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BIOmaterial RIsk MAnagement

Ziel

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.

Wissenschaftliches Gebiet

Schlüsselbegriffe

Programm/Programme

Thema/Themen

Aufforderung zur Vorschlagseinreichung

H2020-NMBP-2016-2017

Andere Projekte für diesen Aufruf anzeigen

Unterauftrag

H2020-NMBP-2017-two-stage

Finanzierungsplan

RIA - Research and Innovation action

Koordinator

INSTITUTE OF OCCUPATIONAL MEDICINE
Netto-EU-Beitrag
€ 391 453,75
Adresse
Research Avenue North, Riccarton 45
EH14 4AP Edinburgh
Vereinigtes Königreich

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KMU

Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen).
Ja
Region
Scotland Eastern Scotland Edinburgh
Aktivitätstyp
Research Organisations
Links
Gesamtkosten
€ 391 453,75

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Letzte Aktualisierung: 8 Dezember 2023

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Permalink: https://cordis.europa.eu/project/id/760928/de

European Union, 2024