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# Webinar on Drug QT/Proarrhythmic Risk Assessments
- URL: https://www.fdaweb.com/webinar-on-drug-qt-proarrhythmic-risk-assessments/
- Published: 2020-09-24T12:00:00.000Z
- Updated: 2026-09-14T16:30:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147726

FDA has announced a two-day (10/15-16) public Webinar on “[New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDA5MjIuMjc1NjAxNzEiLCJ1cmwiOiJodHRwczovL2dvLnVzYS5nb3YveEdFY3g%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.DypZdwwMSRd34nRy5nks%5FHF3AV5HM6JaTOettQExcsU/s/1255931999/br/85788264312-l?ref=fdaweb.com).” The Webinar supports a new [Questions & Answers to ICH E14 and S7B](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDA5MjIuMjc1NjAxNzEiLCJ1cmwiOiJodHRwczovL2RhdGFiYXNlLmljaC5vcmcvc2l0ZXMvZGVmYXVsdC9maWxlcy9JQ0hfRTE0LVM3Ql9RQXNfU3RlcDJfMjAyMF8wODI3XzAucGRmP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.DNyDBqvVLyOheGMccqWtteZepdAAWkzQ19%5FU6DJBxw4/s/1255931999/br/85788264312-l?ref=fdaweb.com) guidance, which were [recently released](https://www.ich.org/news/ich-e14s7b-draft-qas-available-now-ich-website?ref=fdaweb.com) 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](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDA5MjIuMjc1NjAxNzEiLCJ1cmwiOiJodHRwczovL2dvLnVzYS5nb3YveEdFY3g%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.DypZdwwMSRd34nRy5nks%5FHF3AV5HM6JaTOettQExcsU/s/1255931999/br/85788264312-l?ref=fdaweb.com) 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.