
The European Medicines Agency has published for public consultation a reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances. This document describes the current scientific thinking applied to...
The European Medicines Agency (EMA’s) safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. The recommendation follows a review which found that measures to restrict the use of these...
The European Medicines Agency has published for public consultation a concept paper on platform trials. Platform trials have become more common in recent years. Currently, they are frequently seen in Scientific Advice and more rarely as part of Marketing...