| lühikokkuvõte: |
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.
|
