Objective
The general objective of this project is to design the framework for the European Paediatric Translational Research Infrastructure (EPTRI), a new Research Infrastructure (RI) aimed to enhance technology-driven paediatric research in discovery and early development phases to be translated into clinical research and paediatric use of medicines.
The starting point of the proposal is the serious lack of medicines for children in EU and worldwide as well as the lack of a developmental model for paediatric medicines that integrates technology-driven aspects with the methodological, ethical and regulatory framework. The design for this new RI will be based on the following main pillars:
• to harness efficiency and delivery of paediatric research activities and services strengthening collaboration within the scientific paediatric community;
• to be a complementary RI in the context of the existing RIs covering the current gaps, while avoiding any duplication;
• to develop a one-stop-shop for advice in paediatric drug development.
To prepare a valuable Conceptual Design Report (CDR), the project encompasses three phases. During the Context Analysis phase, that will be performed in 5 technical and scientific domains (1- Paediatric Medicines Discovery, 2- Paediatric Biomarkers and Biosamples, 3-Developmental Pharmacology, 4-Paediatric Medicines Formulations and Medical Devices, 5- Underpinning Medicines Development to Paediatric Clinical Studies) the perceived value and the possible gaps to be covered will be estimated by enquiring the scientific communities and many other Stakeholders.
During the Operational phase, the different components of the new RI will be depicted including governance model strategies for interaction with national Authorities and the existing RIs, the IT-architecture model, services to be provided and a business plan.
Finally, a Feasibility phase is proposed to develop virtual exercises simulating the operations of the RI.
The final result of the project will be the CDR to realize EPTRI.
Fields of science
Programme(s)
Topic(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
70122 Bari
Italy
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Participants (31)
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
231261 Pavia
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
70010 Valenzano Bari
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35127 Padova
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1081 HZ Amsterdam
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WC1E 6BT London
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151 25 Maroussi
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8010 Graz
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
20126 Milano
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2371 Agios Dometios
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75012 Paris
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6525 XZ Nijmegen
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L69 7ZX Liverpool
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021945 Bucuresti
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04730 Warszawa
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00165 Roma
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142 20 Praha 4
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08950 Esplugues De Llobregat
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603950 Nizhny Novgorod
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28020 Madrid
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75014 Paris
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1001 Tirana
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32000 Haifa
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51005 Tartu
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91054 Erlangen
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3008 Bern
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462 80 Vanersborg
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3584 CX Utrecht
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04050 Kiev
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
2000 Antwerpen
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1135 Budapest
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2650 Edegem
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