ICH Project ICH E14/S7B: Q&A Briefing on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects
Mar 17, 2023
Based on the discussion in 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" was issued as an administrative communication. The Q&As are issued as an Administrative Communication. The purpose of the meeting was to provide an understanding of these Q&As.
The program and other details of the briefing can be found on the PMDA Website.
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