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.
BIORIMA has a runtime of 4 years, with 41 consortium partners and a project budget of almost 8.000.000 €.
BioNanoNet and Joanneum Research Department HEALTH are part of the BIORIMA consortium and will contribute their expertise to achieve the project goals.
A first BIORIMA pre-meeting of the workpackage leaders took place in December in Amsterdam, the official Kick-off-Meeting will be held in Paris from 19th to 21st February 2018.