Edinburgh Napier University

  Development of a reliable methodology for better risk management of engineered biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices.

BIORIMA stands for Biomaterial Risk Management. BIORIMA aims to develop an integrated risk management (IRM)
framework for nano-biomaterials (NBM) used in Advanced Therapeutic Medicinal Products (ATMP) and Medical Devices
(MD). The BIORIMA RM 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. 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 NBM to humans and the environment; (iii) A strategy for Intelligent Testing (ITS) and Tiered
Risk Assessment for NBM used in ATMP and MD.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 760928