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.
Fields of science
Keywords
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
EH14 4AP Edinburgh
United Kingdom
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Participants (39)
8000 Aarhus C
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48149 Muenster
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00185 Roma
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28006 Madrid
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M13 9PL Manchester
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48149 MUENSTER
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17177 Stockholm
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10124 Torino
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8600 Dubendorf
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00133 Roma
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EH14 4AS Edinburgh
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75006 Paris
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D02 CX56 DUBLIN 2
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EH14 1DJ Edinburgh
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6708 PB Wageningen
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3810-193 Aveiro
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80686 Munchen
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157 80 ATHINA
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30123 Venezia
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60550 Verneuil En Halatte
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LS2 9JT Leeds
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42015 Correggio Re
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
8010 Graz
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46980 Paterna
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1030 SCHAERBEEK
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
20009 San Sebastian
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10144 Torino
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
50053 Sovigliana
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48018 Faenza
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47229 Duisburg
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2 Dublin
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OX11 0QX Didcot
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
75015 PARIS 15
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8010 Graz
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30121 VENEZIA
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Tokyo
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999077 Hong Kong
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310027 HANGZHOU
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