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Integrated Cardiac Safety
Session Chair(s)
Norman Stockbridge, MD, PhD
Director, Division of Cardiology and Nephrology, OND, CDER
FDA, United States
This session will discuss the evolution of cardiac safety and changes since the ICH E14 inception. Speakers will address why the TQT trial design is phasing out and discuss alternative options.
Learning Objective : Discuss the components and evolution of cardiac safety.
Speaker(s)
Risk of Drug-Induced QT Interval Prolongation by Monoclonal Antibody Medicines: A Review of Data From an EU Database
Joerg Seebeck, DrMed, MD
Merck, Germany
Integrated Cardiac Safety in the Post E14 Era
Tim Callahan, PhD
Biomedical Systems, United States
Chief Scientific Officer
Clues to Proarrhythmic Potential of Drugs From the Human ECG
David Strauss, MD, PhD
FDA, United States
Director, Division of Applied Regulatory Science, OCP, OTS, CDER
注册方法
Registration override should work.