BIOmaterial RIsk MAnagement

Objective

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.

Fields of science

• medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
• engineering and technologynanotechnology
• social sciencessociologygovernancecrisis management
• engineering and technologyindustrial biotechnologybiomaterials
• engineering and technologymaterials engineeringceramics

Keywords

• Integrated Risk Management Framework
• Intelligent Testing Strategy
• Decision Support System
• Safer-by-Design Approach
• Nano-Biomaterials
• Toolbox
• Validated Methods
• Reference Materials Bank

Programme(s)

• H2020-EU.2.1.3. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials Main Programme

Topic(s)

• NMBP-12-2017 - Development of a reliable methodology for better risk management of engineered biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices

Funding Scheme

Coordinator

Participants (39)