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