Definitive QT Evaluation - Clinical And Operational Considerations

Navigating QT evaluation remains a critical—and often complex—part of drug development. This webinar brings together scientific, clinical, and operational perspectives to clarify how sponsors can approach definitive QT assessments in today’s regulatory environment. See how updates to ICH E14 guidance have reshaped QT strategies, including when early QT data from first-in-human or SAD trials may support a waiver versus when a full, thorough QT study is still required. Speakers break down concentration–QTc analysis, high clinical exposure scenarios, and the role of non-clinical assays, while also addressing practical considerations such as ECG collection quality, site readiness, monitoring duration, and data handling.

Get a clear view of how study design, ECG methodology, and operational execution directly impact regulatory confidence, timelines, and cost.