Join us for an ERT Briefing: ICH E14 and S7B Questions and Answers on February 23rd at 11:30 am IST, 2 pm CST, 5 pm AEDT.


ERT’s expert cardiologists, 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.


Featured topics include: 

  • Background for the new Q&As for ICH E14 and S7B

  • High-level summary of proposed key changes in non-clinical assays

  • How clinical assessments may be affected when sufficiently high doses cannot be safely given or cannot be obtained

  • How the revised guidance may impact the interpretation of clinical studies performed without a positive control

  • Live audience Q&A with Dr. Darpo


Panelists
 

Robert Kleiman, MD
Vice President, Cardiology and Chief Medical Officer, ERT

 
Borje Darpo, MD, PhD
Chief Scientific Officer, ERT