Kazuhiro Sase, MD, PhD is a Professor of Clinical Pharmacology and Regulatory Science at the Juntendo University in Tokyo, Japan. He has been trained as an interventional cardiologist at Kyoto University, and as a post-doctoral research fellow of Molecular Cardiology, Brigham and Women’s Hospital, Harvard Medical School in Boston, before he served as a Chief Medical Reviewer of the Pharmaceuticals and Medical Devices Evaluation Center of Ministry of Health, Labour, and Welfare in 1999, what has evolved into the Pharmaceuticals and Medical Devices Agency. In 2001, Dr. Sase was appointed Director of the Clinical Research Center, National Cardiovascular Center Hospital in Osaka. In 2005, he was appointed to his current position. He has been involved in numerous activities to support research infrastructures, including Japanese Medical Association, Center for Clinical Trials, Center for Research and Development Strategy, Japan Science and Technology Agency, Pharmaceutical Society of Japan, Health Research Initiatives, Cabinet Office, Ministry of Economy, Trade, and Industry, and Japanese Registry for Mechanically Assisted Circulatory Support. He has also been active in many international initiatives for global harmonization and regulatory convergence, including US-Japan Harmonization by Doing, Global Harmonization Task Force, Medical Device Epidemiology Network, and International Medical Devices Regulators Forum.