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
|Robert Kleiman, MD
Vice President, Cardiology and Chief Medical Officer, ERT
|Borje Darpo, MD, PhD
Chief Scientific Officer, ERT