REPLAY: ERT Briefing: ICH E14 and S7B Questions and Answers


Join us for a replay of: ERT Briefing: ICH E14 and S7B Questions and Answers on Dec 16th, 17:00 JST.

Robert Kleiman, MD and Borje Darpo, MD, Ph.D. will conduct a briefing on the FDA’s latest two-day presentation and discussion on the draft Q&As to ICH E14 and S7B from the International Council for Harmonisation (ICH) E14/S7B Implementation Working Group, with live translation for our Japanese-speaking audience. This meeting covered revised questions and answers for the ICH guidance,  new Q&As for the ICH guidance for the industry, providing recommendations on considerations for an integrated risk assessment combining nonclinical and clinical data. 

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

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.