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Session 1-1: Integrated Cardiac Safety - Regulatory Update
Session Chair(s)
Krishna Prasad, DrMed, MD, MRCP, FRCP
Deputy Director, Innovative Medicines, HQA/Licensing
Medicines and Healthcare Products Regulatory Agency (MHRA), 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)
Comprehensive in vitro Proarrhythmia Assay
Norman Stockbridge, MD, PhD
FDA, United States
Director, Division of Cardiology and Nephrology, OND, CDER
Current Status and Future Perspectives on ICH S7B including CiPA (tentative)
John E. Koerner, PhD
FDA, United States
Sr. Pharmacologist, OND, CDER
The IQ-CSRC Prospective Clinical Study: Can 'Early QT Assessment' Replace the TQT Study?
Börje C. Darpö, MD, PhD
Clario, Sweden
Chief Scientific Officer, Cardiac Safety
Current Status and Future Perspectives on ICH E14 (tentative)
Kana Watanabe
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug V
Alternatives to TQT - Early Clinical QT or Proarrhythmia? Do we know?
Krishna Prasad, DrMed, MD, MRCP, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director, Innovative Medicines, HQA/Licensing
Exploring Alternative Cardiac Safety Paradigms: A Regulatory Perspective
Colette Strnadova, PhD
Health Canada, Canada
Senior Scientific Advisor, Therapeutic Products Directorate
Panel Discussion
All Session Speakers, United States
Koki Nakamura, MD, PhD
Takeda Pharmaceutical Company Limited, Japan
Vice President, CVM Marketing, Japan Pharma Business Unit
Atsushi Sugiyama, MD, PhD
Toho University Faculty of Medicine, Japan
Professor and Chairman, Department of Pharmacology
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