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 NBM used in ATMP and MD.

The risk management framework will consist of:

• Validated methodologies and tools to identify the potential Exposure posed by NBM to humans and the environment.
• Validated methodologies and tools to identify the potential Hazard of NBM to humans and the environment, including a specific strategy for Intelligent Testing (ITS).
• A Tiered Risk Assessment (TRA) for NBM used in ATMP and MD; Risk Management strategies and systems, based on validated methodologies, tools, and guidance, for monitoring and reducing the risks of NBM together with methods for evaluating them.

Within BIORIMA, Empa will develop a material flow model to predict the flows of NBM to the environment.

The project is part of the European Union’s Horizon 2020 framework and has received funding under Grant Agreement 760928.

Website: https://www.biorima.eu/

Publications

Hauser, M.; Nowack, B. (2021) Probabilistic modeling of nanobiomaterials release from medical applications into the environment. Environment International 146: 106184. pdf

Hauser, M.; Nowack, B. (2019) Meta-analysis of pharmacokinetic studies of nanobiomaterials for the prediction of excretion depending on particle characteristics. Frontiers in Bioengineering and Biotechnology 7: 405. (pdf)