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...
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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,...
EPTRI feedback to the Methodology Working Party (MWP) 3-years workplan
Last November 2023, a public consultation on the draft revised consolidated 3-year work plan for the Methodology Working Party (MWP) was launched by the European Medicines Agency (EMA) to ask for feedback and gather comments from all key stakeholders. The MWP was...
2nd EPTRI webinar on Immersive reality in child health – another success story
The 2nd webinar on Immersive reality in child health, organised within the one-year educational program set by the EPTRI Paediatric Medical Devices Platform, was held on 14 November 2023. More than 40 attendees had the opportunity to delve into the latest developments...
Newsletter November 2023
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!
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...