ICH Project Q&A Workshop on ICH E14/S7B "Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential"
March 17, 2023
Based on the review by the ICH E14/S7B Implementation Working Group (IWG), the Q&A on the E14/S7B Guideline has reached Step 5 and the Q&A on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects" is issued as an administrative communication The Q&As are issued as an Administrative Communication. The purpose of this briefing session was to promote understanding of these Q&As.
The details of this briefing session, including the program, can be found on the PMDA Website.