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BIORIMA - Development of a reliable methodology for better riskmanagement of engineered biomaterials in Advanced Therapy MedicinalProducts and/or Medical Devices

Tipologia
Progetti internazionali
Programma di ricerca
RIA
Ente finanziatore
H2020
Budget
€ 8761418.75
Periodo
01/11/2017 - 31/10/2021
Prof. Ivana Fenoglio

Partecipanti al progetto

Descrizione del 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.

Note

Bando di ricerca: parte del progetto del Prof. Bergamaschi (Dip.Sc.Sanità Pubblica e Pediatriche)
Ultimo aggiornamento: 25/07/2022 14:45
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