Koichi Miyazaki is currently Asia region head of regulatory affairs. In this capacity, he is responsible for wide range of regulatory affairs issues including IND, NDA, and post-NDA approval requirements in Asia excluding Japan.
Prior to taking current position, he was project leader responsible for Asian countries in mega-global studies and his responsibilities include developing, implementing, and maintaining a global operational strategy that supports all clinical trial activities, and also management of subsidiary offices in Asia.
Before taking project leader position, he spent years in US as project manager with overall responsibilities for study operational aspects of clinical trials both in US local studies and global studies in cardiovascular field. He also served as liaison between East and West to harmonize differences in culture and practice to establish standardized procedures applicable for all studies. His areas of interest include cross-cultural communication and optimization of broad range of differences among regions.