Uncovering the Regulatory Advice Affecting OECD 443 Study Design and the Impact on Your Ongoing and Future Studies, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speakers will give a summary of recent regulatory advice (July 2021) concerning the Extended One-Generation Reproductive Toxicity Study (OECD 443) and address the context of the advice. Attendees will learn about the impact of regulatory criticisms and advice on the design of ongoing studies, future studies, time and cost.

These recommendations have resulted in the necessity to amend the design of ongoing and planned studies ultimately affecting resources, time and cost of a study which was already complex and costly.

The Extended One Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, Annexes IX and X, Section 8.7.3.) since March 2015. In July 2021, an evaluation of Organisation for Economic Cooperation and Development (OECD) 443 studies led by the European Chemicals Agency (ECHA) revealed critical issues with study designs that had the potential to compromise data analysis and interpretation.

Resulting regulatory advice had an immediate impact upon the design of ongoing and planned OECD 443 studies. Recommendations emphasized demonstrating the highest possible dose level showing reproductive effects without severe suffering or deaths in P0 animals and provided clarity on expectations for histopathology of Cohort 1B animals and intermediate and low dose level groups.

This webinar will discuss a retrospective analysis of studies conducted at Labcorp comparing anonymized sexual maturation data to assess the relative merits of increasing the number of animals evaluated. These recommendations have resulted in the necessity to amend the design of ongoing and planned studies ultimately affecting resources, time and cost of a study which was already complex and costly.

Join expert speakers from Labcorp, Steven Renaut, Associate Director, Development and Reproductive Toxicology (DART); and Julie Passage, Study Director, Safety Assessment, Crop Protection and Chemicals, in a live webinar on Friday, November 19, 2021 at 10am EST (3pm GMT/UK) to learn about the relative merits and consequences of these recommendations from a practical perspective.

For more information, or to register for this event, visit Uncovering the Regulatory Advice Affecting OECD 443 Study Design and the Impact on Your Ongoing and Future Studies.

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Sydney Perelmutter
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