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EU-Förderung (7.967.941 €): Regulatory Science Framework for Nano(bio)materialbasierte Medizinprodukte und -geräte Hor01.12.2017 EU-Rahmenprogramm für Forschung und Innovation "Horizont"
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Regulatory Science Framework for Nano(bio)materialbasierte Medizinprodukte und -geräte
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.
Geförderte Unternehmen:
| Firmenname | Förderungssumme |
| 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 € |
Quelle: https://cordis.europa.eu/project/id/761104
Diese Bekanntmachung wurde von Englisch nach Deutsch übersetzt. Die Bekanntmachung bezieht sich auf einen vergangenen Zeitpunkt, und spiegelt nicht notwendigerweise den heutigen Stand wider.
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