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Nihonbashi Life Science HUB

2018 年 10 月 25 日 9:00 上午 - 2018 年 10 月 26 日 6:00 下午

8F, 1-5-5 Nihonbashi-muromachi, Chuo-ku, Tokyo, 103-0022 Japan

7th DIA Cardiac Safety Workshop in Japan

It will be a unique opportunity to learn of and discuss the current state and future directions of CV risk assessments and how to prepare for a new regulatory paradigm.

[Session 1] Clinical Proarrhythmic Risk Assessment

Session Chair(s)

Boaz  Mendzelevski, MD

Boaz Mendzelevski, MD

Consultant Cardiologist

Cardiac Safety Consultants Ltd., United Kingdom

Kaori  Shinagawa, MD, PhD

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

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

Jose  Vicente, PhD

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

Krishna  Prasad, DrMed, MD, MRCP, FRCP

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

Börje C. Darpö, MD, PhD

Experience from QT Assessment Using Concentration-QTc Modeling of Early Phase Studies

Börje C. Darpö, MD, PhD

Clario, Sweden

Chief Scientific Officer, Cardiac Safety

Atsushi  Sugiyama, MD, PhD

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

Jorg  Taubel, MD, FFPM

Experience with CR Modelling across Different Types of Early Phase Clinical Trials

Jorg Taubel, MD, FFPM

Richmond Pharmacology, United Kingdom

Chief Executive Officer

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