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Regulatory Perspective-Presentation
Citation:
Makris, S. Regulatory Perspective-Presentation. Future Tox IV, Arlington, Virginia, November 14 - 16, 2018.
Impact/Purpose:
This is an introductory presentation for a breakout session at the Future Tox IV meeting/workshop. The presentation discusses how assessment of developmental/reproductive toxicity?can be influenced by many factors.
Description:
This presentation is intended to introduce a diverse audience to the complexity of the historical testing paradigm for developmental and reproductive toxicity testing and risk evaluation. Alternative methodological testing frameworks will need to be flexible and integrated in order to address the information requirements for various agencies and regulations. There is already significant movement towards incorporating mechanistic and ontological data into regulatory decision-making. The use of mechanistic data and a putative AOP in a WOE evaluation for effects of TCE on fetal cardiac development is shown as an example.