New Approach Methodologies (NAM)-supported read-across (RAX): from case studies to regulatory guidance in safety assessment. The workshop took place at Hotel Korpilampi in Espoo, Finland, on 21-22 May 2019. EU-ToxRisk_Read-across workshop_description and preliminary agenda [PDF]
EU-ToxRisk project: The project aims to develop and implement new approach methodologies (NAMs) as an alternative approach for the safety testing of chemicals. EU-ToxRisk assembled wide panel of the state-of-the-art in silico and in vitro test methods, which allow for the testing of systemic repeated dose target organ toxicity (RDT), covering liver, kidney, lung and neuronal system as target organs, as well as experimental systems that cover developmental and reproductive toxicity (DART). The objective is to assess the application of NAMs as a tool to improve read-across, as well as in the context of ab initio chemical safety assessment.
Focus & main objective: The workshop focuses on several scientifically advanced project case studies
developed within the EU-ToxRisk project, the OECD/IATA program, and NIHS Japan. Case studies are
discussed with regard to their applicability to different regulatory requirements e.g. in Europe (e.g. REACH,
EU Pesticides) and global (Canada Chemicals Management Plan and Japanese Chemical Substances of Control Law). Stakeholders from academia, industry, and authorities will work together to improve their
understanding of each other needs and come to a mutual agreement on the principles of NAM informed risk assessment.
The overall aim is to include the outcome of the event discussions in an improved regulatory guidance document for NAM-supported RAX. Furthermore, the EU-ToxRisk team plans to disseminate a refined read-across template for the toxicological community. This will improve the quality of the submission of read-across cases by registrants, and by this it will increase the success rate of non-animal safety approaches.
Target group & Event format: The workshop is open to experts of the field coming from regulatory agencies, industry, and academia, thus providing an exceptional forum for knowledge exchange.
After a short introduction, break out groups will thoroughly discuss the individual case studies under the
direction of the chairs. The case studies are seen as examples and the workshop aims to identify and extract those general approaches and learnings that will help in future NAM guided read-across approaches.
Please, take a look at the below preliminary agenda to get a clearer picture of how the described format will be put into practice and around which case studies.
Registration & Linked costs: The event is open to a limited number of participants to allow an efficient and fruitful discussion. Registration is thus mandatory. The registration website is currently being prepared and registration will be launched in the first week of March. You will receive an e-mail notification with appropriate instructions, once the website is up and running.
There will be no registration fee. However, a special meeting package covering lunch and coffee breaks on
both days will be automatically added to your hotel bill (~57 Euro/day).
Reimbursement: As EU-Toxrisk benefits from public funds, the budget for organising the workshop is limited. Reimbursement of travel costs and lodging can thus not be guaranteed, and the organisers thank you for your understanding.
The whole organization committee, represented by its chair Susanne Hougaard Bennekou (DTU; EU-ToxRisk partner) and co-chair Bob van de Water (UL, EU-ToxRisk coordinator), look forward to welcoming you to this pivotal event.