ICCVAM Communities of Practice Webinar 2024
Implementing Computational Approaches for Regulatory Safety Assessments
Monday, January 29, 2024
Slides and video from the webinar are available below.
ICCVAM promotes the development and validation of toxicity testing methods that protect human health and the environment while replacing, reducing, or refining animal use. ICCVAM also provides guidance to test method developers and facilitates collaborations that promote the development of new test methods. This webinar, organized on behalf of ICCVAM by NICEATM, discussed implementing computational approaches for regulatory safety assessments.
Computational toxicology methods can be useful for generating bioactivity predictions for chemicals for which limited toxicity data are available. They can also help users understand and interpret large, diverse bioactivity data sets, or predict how a chemical might behave in the body. However, users with limited experience with such methods may find it difficult to use them or interpret their outputs, or even understand how the methods could be applied in a specific context.
This webinar discussed how to establish confidence in computational approaches for regulatory applications. Ongoing activities and key insights were described in three presentations by speakers from the U.S. government and the private sector focusing on applications of tools such as structure-based models to predict chemical bioactivity and pharmacokinetic models to support understanding of chemical metabolism and disposition.
Agenda
- Introductions
Helena Hogberg and Nicole Kleinstreuer, NIEHS/NICEATM - Presentations:
- EPA Perspectives on Applying the 3Rs to Ecological Risk Assessment in Support of the Registration of Pesticides
Michael Lowit, U.S. Environmental Protection Agency Office of Pesticide Programs - Assessing the Credibility of Computational Modeling and Simulation for Medical Devices
Pras Pathmanathan, U.S. Food and Drug Administration Center for Devices and Radiological Health - Calculating Bioactivity Exposure Ratios Using New Approach Methods for Chemical Assessment
Jon Arnot, Arnot Research and Consulting
- EPA Perspectives on Applying the 3Rs to Ecological Risk Assessment in Support of the Registration of Pesticides
- Q&A
Emily Reinke, Inotiv (contractor supporting NICEATM), moderator
View Federal Register notice announcing the webinar (January 17, 2024) – View notice as PDF