Risultati finali
The final softwareimplemented DSS including user guide will be tested on the selected case studies on 3 representatives nanomaterials Lipidots PACA and gold nanoparticles The accompanying documentation will include data from the DSS application to the study cases At least 20 prospective DSS users will be invited to a workshop for targeted training selected in interaction with WP6
REFINE user communitiesTwo communities of active contributors each of about 12 members strong will be established They will cocreate the DSS in particular the interface and options to add users preferences and will support WP 25 by offering methodsprocedures for the WP2 inventory andor participate in interlaboratory comparisons
First beta version DSSWe will arrange a workshop where approximately 20-25 stakeholders (regulators, industry, academia) are invited to inspect and interact with the early version of the DSS, including example data sets for input. This will give valuable feedback on adjustments of the DSS to users' needs and wishes.
Knowledge-HUB (K-HUB: Social media strategy implementation, explicit knowledge sharing repository)This online platform should provide access to all non-confidential REFINE results. The platform should be searchable and allow filtering, contributions and -if deemed useful- opportunities to engage in online discussions. We will make use of the glossary of terminology to appeal to various stakeholder communities.
REFINE final KECAn international event with participation form all relevant stakeholder communities nonEU world regions and policy makersresearch funding programmes
We will arrange a workshop where approximately 20-25 stakeholders (regulators, industry, academia) are invited to inspect and interact with the early version of the DSS, including example data sets for input. This will give valuable feedback on adjustments of the DSS to users' needs and wishes.
Progress report on the use of the whitepaper in community discussions, in particular the Knowldege Exchange Conferences, and the feed in to various knowledge bases used for regulatory purposesWe will review whether the whitepaper works as kernel for a sustained dialoge of regulators scientists and developers
Two workshops with strong participation from regulatorsTwo workshops will be organised with at least 15 external participants each, from regulatory bodies and expert-level scientific committees related to regulatory bodies, plus additional high-level participants from research and development.
Reflection DocumentA reflection document will present the outline of the methodology to design intelligent testing strategies, considerations regarding populating the repository and ranking methods according to product and measurand, current observations on CQAs, as well as approaches and structures intended for the DSS. This document will serve both as an internal orientation and as a foundation for interaction with external stakeholders as it will feed into the whitepaper-drafting in WP1.
Guidance Manual for stakeholdersThe Guidance Manual will include the methodology to design intelligent testing strategies the inventory of testing methods and procedures and the CQA recommendations The development of the DSS will also be described The format will be targeted towards all relevant stakeholders
Report outlining the transferability of the in silico approach together with the linked in vitro assaysThe report outlines the outcome of the test for transferability of the in silico approach together with the linked in vitro assays which is based on an interlaboratory comparison The report also includes the comprehesive statistical analysis of all the results together with the collection of the SOPs of the in silico approach and of all standardised in vitro assays used in this context
First draft of whitepaperThe draft whitepaper will propose a catalogue of information requirements and needs for harmonisation (e.g. to address borderline products that fall under different legislature in different world regions). It will propose a gap analysis, where scientific state of the art and regulatory practice seem out of step (e.g. present a list of major adversities of administered NBMs described in the scientific literature, that are hard to predict by current standard testing methods). Thirdly the document will propose a heuristic how to assimilate new evidence in reliable and efficient way into regulatory strategies (e.g. which testing methods would deliver information that supports the modeling of an NMB-specific Adverse Outcome Pathway, for example for CARPA ).
Report on inventory of testing methods and -proceduresThe statusquo of the repository with integrated ranking Task 22 will be reported in this deliverable This deliverable marks the start of consolidating the inventory within the methodology for intelligent testing architectures at the same time the deliverables serves as check whether we inspired a critial contribution from stakeholders information about testing methods performance and access to protocols that could be used in the inventory
Report on in vitro characterization of nanoparticle distributionReport on the quantitative evaluation of key variables such as apparent permeability through various barriers systems, or uptake kinetics in key cell populations
List of requirements for any method re eligibility for regulatory acceptance/ standardisationThe report summarizes the outcome of the interlaboratory comparison which tests the transferability of the involved methods The report also includes the comprehesive statistical analysis of all the results together with the collection of the SOPs
Pubblicazioni
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Three-dimensional (3D) liver cell models - A tool for bridging the gap between animal studies and clinical trials when screening liver accumulation and toxicity of nanobiomaterials
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Editore:
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B. Halamoda-Kenzaoui, R.J. Vandebriel, A. Howarth, M. Siccardi, C.A.W. David, N.J. Liptrott, M. Santin, S.E. Borgos, S. Bremer-Hoffmann, F. Caputo
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Autori:
Lead beneficiary: SINTEF
Pubblicato in:
2018
Editore:
REFINE Project
Autori:
Lead beneficiary: GreenDecision
Pubblicato in:
2020
Editore:
REFINE Project
Autori:
Lead beneficiary: Joint Research Center
Pubblicato in:
2019
Editore:
REFINE Project
Autori:
Lead beneficiary: Joint Research Center
Pubblicato in:
2018
Editore:
REFINE Project
Autori:
Lead beneficiary: University of Liverpool
Pubblicato in:
2019
Editore:
REFINE Project
Autori:
B. HALAMODA-KENZAOUI, H. BOX,
M. VAN ELK,
S. GAITAN,
R. GEERTSMA,
E. GAINZA LAFUENTE,
A. OWEN, A. DEL POZO, M.
ROESSLEIN, S.
BREMER- HOFFMANN
Pubblicato in:
2019, ISSN 1831-9424
Editore:
Publications Office of the European Union
DOI:
10.2760/596822
Autori:
Valeria Perugini, Matteo Santin
Pubblicato in:
Chinese-European Societies for Biomaterials Conference, 2019
Editore:
Chinese Society for Biomaterials (CSBM) and European Society for Biomaterials (ESB)
Autori:
Kai Eder, Anne Marzi, Álvaro Barroso, Björn Kemper, Jürgen Schnekenburger
Pubblicato in:
Quantitative Phase Imaging VII; 116531Q, Numero Proceedings Volume 11653, 2021
Editore:
SPIE
DOI:
10.1117/12.2577655
Autori:
Valeria Perugini, Matteo Santin
Pubblicato in:
30th European Society for Biomaterials Conference, 2019, Pagina/e III-OS10-05 page 188
Editore:
European Society for Biomaterials
Autori:
Kai Moritz Eder, Anne Marzi, Alvaro Barroso, Björn Kemper, and Jürgen Schnekenburger
Pubblicato in:
Imaging and Applied Optics Congress, OSA Technical Digest, Numero Imaging and Applied Optics Congress, OSA Technical Digest (Optica Publishing Group, 2020), paper JW5A.4., 2020
Editore:
OSA
Autori:
Kai Eder, Tobias Kutscher, Anne Marzi, Álvaro Barroso, Jürgen Schnekenburger, Björn Kemper
Pubblicato in:
Label-free Biomedical Imaging and Sensing, 2021
Editore:
SPIE
DOI:
10.1117/12.2577232
Autori:
Tobias Kutscher, Kai Eder, Anne Marzi, Álvaro Barroso, Jürgen Schnekenburger, and Björn Kemper
Pubblicato in:
OSA Optical Sensors and Sensing Congress 2021, Numero OSA Technical Digest (Optica Publishing Group, 2021), paper JTu5A.23., 2021
Editore:
OSA
Autori:
Matteo Santin (Invited Keynote Speaker)
Pubblicato in:
Tissue Engineering and Regenerative Medicine International Societies (TERMIS) 2019, 2019, Pagina/e 726
Editore:
TERMIS
Autori:
Kemper B., Barroso Á., Eder K., Marzi A., Ritz S., Schnekenburger J., Ketelhut S.
Pubblicato in:
2021
Editore:
Progress in Biomedical Optics and Imaging - Proceedings of SPIE
DOI:
10.1117/12.2577807
Autori:
Björn Kemper, Álvaro Barroso, Kai Eder, Anne Marzi, Sabrina Ritz, Angelos Ntovas, Jürgen Schnekenbürger, Steffi Ketelhut
Pubblicato in:
Proceedings Volume 11786, Optical Methods for Inspection, Characterization, and Imaging of Biomaterials V; 117860I (2021), Numero SPIE Optical Metrology, 2021, 2021
Editore:
SPIE
DOI:
10.1117/12.2592534
Autori:
Kai Moritz Eder
Pubblicato in:
2021
Editore:
XXX
Autori:
Christina Giannakou
Pubblicato in:
2019
Editore:
Maastricht University
Autori:
Kathleen Spring, Klaus-Michael Weltring, Adriele Prina-Mello, Ruth Schmid
Pubblicato in:
Drug Delivery and Translational Research, 2022, ISSN 2190-393X
Editore:
Springer Pub. Co.,
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