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REFINE - Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices

REFINE - Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices

REFINE will pioneer a Regulatory Science Framework (RSF) for the risk-benefit assessment of NBM-based medicinal products and medical devices.

REFINE long-term vision is that the REFINE framework will support:

  • Regulatory science to quickly analyse whether a new NBM raises new challenges to testing.
  • Producers, CRO/CDMOs to design safer products, and more efficient testing & manufacturing.
  • Researchers to meet urgent needs of regulators and define Adverse Outcome Pathways.

Conceptually, REFINE RSF will support the current paradigm shift in regulatory science towards testing guided by mechanistic understanding.

Based on REFINE already established liaison with the regulatory community, the project will support harmonisation across regulatory domains and internationally.

REFINE will support safer, more cost- and time-efficient testing, in a framework that will remain sustainable beyond the project.

SINTEF is a partner in the project.

Consortium:

  • COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES, France (Coordinator)
  • STIFTELSEN SINTEF, Norway
  • EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT, Switzerland
  • RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU, Netherlands
  • JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION, Belgium
  • GESELLSCHAFT FUR BIOANALYTIK MUNSTER EV, Germany
  • THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN, Ireland
  • THE UNIVERSITY OF LIVERPOOL, United Kingdom
  • UNIVERSITY OF BRIGHTON, United Kingdom
  • GREENDECISION SRL, Italy
  • BIOPRAXIS RESEARCH AIE, Spain
  • AMATSIGROUP, France
  • EUROPEAN RESEARCH SERVICES GMBH, Germany

This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 

Published 14 November 2018
Vice President - Marketing

Project duration

01/12/2017 - 30/11/2021