In this edition we share some exciting news about the EPTRI Position paper and proposed Amendments to the EU Pharma Legislation Revision. You will also find updates on some interesting upcoming and past events. Enjoy!
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EPTRI PROPOSAL FOR AMENDMENTS TO THE EU PHARMA LEGISLATION REVISION
After a thoughtful analysis and in line with the EPTRI Position paper available here yesterday, 07 November 2023, EPTRI submitted its proposal for amendments to the attention of some interested Members of the European Parliament (MEPs). The amendments are related to...
EPTRI POSITION PAPER ON THE EU PHARMA LEGISLATION REVISION
On October 16th EPTRI, after collecting the opinion of several key Paediatric Research Organisation and paediatric interested Stakeholders, provided its feedback on the EU Pharma Legislation by submitting the Position Paper ‘PROPOSED CHANGES TO THE PAEDIATRIC...
EPTRI participation at the MEP Interest Group 2023 Conference
The MEP Interest Group 2023 Conference “COUNTDOWN TO EU ELECTIONS: How can policymakers secure the promise of Advanced Therapies for patients over the next 6 months?”, organised by the European Alliance for Transformative Therapies (TRANSFORM) was held last October...
Approval of AGAMREE® for the treatment of DMD paediatric patients on the horizon!
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in favor of the approval of AGAMREE® (vamorolone) for the treatment of Duchenne Muscular Dystrophy (DMD) patients aged 4 years and older. Vamorolone is a novel drug candidate...
EPTRI BoD Member Donato Bonifazi at the Enpr-EMA annual workshop
On 10 October 2023, the 2023 annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) presented an opportunity for stakeholders to come together and exchange ideas to improve clinical trials for children. The event...
EPTRI Webinar – Investment and commercial opportunities in child health technology
Our first webinar “Investment and commercial opportunities in child health technology” chaired by Paul Dimitri, was held on September 5th. This webinar, organized by our Paediatric Medical Device Research Platform, is part of a one year online educational programme...
Hospital Exemption in ATMP development
Within the Revision of the EU general pharmaceuticals legislation, we call for the European Commission to maintain a strong focus on the societal aim of health equity and to further support our researchers, clinicians, and hospital pharmacists in their various roles...
Medical Devices for children: EPTRI supports the EAP open letter
EPTRI and other 21 representatives of European medical associations dedicated to child health and medical care have supported the open letter of the European Academy of Paediatrics (EAP) to Commissioner Stella Kyriakides, the European Commissioner for Health and Food...
European Alliance for Transformative Therapies (TRANSFORM) MEP Interest Group discussion
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...