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REFINE SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 REFINE project word cloud

Explore the words cloud of the REFINE project. It provides you a very rough idea of what is the project "REFINE" about.

regulatory    nanomedicines    framework    efficient    medical    missing    decision    science    biomaterials    assays    regulation    data    tree    refine   

Project "REFINE" data sheet

The following table provides information about the project.

Coordinator
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES 

Organization address
address: RUE LEBLANC 25
city: PARIS 15
postcode: 75015
website: www.cea.fr

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country France [FR]
 Total cost 7˙967˙941 €
 EC max contribution 7˙967˙941 € (100%)
 Programme 1. H2020-EU.2.1.2.2. (Ensuring the safe and sustainable development and application of nanotechnologies)
 Code Call H2020-NMBP-2017-two-stage
 Funding Scheme /RIA
 Starting year 2017
 Duration (year-month-day) from 2017-12-01   to  2021-11-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
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
11    AMATSIGROUP FR (FONTENILLES) participant 196˙306.00
12    EUROPEAN RESEARCH SERVICES GMBH DE (MUENSTER) participant 186˙750.00
13    BIOPRAXIS RESEARCH AIE ES (MINANO ALAVA) participant 102˙395.00

Mappa

 Project 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.

 Work performed, outcomes and results:  advancements report(s) 

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