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BIOmaterial RIsk MAnagement

Objetivo

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.

Ámbito científico

CORDIS clasifica los proyectos con EuroSciVoc, una taxonomía plurilingüe de ámbitos científicos, mediante un proceso semiautomático basado en técnicas de procesamiento del lenguaje natural.

Convocatoria de propuestas

H2020-NMBP-2016-2017

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Convocatoria de subcontratación

H2020-NMBP-2017-two-stage

Régimen de financiación

RIA - Research and Innovation action

Coordinador

INSTITUTE OF OCCUPATIONAL MEDICINE
Aportación neta de la UEn
€ 391 453,75
Dirección
RESEARCH PARK NORTH RICCARTON
EH14 4AP EDINBURGH
Reino Unido

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Pyme

Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.

Tipo de actividad
Research Organisations
Enlaces
Coste total
€ 391 453,75

Participantes (39)