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Financement de l’UE (7 967 941 €) : Cadre scientifique réglementaire pour les produits et dispositifs médicaux à base de nano(bio)matériaux Hor01/12/2017 Programme de recherche et d'innovation de l'UE « Horizon »
Vue d’ensemble
Texte
Cadre scientifique réglementaire pour les produits et dispositifs médicaux à base de nano(bio)matériaux
REFINE proposes a Regulatory Science Framework for the risk-benefit assessment of medical products and medical devices that are based on nanomedicines and biomaterials. The heart of our framework is the development of a product-specific Decision Support System that identifies the most efficient way to deliver the data required by regulation by the best-fitting methods. The decision tree will explicate the product’s specific regulatory challenges and the priorities of both missing data and missing methods to match these challenges. It will thus allow planning a cost-and time efficient strategy both for necessary measurements and for the advancement of methods. Our approach is aligned with the industrial R&D practice of stage gating. We will demonstrate the relevance of the framework for the most pressing regulatory challenges, which are: borderline products, nanosimilars, and products combining several functionalities. In order to do so, we will identify the regulatory challenges with Regulation Authorities from Europe and abroad, and design methods for tiered decision tree, guided by the latest scientific knowledge. We will study/predict physiological distribution of nanomedicines and biomaterials, as well as develop and validate new analytical or experimental methods and assays requested by the regulators. These latter development will be performed in a quality management system, ensuring the possible standardisation of our assays. REFINE will gather a wide community of stakeholders in regulation, industry, science, technology development, patients, and end-users, into a Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicine.
| Amatsigroup | 196 306 € |
| Biokeralty Research Institute AIE | 102 395 € |
| Commissariat a L Energie Atomique et aux Energies Alternatives | 957 092 € |
| Eidgenossische Materialprufungs- UND Forschungsanstalt | 476 096 € |
| European Research Services GmbH | 186 750 € |
| Gesellschaft FUR Bioanalytik Munster e. V. | 819 500 € |
| Greendecision Srl | 450 266 € |
| IBE R&D Institute FOR Lung Health gGmbH | 0,00 € |
| JRC -Joint Research Centre- European Commission | 458 955 € |
| Oxprotect GmbH | 0,00 € |
| Rijksinstituut Voor Volksgezondheid EN Milieu | 928 925 € |
| Sintef AS | 1 681 688 € |
| Stiftelsen Sintef | 12 730,00 € |
| Tascon Gesellschaft FUR Oberflachen-UND Materialcharakterisierung mbH | 0,00 € |
| The Provost, Fellows Foundation Scholars & the Other Members of Board, of the College of the Holy & Undivided Trinity of Queen Elizabeth Near Dublin | 633 990 € |
| The University of Liverpool | 848 441 € |
| Universitaet Muenster | 0,00 € |
| University of Brighton | 214 806 € |
https://cordis.europa.eu/project/id/761104
Cette annonce se réfère à une date antérieure et ne reflète pas nécessairement l’état actuel.