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Hirofumi Suzuki has a PhD in pharmaceutical sciences from Okayama University and MBA from NUCB. He has been Senior Regulatory CMC Adviser since February 01, 2019 of Bayer Yakuhin Ltd. Japan. He served as Head of CMC of Bayer Yakuhin from 2007 until 2019. In this position he managed Regulatory activities, Pharmaceutical Development, Investigational Products Supply and Quality Assurance. He served as Head of CMC Development Department of Nihon Schering K.K. Japan from 2004 until 2007. Prior to Schering, he held multiple positions in CMC area at Nihon Organon and Kanebo Japan. While at Kanebo, he worked at Northeastern University from 1995 till 1996 as Visiting Scientist. During more than 30 years of experience in CMC development, manufacturing and quality, he served as Head of EFPIA Japan Quality Group from 2014 to 2016 and Head of Pharmaceutical Experts Group of Japan Pharmaceutical Manufacturers Association from 2016 to 2018. After joining ISPE in 2008, he became Japan IP-COP leader, Director of ISPE Japan from 2010 to 2017 and Chair of ISPE Japan from 2017 to 2019.