Objective 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. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health sciencesmedical biotechnologynanomedicinemedical and health sciencesbasic medicinepharmacology and pharmacypharmacokineticsengineering and technologynanotechnologynano-materialsengineering and technologyindustrial biotechnologybiomaterials Programme(s) H2020-EU.2.1.2. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies Main Programme H2020-EU.2.1.2.2. - Ensuring the safe and sustainable development and application of nanotechnologies Topic(s) NMBP-14-2017 - Regulatory Science Framework for assessment of risk benefit ratio of Nanomedicines and Biomaterials Call for proposal H2020-NMBP-2016-2017 See other projects for this call Sub call H2020-NMBP-2017-two-stage Funding Scheme RIA - Research and Innovation action Coordinator GESELLSCHAFT FUR BIOANALYTIK MUNSTER EV Net EU contribution € 250 437,50 Address Mendelstrasse 17 48149 Munster Germany See on map Region Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (17) Sort alphabetically Sort by Net EU contribution Expand all Collapse all Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. WESTFAELISCHE WILHELMS-UNIVERSITAET MUENSTER Germany Net EU contribution € 264 687,50 Address Schlossplatz 2 48149 Muenster See on map Region Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. IBE R&D INSTITUTE FOR LUNG HEALTH GGMBH Germany Net EU contribution € 61 875,00 Address Mendelstrasse 11 48149 Munster See on map Region Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. OXPROTECT GMBH Germany Net EU contribution € 162 500,00 Address Mendelstrasse (technologiehof l2) 11 48149 Munster See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. TASCON GESELLSCHAFT FUR OBERFLACHEN- UND MATERIALCHARAKTERISIERUNG MBH Germany Net EU contribution € 80 000,00 Address Mendelstrasse 17 48149 Munster See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 STIFTELSEN SINTEF Participation ended Norway Net EU contribution € 12 730,00 Address Strindveien 4 7034 Trondheim See on map Region Norge Trøndelag Trøndelag Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT Switzerland Net EU contribution € 476 096,25 Address Ueberlandstrasse 129 8600 Dubendorf See on map Region Schweiz/Suisse/Svizzera Zürich Zürich Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU Netherlands Net EU contribution € 928 925,00 Address Antonie van leeuwenhoeklaan 9 3721 MA Bilthoven See on map Region West-Nederland Utrecht Utrecht Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION Belgium Net EU contribution € 458 955,00 Address Rue de la loi 200 1049 Bruxelles / brussel See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES France Net EU contribution € 957 092,25 Address Rue leblanc 25 75015 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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 Ireland Net EU contribution € 633 990,00 Address College green trinity college D02 CX56 Dublin 2 See on map Region Ireland Eastern and Midland Dublin Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 THE UNIVERSITY OF LIVERPOOL United Kingdom Net EU contribution € 848 441,25 Address Brownlow hill 765 foundation building L69 7ZX Liverpool See on map Region North West (England) Merseyside Liverpool Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITY OF BRIGHTON United Kingdom Net EU contribution € 214 806,25 Address Lewes road mithras house BN2 4AT Brighton See on map Region South East (England) Surrey, East and West Sussex Brighton and Hove Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 GREENDECISION SRL Italy Net EU contribution € 450 266,25 Address Via torino 155/a 30172 Venezia See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Nord-Est Veneto Venezia Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 BIOKERALTY RESEARCH INSTITUTE AIE Spain Net EU contribution € 102 395,00 Address Entidad arcaute 005 arcaute 01192 Arcaute alava See on map Region Noreste País Vasco Araba/Álava Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 AMATSIGROUP France Net EU contribution € 196 306,25 Address Parc de genibrat 31470 Fontenilles See on map Region Occitanie Midi-Pyrénées Haute-Garonne Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 EUROPEAN RESEARCH SERVICES GMBH Germany Net EU contribution € 186 750,00 Address Huefferstr. 5 48149 Muenster See on map Region Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 SINTEF AS Norway Net EU contribution € 1 681 687,50 Address Strindvegen 4 7034 Trondheim See on map Region Norge Trøndelag Trøndelag Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00
