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Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices

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.

Call for proposal

H2020-NMBP-2016-2017

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Sub call

H2020-NMBP-2017-two-stage

Coordinator

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
Net EU contribution
€ 1 090 625,00
Address
Rue Leblanc 25
75015 Paris 15
France

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00

Participants (16)

STIFTELSEN SINTEF
Norway
Net EU contribution
€ 1 656 917,50
Address
Strindveien 4
7034 Trondheim

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Region
Norge Trøndelag Trøndelag
Activity type
Research Organisations
Other funding
€ 0,00
EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT
Switzerland
Net EU contribution
€ 476 096,25
Address
Ueberlandstrasse 129
8600 Dubendorf

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Region
Schweiz/Suisse/Svizzera Zürich Zürich
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
Net EU contribution
€ 966 425,00
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven

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Region
West-Nederland Utrecht Utrecht
Activity type
Research Organisations
Other funding
€ 0,00
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION
Belgium
Net EU contribution
€ 458 955,00
Address
Rue De La Loi 200
1049 Brussels

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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
Other funding
€ 0,00
GESELLSCHAFT FUR BIOANALYTIK MUNSTER EV
Germany
Net EU contribution
€ 110 562,50
Address
Mendelstrasse 17
48149 Munster

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Region
Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt
Activity type
Research Organisations
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.

WESTFAELISCHE WILHELMS-UNIVERSITAET MUENSTER
Germany
Net EU contribution
€ 264 062,50
Address
Schlossplatz 2
48149 Muenster

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Region
Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
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
€ 36 592,25
Address
Mendelstrasse 11
48149 Munster

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Region
Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt
Activity type
Research Organisations
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
€ 226 937,50
Address
Mendelstrasse (Technologiehof L2) 11
48149 Munster

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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)
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
€ 47 812,50
Address
Mendelstrasse 17
48149 Munster

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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)
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

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Region
Ireland Eastern and Midland Dublin
Activity type
Higher or Secondary Education Establishments
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

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Region
North West (England) Merseyside Liverpool
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITY OF BRIGHTON
United Kingdom
Net EU contribution
€ 214 806,25
Address
Lewes Road Mithras House
BN2 4AT Brighton

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Region
South East (England) Surrey, East and West Sussex Brighton and Hove
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
GREENDECISION SRL
Italy
Net EU contribution
€ 450 266,25
Address
Via Torino 155/a
30172 Venezia

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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)
Other funding
€ 0,00
BIOKERALTY RESEARCH INSTITUTE AIE
Spain
Net EU contribution
€ 102 395,00
Address
Entidad Arcaute 005 Arcaute
01192 Arcaute Alava

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Region
Noreste País Vasco Araba/Álava
Activity type
Other
Other funding
€ 0,00
AMATSIGROUP
France
Net EU contribution
€ 196 306,25
Address
Parc De Genibrat
31470 Fontenilles

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Region
Occitanie Midi-Pyrénées Haute-Garonne
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
EUROPEAN RESEARCH SERVICES GMBH
Germany
Net EU contribution
€ 186 750,00
Address
Huefferstr. 5
48149 Muenster

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Region
Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00