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Dear ETPN members, dear colleagues from the European community of Nanomedicine, it is our pleasure to highlight today a great innovation developed by the H2020 REFINE Project: an open Decision Support System for cost efficient preclinical assessment of nanomedicine products. In this article you learn more about this unique tool to accelerate and improve the translation to the clinic of your nanomedicine innovations, and are invited to an on-line training course on the use of the REFINE DSS to be held on December 15, 2021.

What is the REFINE Decision Support System?

The REFINE DSS has been developed to support experts, innovators and regulators in the implementation of Intelligent Testing Strategies for cost efficient preclinical assessment of nanotechnology based medicinal products and medical devices. The ITS consist of testing methods and modelling approaches for the characterisation of the physicochemical properties of nanomedicine products.

On the basis of the provided input parameters, such as

  • the description of the nanotechnology based medicinal products and medical devices
  • their intended use
  • the available information on the structure of the nanotechnology based system (e g layers composition, core composition, etc APIs, excipients, buffers and impurities

the DSS guides the user through the physicochemical characterization of the nanotechnology based health product by recommending specific assays and prioritizing them according to several parameters, such as cost, duration and required expertise to run the assay.

The REFINE DSS is available here: https://www.refinedss.eu/

Register for the REFINE DSS Training course!

REFINE offers a free on-line training course on the use of the REFINE DSS: hands-on session on the Physical-Chemical module of the REFINE DSS along a case study.

  • Date: 15th of December 2021, starting at 11.00 -13.00 CET
  • Free Registration: accessible here.
  • An event led by GreenDecision.

Program of the training course

  • 11.00 –11.15. Introduction to REFINE project Dr. Kathleen Spring (Managing Director at BioanalytikMuenster / REFINE Coordinator and Vice-chair of the ETPN)
  • 11.15 –11.30. Reasoning behind the development of the REFINE DSS Dr. Sven Even Borgos (SINTEF)
  • 11.30 –12.10. Presentation of the Physical-Chemical module of the REFINE DSS. Dr. Alex Zabeo (Green Decision srl)
  • 12.10 –12.30. Hand-on the Physical-Chemical module of the REFINE DSS. Dr. Alex Zabeo (Green Decision srl). Attendants will follow the instruction of the trainer to perform a specific case study.
  • 12.30 –12.50. Discussion and open questions Dr. Lisa Pizzol (Green Decision srl).
  • 12.50 –13.00. Summary and Conclusions. Dr. Danail Hristozov (Green Decision srl)

About REFINE

The REFINE project (http://refine-nanomed.eu/) has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no 761104. REFINE project aims at setting up a Regulatory Science Framework ( RSF ) for the risk benefit assessment of NBM based medicinal products and medical devices.  REFINE will support safer, more cost and time efficient testing, in a framework that will remain sustainable beyond the project.

Objectives

  1. Identification of regulatory challenges and existing gaps to address them;
  2. Transform regulatory challenges and gaps into development of new assays that will provide the missing data needed in the regulatory dossiers;
  3. Rationalise testing and refine testing methods to answer to the currents most pressing regulatory concerns;
  4. Development of a Decision Support System which implements an intelligent testing strategy for nano bio materials;
  5. Assure quality standards for development and testing;
  6. Bridge communities: to make information and exchange possible

Save the date: 3rd. REFINE KEC to be held in next January!

We at the ETPN highly recommend that you participate also in the REFINE Project 3rd. Knowledge Exchange Conference (KEC3), which will take place on the 26th-27th of January 2022 notably online. More info by clicking here.