BIORIMA - BIOmaterial RIsk Management
BIORIMA project has received funding from the European Union’s HORIZON 2020 research and innovation programme under grant agreement n° 260928.
Project duration: 01 11 2017 - 31 10 2021 (48 months)
Total cost: EUR 8.761.418,75
EU contribution: EUR 7.999.981,25
Number of partners: 41 (including coordinator)
BNN members participating in BIORIMA: JOANNEUM RESEARCH, Department HEALTH
Coordinator: Institute of Occupational Medicine, UK
Project keywords: Biomaterials (as related to medical implants, devices, sensors), Integrated Risk Management Framework, Intelligent Testing Strategy, Decision Support, System, Safer-by-Design Approach, Nano-Biomaterials , Toolbox, Validated Methods, Reference Materials Bank
Project summary & objectives:
The EU funded H2020 Research and Innovation action BIORIMA started with beginning of November 2017. The acronym BIORIMA stands for Biomaterial Risk Management. The project aims to develop an integrated risk management framework for nano-biomaterials used in advanced therapeutic medicinal products and medical devices. The BIORIMA risk management 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 nano-biomaterials used in medical applications.
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 nano-biomaterials to humans and the environment;
(iii) A strategy for intelligent testing and tiered risk assessment for nano-biomaterials used in medical applications.
The 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 nano-biomaterials 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 nano-biomaterials and help to shorten the time to market for their products.
Role of BNN: