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REFINE SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

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.

data regulation nanosimilars heart aligned abroad refine nanomedicine strategy performed pressing industry proposes industrial assays requested priorities tree identifies patients community match nanomedicines stage combining validate analytical borderline functionalities quality framework relevance efficient planning regulatory tiered fitting predict decision standardisation medical missing benefit gather stakeholders latter biomaterials gating explicate guided time risk latest regulators science physiological scientific experimental

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]
Project website	http://refine-nanomed.com
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 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.	FR (PARIS 15)	coordinator	1˙090˙625.00
2	SINTEF AS SINTEF AS Organization address address: STRINDVEGEN 4 city: TRONDHEIM postcode: 7034 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NO (TRONDHEIM)	participant	1˙644˙187.00
3	RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU Organization address address: Antonie Van Leeuwenhoeklaan 9 city: BILTHOVEN postcode: 3721 MA website: www.rivm.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (BILTHOVEN)	participant	966˙425.00
4	THE UNIVERSITY OF LIVERPOOL THE UNIVERSITY OF LIVERPOOL Organization address address: BROWNLOW HILL 765 FOUNDATION BUILDING city: LIVERPOOL postcode: L69 7ZX website: www.liverpool.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LIVERPOOL)	participant	848˙441.00
5	GESELLSCHAFT FUR BIOANALYTIK MUNSTER EV GESELLSCHAFT FUR BIOANALYTIK MUNSTER EV Organization address address: Mendelstrasse 11 city: MUNSTER postcode: 48149 website: www.bioanalytik-muenster.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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 THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN Organization address address: College Green city: DUBLIN postcode: 2 website: www.tcd.ie contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IE (DUBLIN)	participant	633˙990.00
7	EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT Organization address address: UEBERLANDSTRASSE 129 city: DUBENDORF postcode: 8600 website: www.empa.ch contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (DUBENDORF)	participant	476˙096.00
8	JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION Organization address address: Rue de la Loi 200 city: BRUSSELS postcode: 1049 website: http://www.jrc.ec.europa.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUSSELS)	participant	458˙955.00
9	GREENDECISION SRL GREENDECISION SRL Organization address address: VIA TORINO 155/A city: VENEZIA postcode: 30172 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (VENEZIA)	participant	450˙266.00
10	UNIVERSITY OF BRIGHTON UNIVERSITY OF BRIGHTON Organization address address: LEWES ROAD MITHRAS HOUSE city: BRIGHTON postcode: BN2 4AT website: www.brighton.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BRIGHTON)	participant	214˙806.00
11	AMATSIGROUP AMATSIGROUP Organization address address: PARC DE GENIBRAT city: FONTENILLES postcode: 31470 website: www.amatsi.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (FONTENILLES)	participant	196˙306.00
12	EUROPEAN RESEARCH SERVICES GMBH EUROPEAN RESEARCH SERVICES GMBH Organization address address: ROENTGENSTRASSE 19 city: MUENSTER postcode: 48149 website: www.european-research-services.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (MUENSTER)	participant	186˙750.00
13	BIOKERALTY RESEARCH INSTITUTE AIE BIOKERALTY RESEARCH INSTITUTE AIE Organization address address: ENTIDAD ARCAUTE, 005, ARCAUTE city: ARCAUTE ALAVA postcode: 1192 website: www.grupo-praxis.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (ARCAUTE ALAVA)	participant	102˙395.00
14	STIFTELSEN SINTEF STIFTELSEN SINTEF Organization address address: STRINDVEIEN 4 city: TRONDHEIM postcode: 7034 website: www.sintef.no contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NO (TRONDHEIM)	participant	12˙730.00

Map

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.

Deliverables

List of deliverables.
Report on in vitro characterization of nanoparticle distribution	Documents, reports	2019-10-14 11:58:16
Two workshops with strong participation from regulators	Documents, reports	2019-10-14 11:58:14
First draft of whitepaper	Documents, reports	2019-09-05 12:46:09
Reflection Document	Documents, reports	2019-09-05 12:46:09

Take a look to the deliverables list in detail: detailed list of REFINE deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2019	Christina Giannakou, Kukka Aimonen, Louis van Bloois, Julia CatalÃ¡n, Robert E Geertsma, Eric R Gremmer, Wim H de Jong, Peter HJ Keizers, Paul LWJ Schwillens, Rob J Vandebriel, Margriet VDZ Park Sensitive method for endotoxin determination in nanomedicinal product samples published pages: 1231-1246, ISSN: 1743-5889, DOI: 10.2217/nnm-2018-0339	Nanomedicine 14/10	2019-08-01
2019	Christina Giannakou Nanomedicinal products: An integrated approach for immunotoxicity testing published pages: , ISSN: , DOI:		2019-08-30
2019	Christina Giannakou Nanomedicinal products: An integrated approach for immunotoxicity testing published pages: , ISSN: , DOI:		2019-08-01

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The information about "REFINE" are provided by the European Opendata Portal: CORDIS opendata.

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