Project

Overview

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. 

Overall Concept

REFINE RSF will support the current paradigm shift in regulatory science towards testing guided by mechanistic understanding. Based on our already established liaison with the regulatory community we will support harmonisation across regulatory domains and internationally. So, REFINE will support safer, more cost- and time-efficient testing, in a framework that will remain sustainable beyond the project.

 

REFINE literature in Regulatory Science

Project Partners

Key Deliverables

White paper describing the refinement of standard testing methods

Reflection document describing new methods developed to further predict the biological behaviour of new nanomedicines and nanodevices

Reflection document correlating in vitro to in vivo methodologies

Milestones

Knowledge Exchange Conferences

Bridging community and broad dissemination engagement

Dissemination of documents across the stakeholders

ENGAGEMENT AND DIALOGUE WITH COMMUNITIES

Compiled Guidance
structure

IMPACT

REFINE will help to establish a European Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicines with representation from all the stakeholder communities.

REFINE will identify critical issues for innovative products and establishment of an action plan for further studies.

REFINE will deepen existing and establish with existing European Infrastructures along with relevant European Research Networks;

Within REFINE we will elaborate an action plan for a better integration of the European Union with other regions of the world.

REFINE will help to reduce the cost of preclinical and clinical development of NBMs.

REFINE will help to reduce the time for innovations to reach the patients.

REFINE will provide tools for more informed risk assessment and decision-making.

REFINE will help to improve standardisation of regulatory practice at the European and international level.

REFINE will foster close collaboration with the stakeholders communities.