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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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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 FR (PARIS 15) coordinator 1˙090˙625.00
2    SINTEF AS NO (TRONDHEIM) participant 1˙644˙187.00
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    BIOKERALTY RESEARCH INSTITUTE AIE ES (ARCAUTE ALAVA) participant 102˙395.00
14    STIFTELSEN SINTEF 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

year authors and title journal last update
List of publications.
2019 Christina Giannakou, Kukka Aimonen, Louis van Bloois, Julia Catalán, 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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