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Risultati finali
] In alignment with the Industry Commons initiative, MACRAMÉ will build on the results of Task 1.2 to plan and guide the specific cooperation with and dissemination to related sectors and projects; this task will (a) elaborate concepts for engagement with industry communities and their related policy-informing and –making bodies, standardising (i.e. ISO, CEN, nat. bodies) and harmonising (i.e. OECD) bodies, and related projects (i.e. Horizon 2020/Europe), (b) identify stakeholders and organise workshops, and (c) set-up a strategic MACRAMÉ Engagement Roadmap, which builds on the successful ‘REFINE Knowledge Exchange’- and the ‘NanoHarmony’-engagement-processes, and sets sequence/‘time-dependent’ criteria for the MACRAMÉ communication actions in alignment with WP6. The Roadmap will include a dissemination plan for the data-driven hyperconnectivity and interoperability (WP3), and coordinate the execution of the prescribed communication in other WPs (i.e. concerning standardisation- and harmonisation-bodies). The 1st MACRAMÉ Risk Assessors Summit will be held in collaboration with a WP5-standardisation & harmonisation workshop (M12, hosted by BAuA), to reflect with stakeholders from academia, industry, and regulation and standardisation agencies on (a) the status and needs of the regulatory frameworks for the safety of AdMas during the life-cycle of a product, and (b) how the Project plans contribute to this topic. The 2nd MACRAMÉ Risk Assessor Summit (M36) will discuss the MACRAMÉ results and lessons learned with all relevant stakeholders to propose future actions. It will be held at the OECD (alternatively at LIST or RIVM).
Report on the MACRAMÉ Control Material Library (si apre in una nuova finestra)Task 2.1 will generate and characterise a Control Material Library (CML) for AdMas representative of the MACRAMÉ Use-Cases, including (i) the AdMas (e.g. FLG, MLG, GO, CNTs, PLGA NPs), (ii) representative finished products composed of matrices with/without the incorporated AdMas, (iii) AdMas and finished products subjected to simulated controlled ageing, incineration or pyrolysis, and (iv) materials with known toxicity, possibly belonging to AdMas that will serve as benchmark materials in Task 2.3. The materials will be characterised in their pristine state or after incubation in complex environmental/biological matrices. For the physical-chemical characterisation of the critical attributes of the materials included in the CML, advanced methods (incl. SEM, SEM/EDS, AFM, optical microscopy and their combination toward correlative approaches based on constellation matching algorithms, XPS, SMLS and cryo-TEM, DLS, NTA, EDS or Raman) will be used, and alternative methodologies to the gold standard approaches will be developed; this will allow the characterisation of the following attributes: (i) size, (ii) lateral size, (iii) oxidation state (e.g. for GRM) (iv) physical stability in environmental media and biological fluids, (v) distribution of AdMas in the finished products, and (vi) propensity of AdMas to degradation.
Summary Report about the 1st Risk Assessors Summit (si apre in una nuova finestra)] In alignment with the Industry Commons initiative, MACRAMÉ will build on the results of Task 1.2 to plan and guide the specific cooperation with and dissemination to related sectors and projects; this task will (a) elaborate concepts for engagement with industry communities and their related policy-informing and –making bodies, standardising (i.e. ISO, CEN, nat. bodies) and harmonising (i.e. OECD) bodies, and related projects (i.e. Horizon 2020/Europe), (b) identify stakeholders and organise workshops, and (c) set-up a strategic MACRAMÉ Engagement Roadmap, which builds on the successful ‘REFINE Knowledge Exchange’- and the ‘NanoHarmony’-engagement-processes, and sets sequence/‘time-dependent’ criteria for the MACRAMÉ communication actions in alignment with WP6. The Roadmap will include a dissemination plan for the data-driven hyperconnectivity and interoperability (WP3), and coordinate the execution of the prescribed communication in other WPs (i.e. concerning standardisation- and harmonisation-bodies). The 1st MACRAMÉ Risk Assessors Summit will be held in collaboration with a WP5-standardisation & harmonisation workshop (M12, hosted by BAuA), to reflect with stakeholders from academia, industry, and regulation and standardisation agencies on (a) the status and needs of the regulatory frameworks for the safety of AdMas during the life-cycle of a product, and (b) how the Project plans contribute to this topic. The 2nd MACRAMÉ Risk Assessor Summit (M36) will discuss the MACRAMÉ results and lessons learned with all relevant stakeholders to propose future actions. It will be held at the OECD (alternatively at LIST or RIVM).
Report on Stakeholder Involvement & Knowledge Transfer in the first 18 month (si apre in una nuova finestra)Task 5.2 will establish link to relevant activities and initiatives as the Malta-Initiative, VAMAS, EURL ECVAM, the NanoSafety Cluster projects, EURAMET, the Graphene Flagship, NCI-NCL, and PARC to ensure cooperation on (ongoing) standardisation and harmonisation advancements. Sub-Task 5.2.1: MACRAMÉ Workshops - Three MACRAMÉ Workshops (M12, M22, M34) will give an overview of ongoing harmonisation and standardisation projects in the field of nano- and AdMas. Current needs and issues will be discussed, including opportunities for projects to present their work in open sessions and for expert input in closed sessions. Two virtual workshops and one face-to-face (back-to-back with the 1st MACRAMÉ Risk Assessors Summit) are planned. Sub-Task 5.2.2: Improve Knowledge on Harmonisation & Standardisation activities – [Lead: LIST] This Sub-Task will improve the knowledge of industry, scientists and researchers on the harmonisation and standardisation landscape, processes and impact to increase the visibility of these key initiatives and the involvement of new experts on targeted actions. The different bodies, their respective roles and interactions will be introduced and the steps necessary for the harmonisation and standardisation process explained. The Task will use the training material produced in NanoHarmony on the OECD process of TG development, and further broaden the focus to standardisation and validation topics. OECD, ISO, CEN, ASTM, VAMAS and EURL ECVAM representatives will be invited to give insights and thus raise awareness of harmonisation and standardisation processes. Five MACRAMÉ Webinars (M12, M17, M24, M28, M35) will be held, as well as several sessions at summer schools and relevant meetings.
Sampling & Sample-Provision Protocols for AdMas in complex Matrices (si apre in una nuova finestra)Based on the collaboratively re-fined R&I Strategy and its benchmarks, Task 4.1 will define and agree sampling protocols tailored to the exposure points, and the test requirements (e.g. blinding for validation studies (LIST)), and will collect and deliver the required quantities of material to the WP2 partners for investigation and characterisation: Sub-Task 4.1.1: Develop & refine AdMa@CM Sampling & Sample-Provision Protocols (M02–M34) - Sampling and sample-provision protocols for AdMas and AdMa-bearing composites (i.e. AdMa@CM), as well as other relevant control samples, will be developed and implemented, in agreement with WP2 partners; these will be based on the specific Exposure Points conditions (see Figure 3). Subtask 4.1.2: Collect and deliver Use-Case Samples (M02-34) - Industrial partners will provide both pristine materials as used in their products, and samples collected from selected release hotspots to provide a representative selection of the value-chains (e.g. consumer use and end-of-life (incineration and landfilling)), following all special requirements for sample collection and preparation, ensuring sufficient material is delivered for characterisation, analysis and evaluation in WP2.
A Project Corporate Identity (CI) will be developed; it will be composed of a Project logo, the layout for flyers and website, a template for presentations, and a layout for the Project’s newsletters. The website will be launched in M01 (initial Project website), later updated to a full website in M05. Printed and digital means will be used for targeted communication and dissemination (Section 2.2).
This Task will provide a one-stop-shop for harmonised and interoperable MACRAMÉ (Meta)Data-Exchange with all customised tools for curation, storing and sharing: the provision will be made in two parts: (i) Providing, integrating and customising tools for information management and sharing, (electronic lab notebooks, instance maps & data packages) optimised for different tasks & users: All tools will be adapted to address the requirements of the improved reporting guidelines developed in Task 3.2. Advanced cloud technology will allow collaborative research on multiple levels (e.g., within single or multiple-partner teams, for case-study and/or round-robin work) in a secure and traceable way. (ii) Direct linking to analysis and modelling software from Task 3.3 and 3.4 and standard data resources for long-term storage and FAIR sharing of data: in collaboration with Task 3.2, MACRAM’s data concepts and guidance will be implemented in the form of extended reporting and exchange formats (machine-readable, semantically annotated) interoperable and aligned with major European Initiatives (IndustryCommons, EU NanoSafety Cluster and European Materials Characterisation Council). Automatic data upload to standard repositories (NanoCommons, eNanomapper, CHADA repositories) will be possible, initiated by the data owner. The data-management and -sharing processes adopted by the MACRAMÉ consortium will be documented and constantly updated in the research output management plan (ROMP), an extension of a DMP, which will guide partners in their preparation of technology documentation, protocols, (meta)data, software and results. The ROMP will also provide measures for addressing problems or challenges encountered in data curation and management.
Pubblicazioni
Autori:
F. R. Cassee et al.
Pubblicato in:
Computational and Structural Biotechnology Journal, Numero 25, 2024, ISSN 2001-0370
Editore:
Elsevier
DOI:
10.1016/j.csbj.2024.05.018
Autori:
I. Furxhi et al.
Pubblicato in:
RSC Sustainability, Numero 1, 2023, ISSN 2753-8125
Editore:
RSC
DOI:
10.1039/d2su00101b
Autori:
Eric A.J. Bleeker, Elmer Swart, Hedwig Braakhuis, María Luisa Fernández Cruz, Steffi Friedrichs, Ilse Gosens, Frank Herzberg, Keld Alstrup Jensen, Frank von der Kammer, Jolinde A.B. Kettelarij, Jose María Navas, Kirsten Rasmussen, Kathrin Schwirn, Maaike
Pubblicato in:
Regulatory Toxicology and Pharmacology, 2023, ISSN 0273-2300
Editore:
Academic Press
DOI:
10.1016/J.YRTPH.2023.105360
Autori:
Gupta et al.
Pubblicato in:
Small, Numero 20, 2024, ISSN 1613-6829
Editore:
Wiley
DOI:
10.1002/smll.202308148
Autori:
Punz et al.
Pubblicato in:
Beilstein Archives, 2024, ISSN 2190-4286
Editore:
Beilstein-Institut Zur Forderung der Chemischen Wissenschaften
DOI:
10.3762/bxiv.2024.26.v1
Autori:
T. E. Exner et al.
Pubblicato in:
Frontiers in Physics, Numero 11, 2023, ISSN 2296-424X
Editore:
Frontiers Media
DOI:
10.3389/fphy.2023.1233879
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