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ID-EPTRI

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Infradev European Paediatric Translational Research Infrastructure

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... ver más

30/04/2020

CONSORZIO PER VALU...

3M€

Presupuesto del proyecto: 3M€

Líder del proyecto

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMAC... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 32 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2020-04-30

INFRADEV-01-2017: Design Studies Specific Challenge:New leading-edge research infrastructures in all fields of science and technology...

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

32 Participantes

CONSORZIO PER VALUTAZIONI BI...

795.65K€ | Lider

FANOX ELECTRONIC

323.70K€ | Participante

TECHNION ISRAEL INSTITUTE O...

76.25K€ | Participante

UNIVERSITY COLLEGE LONDON

173.75K€ | Participante

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Duración del proyecto: 27 meses Fecha Inicio: 2018-01-25
Fecha Fin: 2020-04-30

Líder del proyecto

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMAC... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 3M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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.

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