The following table provides information about the project.
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
|Coordinator Country||France [FR]|
|Total cost||7˙967˙941 €|
|EC max contribution||7˙967˙941 € (100%)|
1. H2020-EU.188.8.131.52. (Ensuring the safe and sustainable development and application of nanotechnologies)
|Duration (year-month-day)||from 2017-12-01 to 2021-11-30|
Take a look of project's partnership.
|1||COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES||FR (PARIS 15)||coordinator||1˙090˙625.00|
|2||STIFTELSEN SINTEF||NO (TRONDHEIM)||participant||1˙656˙917.00|
|3||RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU||NL (BILTHOVEN)||participant||966˙425.00|
|4||THE UNIVERSITY OF LIVERPOOL||UK (LIVERPOOL)||participant||848˙441.00|
|5||GESELLSCHAFT FUR BIOANALYTIK MUNSTER EV||DE (MUNSTER)||participant||685˙967.00|
|6||THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN||IE (DUBLIN)||participant||633˙990.00|
|7||EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT||CH (DUBENDORF)||participant||476˙096.00|
|8||JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION||BE (BRUSSELS)||participant||458˙955.00|
|9||GREENDECISION SRL||IT (Venezia)||participant||450˙266.00|
|10||UNIVERSITY OF BRIGHTON||UK (BRIGHTON)||participant||214˙806.00|
|12||EUROPEAN RESEARCH SERVICES GMBH||DE (MUENSTER)||participant||186˙750.00|
|13||BIOPRAXIS RESEARCH AIE||ES (MINANO ALAVA)||participant||102˙395.00|
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.
Work performed, outcomes and results: advancements report(s)
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The information about "REFINE" are provided by the European Opendata Portal: CORDIS opendata.
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