Complex In Vitro Model: Qualification Framework Public Workshop

Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) is delighted to announce the second public workshop on evidentiary considerations for regulatory assessment and qualification of complex in vitro models (CIVMs). Building upon outputs from the first workshop held in September 2023, attendees will comprise individuals from health authorities, academia, model developers, and the pharmaceutical industry. The workshop will provide a platform for attendees to discuss and deliberate on the evidentiary considerations for regulatory assessment and qualification of complex in vitro models. Attendees will work towards achieving a consensus on the model standards and features to improve the performance of CIVMs as a tool for drug development and regulatory assessment.

The meeting will include sessions from key opinion leaders on general considerations for qualification, as well as interactive breakout sessions focusing on specifics related to different organ systems and disease models. The breakout participants will have the opportunity to engage in discussions and deliberations on the evidentiary considerations for regulatory assessment and qualification of complex in vitro models.

The public workshop will be held September 26 and 27, 2024 in Bethesda, Maryland at The Bethesdan Hotel (8120 Wisconsin Ave, Bethesda, MD 20814).

If you are unable to attend in person and would like to participate virtually, please contact Laura Lummus (llummus@c-path.org).