Webinar Series Overview
On March 28, 2023, the European Chemical Agency (ECHA) released its final report of the Extended One Generational Reproductive Toxicity Study (EOGRTS) review project. The project reviewed EOGRT studies conducted under OECD 443 and identified critical aspects in study design.
Across four webinars we explore the issues identified by ECHA in the review project, how it could affect your research, and provide recommendations and best practices to follow. Q&A sessions with our leading DART scientists will be included in the sessions.
Final Report: ECHA’s EOGRTS Review Project
On March 28, 2023, ECHA released its Final Report of the Extended One Generational Reproductive Toxicity Studies (EOGRTS) Review Project. As part of this project, ECHA evaluated methods and results from 55 EOGRT studies submitted under REACH. In its final report, ECHA provides several recommendations for good practices for test laboratories and registrants. Additionally, in 2022, ECHA published advice for registrants on the selection of appropriate dose levels based on their conclusion that in 20% of evaluated EOGRT studies, selected dose levels were too low. This led to studies being considered inconclusive for classification and labelling, resulting in a need for repeated testing.
In this webinar, you will explore the impacts, recommendations, and best practices outlined in ECHA’s report followed by a live Q&A with our experts.
Effects of ECHA's Advice on Dose Level Selection in DART Studies
ECHA released a report in January 2022 giving advice on dose level selection for DART (developmental and reproductive toxicology) studies. This has prompted discussion and concern across sectors, including chemical industries, around the best approach to take in designing and implementing these crucial studies while ensuring best practice in animal use and welfare. View this webinar for:
- An overview of ECHA’s advice on dose level selection
- A critical review in relation to animal use, welfare, and scientific interpretation
- Discussion around the significance for ongoing and upcoming studies
Insight Into ECHA’s Evaluation of EOGRT Study Design and Reports
ECHA released an interim report on May 9, 2022 in which they reviewed 36 Extended One Generational Reproductive Toxicity Study (EOGRTS) Reports. This has prompted questions and concerns from chemical companies around their current and future DART studies for registrations. View this webinar for discussion on:
- The critical aspects identified following ECHA’s review of 36 EOGRTS reports
- Interpretation of ECHA findings by our DART experts
- Significance for ongoing and upcoming studies
Critical Aspects to Consider for EOGRT Study Design Under REACH
In July 2021, The European Chemicals Agency (ECHA) released an analysis of 12 studies evaluated under an ongoing review project of Extended One Generational Reproductive Toxicity Studies (EOGRTS) (OECD 443). ECHA identified seven critical issues in the design and conduct of these studies.
This webinar discusses each of the critical issues and you can learn how these may impact your current and future studies.
Webinar Presenters
Still unsure about what these updates mean for your chemical program? Our regulatory experts can provide further guidance on how to navigate these updates.
ECHA’s CRO Days – Implications for your Chemical Programs
Learn our experts’ key takeaways from ECHA’s CRO Days and the possible implications for your chemical testing program.
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