Caring about the future

BIORIMA - BIOmaterial RIsk MAnagement
Coordinator - Lang Tran
CESAM Responsible researcher - Mónica J.B. Amorim
Programme - Horizon 2020 Research and Innovation Programm
Execution dates - 2017-11-01 - 2022-01-31 (51 Months)
Funding Entity - EC - European Commission
Funding for CESAM - 188876 €
Total Funding - 7999981 €
Proponent Institution - Institute Of Occupational Medicine (IOM), United Kingdom
Participating Institutions
Universidade de Aveiro
1. Institute Of Occupational Medicine (IOM), United Kingdom
2. Aarhus Universitet (AU), Denmark
3. European Research Services GMBH (ERS), Germany
4. Reuther Rudolf (ENAS), Germany
5. Consiglio Nazionale Delle Ricerche (ISTEC CNR), Italy
6. Agencia Estatal Consejo Superior Deinvestigaciones Cientificas (CSIC), Spain
7. The University Of Manchester (UNIMAN), United Kingdom
8. Westfaelische Wilhelms-Universitaet Muenster (WWU), Germany
9. Karolinska Institutet (KI), Sweeden
10. Universita Degli Studi Di Torino (UNITO), Italy
11. Eidgenossische Materialprufungs- Und Forschungsanstalt (EMPA), Switzerland
12. Universita Degli Studi Di Roma Tor Vergata (URTV), Italy
13. Heriot-Watt University (HWU), United Kigdom
14. Universite Paris Diderot - Paris 7 (UPDIDEROT), France
15. The Provost, Fellows, Foundation Scholars & The Other Members Of Board Of The College Of The Holy & Undivided Trinity Of Queen Elizabeth Near Dublin (TCD), Ireland
16. Edinburgh Napier University (NAPIER), United Kingdom
17. Wageningen University (WU), The Netherlands
18. Instituto Nacional De Investigaciony Technologia Agraria Y Alimentaria Oa Mp (INIA), Spain
19. Universidade De Aveiro (UA), Portugal
20. Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forschung E.V. (Fraunhofer), Germany
21. National Technical University Of Athens (NTUA), Greece
22. Universita Ca' Foscari Venezia (UNIVE), Italy
23. Institut National De L Environnement Et Des Risques (INERIS), France
24. University Of Leeds, United Kingdom
25. Warrant Group Srl (WG), Italy
26. Bionanonet Forschungsgesellschaft MBH (BNN), Austria
27. Instituto Tecnologico Del Embalaje, Transporte Y Logistica (ITENE), Spain
28. Innovation In Research & Engineering Solutions (IRES), Belgium
29. Asociacion Centro De Investigacion Cooperativa En Biomateriales- Cic Biomagune (CIC), Spain
30. Nanovector Srl (NAV), Italy
31. Colorobbia Consulting Srl (COL), Italy
32. Fin-Ceramica Faenza Spa (FCF), Italy
33. Institut Fur Energie Und Umwelttechnik Ev (IUTA), Germany
34. Royal College Of Surgeons In Ireland (RCSI), Ireland
35. The Electrospinning Company Ltd (TECL), United Kingdom
36. Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA), France
37. Joanneum Research Forschungsgesellschaft Mbh (JRF), Austria
38. Greendecision Srl (GD), Italy
39. Tokyo University Of Science Foundation (TUS), Japan
40. Hong Kong University Of Science And Technology (HKUST), Hong Kong
41. Zhejiang University (ZJU), China (People's Republic Of)

Project Description

BIORIMA aims to develop an Integrated Risk Management (IRM) framework for Nano-Biomaterials (NBM) used in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). The BIORIMA IRM 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. 

The BIORIMA IRM framework will be

  • Robust and readily applicable to past and current generations of NBM because it is built on the large and growing database of evidence and experience of researchers in Nanosafety and Nanomedicine.

  • Flexible, in its modular construction, which can easily integrate new scientific results to address the need of future generations of NBM.

  • Beyond the state of the art for NBM safety by providing an encompassing and consistent framework applicable to both NBM and ENM. Specifically, the integration of knowledge from Nanosafety regarding Exposure/Hazard/Risk will advance the current status of NBM safety considerably. An unified IRM framework for both medicinal and engineered nanomaterials is clearly of tremendous advantage to the standardisation and regulation of these materials . The weight of evidence to support and the transparency in the implementation of the tools/methodologies will undoubtedly make the BIORIMA IRM framework an essential and invaluable contribution to the future development and sustainability of biomaterial technology.

The BIORIMA IRM framework will consist of:

  • Validated methodologies and tools to identify the potential Exposure posed by NBM to humans and the environment.

  • Validated methodologies and tools to identify the potential Hazard of NBM to humans and the environment, including a specific strategy for Intelligent Testing (ITS).

Project webpage

CESAM members on this project

CESAM Funding: UIDP/50017/2020 + UIDB/50017/2020 + LA/P/0094/2020