Nano-Biomaterial Risk Management

The EU H2020 BIORIMA project is one of the first and largest European initiatives that is totally dedicated to the development of innovative and robust methodologies to assess and manage the risks of nano-biomaterials (NBM) that are used in medical devices and advanced medicinal therapy products, along their whole life cycle, and at the same time identify and implement suitable safety-by-design alternatives. The BIORIMA consortium is implementing a comprehensive method testing and validation program to adapt and further develop existing tools for human and environmental exposure and hazard assessment of NBM, beyond clinical studies. All approaches that are tested and developed are integrated into a risk management framework (RMF) to help practitioners and end-users in finding best practical solutions for testing and handling of NBM. The RMF will be implemented by means of a web-based and specially designed Decision Support System (DSS), to comply with existing relevant regulations, such as MDR 2017/745 or REACH. The poster describes the latest findings of the project after 3 years of intensive research on the hazard of NBM and of the underlying mechanisms that are crucial for the effects and exposure we observe in humans and the environment.