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BIOmaterial RIsk MAnagement

BIOmaterial RIsk MAnagement

Objective

BIORIMA stands for Biomaterial Risk Management. BIORIMA aims to develop an integrated risk management (IRM) framework for nano-biomaterials (NBM) used in Advanced Therapeutic Medicinal Products (ATMP) and Medical Devices (MD). The BIORIMA RM framework is a structure upon which the validated tools and methods for materials, exposure, hazard and risk identification/assessment and management are allocated plus a rationale for selecting and using them to manage and reduce the risk for specific NBM used in ATMP and MD. Specifically, the IRM framework will consist of: (i) Risk Management strategies and systems, based on validated methodologies, tools, and guidance, for monitoring and reducing the risks together with methods for evaluating them; (ii) Validated methodologies and tools to identify the potential Exposure and Hazard posed by NBM to humans and the environment; (iii) A strategy for Intelligent Testing (ITS) and Tiered Risk Assessment for NBM used in ATMP and MD. BIORIMA workplan consists of 7 workpackages covering the major themes: Materials, Exposure, Hazard and Risk. BIORIMA will generate methods and tools for these themes for use in risk evaluation and reduction. The BIORIMA toolbox will consist of validated methods/tools for materials synthesis; reference materials bank; methods for human/environment exposure assessment and monitoring; (eco)-toxicology testing protocols; methods for prevention of accidental risks – massive release or explosion – A tiered risk assessment method for humans/environment; An intelligent testing strategy for NBM and risk reduction measures, including the safer-by-design approach. BIORIMA will deliver a web-based Decision Support System to help users, especially SME, evaluate the risk/benefit profile of their NBM products and help to shorten the time to market for NBM products.
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Coordinator

INSTITUTE OF OCCUPATIONAL MEDICINE

Address

Research Avenue North, Riccarton 45
Eh14 4ap Edinburgh

United Kingdom

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 391 453,75

Participants (40)

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AARHUS UNIVERSITET

Denmark

EU Contribution

€ 341 251,25

EUROPEAN RESEARCH SERVICES GMBH

Germany

EU Contribution

€ 226 222,50

REUTHER RUDOLF

Germany

EU Contribution

€ 176 750

CONSIGLIO NAZIONALE DELLE RICERCHE

Italy

EU Contribution

€ 310 950

AGENCIA ESTATAL CONSEJO SUPERIOR DEINVESTIGACIONES CIENTIFICAS

Spain

EU Contribution

€ 216 275

THE UNIVERSITY OF MANCHESTER

United Kingdom

EU Contribution

€ 217 636,25

WESTFAELISCHE WILHELMS-UNIVERSITAET MUENSTER

Germany

EU Contribution

€ 242 953,75

KAROLINSKA INSTITUTET

Sweden

EU Contribution

€ 362 393,75

UNIVERSITA DEGLI STUDI DI TORINO

Italy

EU Contribution

€ 187 702,50

EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT

Switzerland

EU Contribution

€ 324 750

UNIVERSITA DEGLI STUDI DI ROMA TOR VERGATA

Italy

EU Contribution

€ 234 456,25

HERIOT-WATT UNIVERSITY

United Kingdom

EU Contribution

€ 244 065

UNIVERSITE PARIS DIDEROT - PARIS 7

France

EU Contribution

€ 245 337,50

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

€ 265 596,25

EDINBURGH NAPIER UNIVERSITY

United Kingdom

EU Contribution

€ 208 225

WAGENINGEN UNIVERSITY

Netherlands

EU Contribution

€ 284 188,75

INSTITUTO NACIONAL DE INVESTIGACION Y TECNOLOGIA AGRARIA Y ALIMENTARIA OA MP

Spain

EU Contribution

€ 159 475

UNIVERSIDADE DE AVEIRO

Portugal

EU Contribution

€ 188 876,25

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Germany

EU Contribution

€ 235 671,25

NATIONAL TECHNICAL UNIVERSITY OF ATHENS - NTUA

Greece

EU Contribution

€ 203 125

UNIVERSITA CA' FOSCARI VENEZIA

Italy

EU Contribution

€ 195 387,50

INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS

France

EU Contribution

€ 187 426,25

UNIVERSITY OF LEEDS

United Kingdom

EU Contribution

€ 226 335

WARRANT HUB SPA

Italy

EU Contribution

€ 208 000

BIONANONET FORSCHUNGSGESELLSCHAFT MBH

Austria

EU Contribution

€ 101 990

INSTITUTO TECNOLOGICO DEL EMBALAJE, TRANSPORTE Y LOGISTICA

Spain

EU Contribution

€ 205 106,25

INNOVATION IN RESEARCH & ENGINEERING SOLUTIONS

Belgium

EU Contribution

€ 121 875

ASOCIACION CENTRO DE INVESTIGACION COOPERATIVA EN BIOMATERIALES- CIC biomaGUNE

Spain

EU Contribution

€ 220 025

NANOVECTOR SRL

Italy

EU Contribution

€ 83 521,25

COLOROBBIA CONSULTING SRL

Italy

EU Contribution

€ 83 521,25

FIN-CERAMICA FAENZA SPA

Italy

EU Contribution

€ 83 521,25

INSTITUT FUR ENERGIE UND UMWELTTECHNIK EV - IUTA

Germany

EU Contribution

€ 225 375

ROYAL COLLEGE OF SURGEONS IN IRELAND

Ireland

EU Contribution

€ 236 096,25

THE ELECTROSPINNING COMPANY LTD

United Kingdom

EU Contribution

€ 83 236,25

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

France

EU Contribution

€ 190 692,50

JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH

Austria

EU Contribution

€ 158 803,75

GREENDECISION SRL

Italy

EU Contribution

€ 121 713,75

TOKYO UNIVERSITY OF SCIENCE FOUNDATION

Japan

HONG KONG UNIVERSITY OF SCIENCE AND TECHNOLOGY

Hong Kong

Zhejiang University

China

Project information

Grant agreement ID: 760928

Status

Ongoing project

  • Start date

    1 November 2017

  • End date

    31 October 2021

Funded under:

H2020-EU.2.1.3.

  • Overall budget:

    € 8 761 418,75

  • EU contribution

    € 7 999 981,25

Coordinated by:

INSTITUTE OF OCCUPATIONAL MEDICINE

United Kingdom