ASOCIACION CENTRO DE INVESTIGACION COOPERATIVA EN BIOMATERIALES- CIC biomaGUNE
Organization address
address: PASEO MIRAMON 182, PARQUE TECNOLOGICO DE SAN SEBASTIAN EDIFICIO EMPRESARIAL C
city: SAN SEBASTIAN
postcode: 20009
website: www.cicbiomagune.es
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.
Monopoli, Marco; Moros, MarÃa Protein corona of NBMs published pages: , ISSN: , DOI:
1
2020-03-09
2019
Ida Kokalari, Riccardo Gassino, Andrea M. Giovannozzi, Luca Croin, Elena Gazzano, Enrico Bergamaschi, Andrea M. Rossi, Guido Perrone, Chiara Riganti, Jessica Ponti, Ivana Fenoglio Pro- and anti-oxidant properties of near-infrared (NIR) light responsive carbon nanoparticles published pages: 165-176, ISSN: 0891-5849, DOI: 10.1016/j.freeradbiomed.2019.01.013
Free Radical Biology and Medicine 134
2020-03-09
Are you the coordinator (or a participant) of this project? Plaese send me more information about the "BIORIMA" project.
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Send me an email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.
Thanks. And then put a link of this page into your project's website.
The information about "BIORIMA" are provided by the European Opendata Portal: CORDIS opendata.
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