BIORIMA - Nov 2017 – Jan 2022

Project Details: BIOmaterial RIsk MAnagement

Specific challenge: 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).

Scope: 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.

Expected Impact: 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 NBM 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 NBM products and help to shorten the time to market for NBM products.

Funded under:

INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials

Overall budget € 8,761,418.75 (EU contribution 7,999,981.25)

TCD PI: Dr Adriele Prina-Mello, TTMI, School of Medicine

TCD budget: € 265,596.25

Weblink at European Commission portal: https://cordis.europa.eu/project/id/760928

Results and outcomes available at: https://cordis.europa.eu/project/id/760928/results