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[Session 1] Clinical Proarrhythmic Risk Assessment
Session Chair(s)
Boaz Mendzelevski, MD
Consultant Cardiologist, Cardiac Safety Consultants Ltd., United Kingdom
Kaori Shinagawa, MD, PHD
Senior Scientist for Clinical Medicine, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Kaori Shinagawa, MD, PHD
Senior Scientist for Clinical Medicine, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulatory Perspective for Clinical Proarrhythmic Risk Assessment
Jose Vicente, PHD
Staff Fellow, Div of Cardiovascular & Renal Products,Office of Drug Evaluation I, U.S. Food and Drug Administration (FDA), United States
Differentiating Drug-Induced ion Channel Effects on the ECG: Potential Role of the ECG under CiPA
Krishna Prasad, DrMed, MD, MRCP, FRCP
Deputy Director, Innovative Medicines, HQA/Licensing, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Regulatory Perspective for CR Modeling in Early Phase Studies and Other Biomarkers for Clinical Proarrhythmic Risk Assessment
Börje C. Darpö, MD, PHD
Chief Scientific Officer, Cardiac Safety, Clario, Sweden
Experience from QT Assessment Using Concentration-QTc Modeling of Early Phase Studies
Atsushi Sugiyama, MD, PHD
Professor and Chairman, Department of Pharmacology, Toho University Faculty of Medicine, Japan
Effects of Moxifloxacin on the Proarrhythmic Surrogate Markers in Healthy Subjects: Exposure-Response Modeling using ECG Data of Thorough QT/QTc Study
Jorg Taubel, MD, FFPM
Chief Executive Officer, Richmond Pharmacology, United Kingdom
Experience with CR Modelling across Different Types of Early Phase Clinical Trials
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