Dr Hiroshi Yamaguchi is Co-Chair of the APAC Council and Past Chairman of the ISPE Japan affiliate. He has also over 20 years of experience in the Medicinal and Medical device industry, held key positions at Fresenius Medical Care as Japan Quality Head, covering both commercial and manufacturing sites. At Novartis, he excelled as a QA Manager responsible for Product compliance, Audit readiness, CAPA management, DI and more.  He also gained experience in a Japanese pharmaceutical company as a CMC scientist and process engineer. He has successfully launched 8 new products in the Japanese market. Currently, he manages the CMOs in Japan as UCB Global quality team, where he strives to maintain and improve quality in line with the Japanese market. 
In his presentation, he will show the facing issues & challenges in Japan and present mainly on fostering a quality culture and developing quality leaders. It will be an opportunity to take proactive measures and think about the challenges that each country will face in the future.

 

Educational Background: 
PhD in Enterprise System, MSc in Organic Chemistry and MBA. 

His educational journey has taken him across the globe to the University of Basel in Switzerland and the National University of Singapore (NUS). In addition, he has enhanced his expertise with education course certificates of SCM from MIT.