As stated in the recently published paper by the IWG (Vargas HM et al, 2020) “The time has come to meaningfully merge nonclinical and clinical data to enable a more comprehensive, but flexible, clinical risk assessment strategy for QTc monitoring”.
As a safety pharmacology leader, your voice matters! the ICH E14/S7B Q&As are still open for comment in some regions, but not for much longer! Stakeholders from ICH Member countries/regions are encouraged to submit their comments to their respective Regulatory Authorities prior to their deadlines.
This free two-day public webinar hosted by FDA will be presented by multiple regulatory and industry members from around the world that are members of the International Council for Harmonisation (ICH) E14/S7B Implementation Working Group
Read the latest update from the CiPA Steering Team, released this month
In order to ascertain how the guidance is used and the relevance of individual studies to current drug development portfolios, the Safety Pharmacology Society and NC3Rs have generated a short survey to gather high-level information on the opinions of individual scientists into the scope for revis...