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Infradev - European Paediatric Translational Research Infrastructure

Objetivo

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.

Ámbito científico

Palabras clave

Programa(s)

Tema(s)

Convocatoria de propuestas

H2020-INFRADEV-2016-2017

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Convocatoria de subcontratación

H2020-INFRADEV-2017-1

Régimen de financiación

RIA - Research and Innovation action

Coordinador

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Aportación neta de la UEn
€ 470 650,00
Dirección
VIA NICOLO PUTIGNANI 178
70122 Bari
Italia

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Región
Sud Puglia Bari
Tipo de actividad
Research Organisations
Enlaces
Coste total
€ 795 650,00

Participantes (31)

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Última actualización: 4 Octubre 2023

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Permalink: https://cordis.europa.eu/project/id/777554/es

European Union, 2024