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.