FENOGLIO I. - Progetto H2020 n. 760928 "BIORIMA" (parte del progetto del Prof. Bergamaschi (Dip.Sc.Sanità Pubblica e Pediatriche)
Progetto 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.