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FDA News: Issue 30, September 2020

Author: [AUTHOR] Published on 9/25/2020 8:06:00 AM


FDA Announces ICH E14/S7B Webinar: New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment

The Food and Drug Administration (FDA) will host a free, two-day public webinar on October 15-16, 2020 titled "New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment." Multiple regulatory and industry members from around the world that are members of the International Council for Harmonisation (ICH) E14/S7B Implementation Working Group will present on the Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential.

The ICH E14/S7B Implementation Working Group developed new Questions & Answers (Q&As) to ICH E14 and S7B, which were released by ICH as a Draft Guideline for public consultation on August 27, 2020.

The webinar will cover the background, motivation for, and overview of the new Q&As for ICH E14/S7B, followed by presentations on each of the main Q&A topics. 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. 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.

Example cases will be presented that highlight the potential impact of applying the principles in the new Q&As on drug development and regulatory evaluation. Questions can be submitted via the Q&A pod during the webinar and will be discussed at the end of each of the two sessions by members of the E14/S7B working group.

This webinar is intended for the following audience:
  • Nonclinical and clinical scientists involved in the performance, assessment, or evaluation of studies under ICH E14 and S7B from regulators, pharmaceutical industry, contract research organizations and instrument providers, as well as pharmaceutical/regulatory consultants with expertise in this area
  • Researchers or clinicians with an interest in assessment of proarrhythmia
  • Drug development professionals and stakeholders with an interest in understanding the potential impact of the draft Q&As
Dates/Times of the Webinar:
  • Tuesday, October 15, 2020 - 8:00-10:30 am US EDT (UTC/GMT -4 hours)
  • Wednesday, October 16, 2020 - 8:00-10:30 am US EDT (UTC/GMT -4 hours)
Additional details about this webinar, including registration, agenda, and supplementary resources such as the original E14/S7B Guidelines (May 2005), Work Plan (April 2020), and Concept Paper (2018), are available at https://go.usa.gov/xGEcx.


The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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