Webinar on Drug QT/Proarrhythmic Risk Assessments

FDA has announced a two-day (10/15-16) public Webinar on “New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment.” The Webinar supports a new Questions & Answers to ICH E14 and S7B guidance, which were recently released by ICH as a draft guideline for public consultation. It will provide an overview of the new Q&As, followed by presentations on each of the main Q&A topics. Example cases will be presented that discuss the potential impact of applying the principles in the new Q&As on drug development and regulatory evaluation.

The new Q&As “describe how nonclinical assays can be used as a part of an integrated risk assessment prior to first-in-human studies as they are used today, and in later stages of clinical development as a part of a combined nonclinical-clinical integrated risk assessment,” an FDA notice says. If implemented, they can lead to a reduction in the number of “thorough QT” clinical studies and improved decision-making at the time of a marketing application.