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[Session 1] Regulatory Sciences
Session Chair(s)
Yuji Kumagai, MD, PhD
Professor, Kitasato Clinical Research Center
Kitasato University Hospital, Japan
Kaori Shinagawa, MD, PhD
Senior Scientist for Clinical Medicine, Office of New Drug II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Current Status and Future Perspective of Cardiovascular Safety Assessment from a Japanese Regulatory View Point
Kaori Shinagawa, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist for Clinical Medicine, Office of New Drug II
Regulatory Science: An FDA Perspective
Naomi Lowy, MD
FDA , United States
Associate Director for Regulatory Science, Office of Drug Evaluation I
Cardiovascular Safety - EU Perspective
Krishna Prasad, DrMed, MD, MRCP, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director, Innovative Medicines, HQA/Licensing
Health Canada Update
Colette Strnadova, PhD
Health Canada, Canada
Senior Scientific Advisor, Therapeutic Products Directorate
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