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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.

Field of science

  • /engineering and technology/industrial biotechnology/biomaterials
  • /medical and health sciences/medical biotechnology/nanomedicine

Call for proposal

H2020-NMBP-2017-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

GESELLSCHAFT FUR BIOANALYTIK MUNSTER EV
Address
Mendelstrasse 11
48149 Munster
Germany
Activity type
Research Organisations
EU contribution
€ 804 500

Participants (13)

STIFTELSEN SINTEF

Participation ended

Norway
EU contribution
€ 12 730
Address
Strindveien 4
7034 Trondheim
Activity type
Research Organisations
EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT
Switzerland
EU contribution
€ 476 096,25
Address
Ueberlandstrasse 129
8600 Dubendorf
Activity type
Higher or Secondary Education Establishments
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
EU contribution
€ 928 925
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven
Activity type
Research Organisations
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION
Belgium
EU contribution
€ 458 955
Address
Rue De La Loi 200
1049 Brussels
Activity type
Research Organisations
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
France
EU contribution
€ 972 092,25
Address
Rue Leblanc 25
75015 Paris 15
Activity type
Research Organisations
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Ireland
EU contribution
€ 633 990
Address
College Green
2 Dublin
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 848 441,25
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
UNIVERSITY OF BRIGHTON
United Kingdom
EU contribution
€ 214 806,25
Address
Lewes Road Mithras House
BN2 4AT Brighton
Activity type
Higher or Secondary Education Establishments
GREENDECISION SRL
Italy
EU contribution
€ 450 266,25
Address
Via Torino 155/A
30172 Venezia
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BIOKERALTY RESEARCH INSTITUTE AIE
Spain
EU contribution
€ 102 395
Address
Entidad Arcaute, 005, Arcaute
01192 Arcaute Alava
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
AMATSIGROUP
France
EU contribution
€ 196 306,25
Address
Parc De Genibrat
31470 Fontenilles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUROPEAN RESEARCH SERVICES GMBH
Germany
EU contribution
€ 186 750
Address
Roentgenstrasse 19
48149 Muenster
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SINTEF AS
Norway
EU contribution
€ 1 681 687,50
Address
Strindvegen 4
7034 Trondheim
Activity type
Research Organisations