Development of the scientific basis for OECD TGs
NanoHarmony developed the scientific basis towards OECD TGs/GDs for eight regulatory endpoints this included literature research on available data, development and validation of SOPs and regular expert consultations. The scientific work was documented in several publicly available deliverables and publications to keep the scientific and regulatory community up-to-date. The outcomes were presented during several expert meetings, workshops and international conferences.
Support for a smooth and effective test method development
The present OECD TG development process was assessed by compiling an awareness strategy plan. This includes a detailed process description for validation and the timelines leading to the formal acceptance by OECD. Stakeholders were consulted via an online survey that gained input from regulators, industry, developers and users of OECD TGs. The results of the anonymous survey together with insights gained during interviews, webinars and workshops provided insights in the obstacles and challenges along the TG development process from different perspectives. A major hurdle identified was lack of knowledge on the TG development process. To address this, NanoHarmony developed freely available Training Material, that provides a low-level entry into the topic. To provide more in-depth guidance, NanoHarmony developed the OECD TG Process Mentor, an interactive web-based guidance tool for TG development. Recommendations to further streamline the processes of OECD TG developments were captured in the NanoHarmony White Paper that is publicly available and was actively advertised.
Cooperation - Expert and stakeholder networks
Cooperation was a central tool of NanoHarmony and was crucial for achieving its goals, namely development of OECD TGs/GDs as well as developing process improvements. Strong cooperation with the NMBP-34 sister project NANOMET, OECD, the MI, the EU NanoSafety Cluster and other EU-funded projects was initiated and established. The established high-profile network includes scientific experts, stakeholders from industries, contract research organisations, regulators, different EU-projects, in Europe and beyond (e.g. through the NanoHarmony Associated Partners). As such, the network ensures a high integration of different knowledge carriers and stakeholders. For each endpoint, expert groups including OECD experts met regularly. Three international online workshops were held in November 2020, 2021 and 2023. These workshops plus the eight webinars were used to reach out to a broad audience of different international stakeholders. Stakeholders were kept up to date by regular newsletters.
To further support future TG development, NanoHarmony cooperated with the MI and AMI2030 in bringing the topic further to the attention of policy makers. Activities included contributions in writing the MI Position Paper and the publication of a White Paper. NanoHarmony organised the Policy Meeting “European Safety and Sustainability Assessment: Fit for the Future” that contributed to informing key stakeholders, especially policy makers, of the importance of OECD TG development. Additionally, this meeting showed the achievements made by NanoHarmony in this area, while suggesting how the legacy of the project should be taken forward into a proposed European Test Methods Strategy.
