Complex In Vitro Model: Qualification Framework Public Workshop
The Critical Path Institute’s Predictive Safety Testing Consortium is excited to announce a public workshop to improve complex in vitro model (CIVM) development with stakeholders from the U.S. Food and Drug Administration, academia, model developers and the pharmaceutical industry.
Sept. 28-29, 2023 | The Bethesdan Hotel – Bethesda, MD
Attendees will meet to form a consensus on model standards and features that will enable the qualification of liver CIVMs for regulatory assessment. The meeting will include key opinion leaders, as well as sessions to discuss developing a Context of Use (COU), analytical considerations for establishing CIVMs and system performance, and biological performance considerations for CIVMs with appropriate test compounds and biomarker endpoints.