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[Session 3] Early Phase Clinical Strategies for Assessing Drug-induced Pro-arrhythmia Risk
Session Chair(s)
Hiroyuki Fukase, MD, PhD
Director, Clinical Research Center
Clinical Research Hospital Tokyo, Japan
Boaz Mendzelevski, MD
Consultant Cardiologist
Cardiac Safety Consultants Ltd., United Kingdom
Speaker(s)
Bridging/Translating Non-clinical and Early Clinical QT Studies
Atsushi Sugiyama, MD, PhD
Toho University Faculty of Medicine, Japan
Professor and Chairman, Department of Pharmacology
Advanced Approach to Assessment of QT and Proarrhythmic Potential in Monkey toward the Early Clinical QT Assessment
Ryuichi Komatsu
Chugai Pharmaceutical Co., Ltd., Japan
Safety Assessment Department
Early Development Strategies to Replace the TQT Study
Börje C. Darpö, MD, PhD
Clario, Sweden
Chief Scientific Officer, Cardiac Safety
Implementation of CR Modeling in Ph I Studies to Evaluate QTc Prolongation Risk in Japan
Kinue Nishioka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of Advanced Evaluation with Electronic Data
Intensive QT Evaluation in Phase 1 vs. TQT Study – Industry View Points
Sanae Yasuda, PhD
Japan
Senior Director, Clinical Pharmacology, Medicine Development Center
Can Moxifloxacin be Replaced by a Meal?
Jorg Taubel, MD, FFPM
Richmond Pharmacology, United Kingdom
Chief Executive Officer
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