ERT Briefing: ICH E14 and S7B Questions and Answers


The International Council for Harmonisation (ICH) E14/S7B Implementation Working Group recently held a two-day presentation and discussion which covered the revised questions and answers for the ICH guidance for 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 S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals, providing recommendations on considerations for an integrated risk assessment combining nonclinical and clinical data. 

ERT’s cardiologists Dr Kleiman and Dr. Darpo will share their views on how the revised guidance may impact how sponsors perform ECG and QT evaluation in clinical trials, with emphasis on requirements on exposure-response analysis to exclude that a drug has a clinically relevant effect on the QTc interval. 

Featured topics include: 

  • Background for the new Q&As for ICH E14 and S7B
  • Summary of key changes in non-clinical assays
  • How clinical assessments are being affected
  • Audience Q&A

Register now to join us there. 

FEATURED GUEST


Borje Darpo


DR. BORJE DARPO

Chief Scientific Officer of Cardiac Safety
ERT

As ERT’s Chief Scientific Officer, Borje Darpo, MD, PhD oversees ERT’s cardiology services and consults with external customers to ensure the cardiac safety of their compounds in development. He is board certified in cardiology and internal medicine and has 20 years of experience overseeing projects across all phases of clinical development.

 

 

 

 

 

 

 

DR. ROBERT KLEIMAN

Chief Medical Officer.
ERT

Dr. Robert Kleiman is a board-certified cardiologist and cardiac electrophysiologist who has performed research in both basic cellular electrophysiology as well as clinical electrophysiology. Dr. Kleiman is currently ERT’s Chief Medical Officer and Vice President, Global Cardiology. His responsibilities include oversight of ERT’s cardiology services, consulting with external clients and managing overall satisfaction of ERT’s global customers, including all aspects of ERT’s solutions.