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Infradev - European Paediatric Translational Research Infrastructure

Infradev - European Paediatric Translational Research Infrastructure

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 development model for paediatric medicines that integrates technology-driven aspects with clinical trials. 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 contribute to a one-stop-shop for advice in paediatric drug development;
- to develop a paediatric research infrastructure facility collaborating with already established Research Infrastructures and Common Services.
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 and Preclinical Studies, 2-Biomarkers, 3-Paediatric Pharmacology, 4-Formulation Science, 5-Underpinning Paediatric Studies) the perceived value and the possible gaps to be covered will be estimated by enquiring the scientific Communities, the concerned national Authorities and many other Stakeholders.
During the Operational phase, the different components of the new RI will be organised 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.
In the second year, 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.

Coordinator

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

Address

Via Nicolo Putignani 178
70122 Bari

Italy

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 669 400

Participants (25)

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FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS

Italy

EU Contribution

€ 175 625

EATRIS ERIC

Netherlands

EU Contribution

€ 193 750

UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 173 750

ATHINA-EREVNITIKO KENTRO KAINOTOMIAS STIS TECHNOLOGIES TIS PLIROFORIAS, TON EPIKOINONION KAI TIS GNOSIS

Greece

EU Contribution

€ 141 875

BIOBANKS AND BIOMOLECULAR RESOURCESRESEARCH INFRASTRUCTURE CONSORTIUM(BBMRI-ERIC)

Austria

EU Contribution

€ 135 000

THE CYPRUS FOUNDATION FOR MUSCULAR DYSTROPHY RESEARCH

Cyprus

EU Contribution

€ 123 100

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 147 500

STICHTING KATHOLIEKE UNIVERSITEIT

Netherlands

EU Contribution

€ 122 500

THE UNIVERSITY OF LIVERPOOL

United Kingdom

EU Contribution

€ 108 750

FUNDATIA ROMANIAN ANGEL APPEAL

Romania

EU Contribution

€ 35 000

INSTYTUT POMNIK CENTRUM ZDROWIA DZIECKA

Poland

EU Contribution

€ 97 500

OSPEDALE PEDIATRICO BAMBINO GESU

Italy

EU Contribution

€ 103 750

FYZIOLOGICKY USTAV AKADEMIE VED CESKE REPUBLIKY VEREJNA VYZKUMNA INSTITUCE (VVI)

Czechia

EU Contribution

€ 72 875

FUNDACIO SANT JOAN DE DEU

Spain

EU Contribution

€ 178 125

NIZHEGORODSKIY GOSUDARSTVENNIY UNIVERSITET IM N.I. LOBACHEVSKOGO

Russia

SERVICIO MADRILENO DE SALUD

Spain

EU Contribution

€ 65 250

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 86 250

QENDRES SPITALORE UNIVERSITARE NENETEREZA TIRANE

Albania

EU Contribution

€ 32 375

TECHNION - ISRAEL INSTITUTE OF TECHNOLOGY

Israel

EU Contribution

€ 67 500

TARTU ULIKOOL

Estonia

EU Contribution

€ 28 125

UNIVERSITATSKLINIKUM ERLANGEN

Germany

EU Contribution

€ 103 750

SWISS CLINICAL TRIAL ORGANISATION

Switzerland

EU Contribution

€ 28 750

VASTRA GOTALANDS LANS LANDSTING

Sweden

EU Contribution

€ 35 000

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Netherlands

EU Contribution

€ 53 125

STATE INSTITUTION INSTITUTE OF PEDIATRICS OBSTETRICS AND GYNECOLOGY NATIONAL ACADEMY OF MEDICAL SCIENCES OF UKRAINE

Ukraine

EU Contribution

€ 21 375

Project information

Grant agreement ID: 777554

Status

Ongoing project

  • Start date

    1 January 2018

  • End date

    31 December 2019

Funded under:

H2020-EU.1.4.1.1.

  • Overall budget:

    € 3 071 250

  • EU contribution

    € 3 000 000

Coordinated by:

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

Italy