BIOmaterial RIsk MAnagement

    Project: EU research project

    Project Details

    Description

    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. BIORIMA workplan consists of 7 workpackages covering the major themes: Materials, Exposure, Hazard and Risk. 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.
    AcronymBIORIMA
    StatusActive
    Effective start/end date1/11/1731/10/21
    • Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products

      Giubilato, E., Cazzagon, V., Amorim, M. J. B., Blosi, M., Bouillard, J., Bouwmeester, H., Costa, A. L., Fadeel, B., Fernandes, T. F., Fito, C., Hauser, M., Marcomini, A., Nowack, B., Pizzol, L., Powell, L., Prina-Mello, A., Sarimveis, H., Scott-Fordsmand, J. J., Semenzin, E., Stahlmecke, B. & 6 others, Stone, V., Vignes, A., Wilkins, T., Zabeo, A., Tran, L. & Hristozov, D., 2 Oct 2020, In: Materials. 13, 20, 29 p., 4532.

      Research output: Contribution to journalArticleAcademicpeer-review

      Open Access
      3 Citations (Scopus)