ICH Project ICH E14/S7B: Q&A Briefing on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects
March 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" has been
issued as a Communication. A has been 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.