z_Do Not Use - Closed: Systems Pharmacology Community

The Food and Drug Administration (FDA or Agency) announced the availability of a draft guidance for industry entitled “E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential—Questions and Answers” in 2020. The draft guidance contains revised questions and answers (Q&As) for the ICH guidance for industry “E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs” and new Q&As for the ICH guidance for industry “S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals”. E14 and S7B guidance provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development as per the regulatory requirements.

We have a panel of nonclinical and clinical experts that will answer any questions you may have regarding QT/QTc evaluations.

Learning Objectives:
1) Understand the updated E14 and S7B guidance and their application
2) Understand QT/QTc evaluation strategy for different molecules

Register: https://www.pathlms.com/aaps/webinars/20019

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Nimita Dave
Associate Director, Quantitative Pharmacology
Blueprint Medicines
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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