Bio: Ms. Ulrey is the President of the Institute for In Vitro Sciences (IIVS) and a member of its Board of Directors. As President, Amanda is responsible for planning, directing, and coordinating activities to achieve IIVS’ mission of increasing the use and acceptance of in vitro methods. She has developed and launched IIVS’ business-to-business certification in Good In Vitro Method Practices (GIVIMP). She has been a Registered Quality Assurance Professional in Good Laboratory Practices (GLP) since 2005 and currently serves as an elected member of the Society of Quality Assurance (SQA) Board of Directors.

Abstract: The demand for toxicology data from human-relevant New Approach Methodologies (NAMs) continues to increase. Fortunately, the scientific community has responded with new tools based on human tissues and cells. The creators of these systems and test methods invest in their development and in validations designed to demonstrate their relevance, reproducibility, and transferability. To bridge the gap between method development and regulatory acceptance, industry best quality practices need to be embraced by all stakeholders as early as possible in development and maintained throughout the life cycle of a test method. The Good In Vitro Method Practices (GIVIMP) guidance document was published by the OECD in 2018 with the aim to “improve the reliability and robustness of in vitro methods, reducing the uncertainties of in vitro-based predictions and therefore increasing the acceptance of the in vitro-estimated safety measures by regulatory agencies” (OECD, 2018). The breadth of information presented in GIVIMP has posed challenges for its uptake and use by the in vitro testing community. This presentation provides an overview of the GIVIMP guidance, including points to consider for anyone implementing it within their laboratories as a step toward improving scientific confidence in NAMs.