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Dr. Tetsuya Kusakabe


He is working for manufacturing quality, post-marketing safety, and international regulatory harmonization of medical devices at PMDA.

He has been working at the Ministry of Health, Labour and Welfare (MHLW) since 1996, and mainly involved in pharmaceutical administration. During this time, he was involved in research promotion of medical products at the Ministry of Education, Culture, Sports, Science and Technology (MEXT) from July 2000 to August 2002. He was a Visiting Scientist at U.S. Pharmacopeia (USP) working as a liaison between US and Japan from July 2011 to August 2012. He was a Review Director at PMDA, and engaged in reviewing bio-pharmaceuticals including cellular and tissue-based products, and gene therapies from August 2012 to December 2013. He was a Professor at Osaka City University, Graduate School of Medicine, and was working for promoting clinical trials and medical innovation from July 2017 to July 2020.