Autoren

National Institute of Health Sciences, the Ministry of Health, Labour and Welfare, Japan.

Yukio Hiyama received Ph.D. degree in 1979 in Chemistry from University of Tokyo. His current position is Chief, Third Section, Division of Drugs, NIHS, MHLW.

Responsibilities include research on pharmaceutical quality control and training of GMP inspectors. He leads an industry-government Human Science project on analytical method development for pharmaceutical development. He also leads MHLW's study groups to draft GMP related guidances and to propose the regulatory framework under the revised Pharmaceutical Affairs Law. He is a member of Pharmaceutical, Food and Sanitation Council and a co-chair of JP Chemical Monograph Committee. He has been involved in the ICH for Q8, Q9 and Q10. He is currently Q-IWG member for MHLW. His previous work experiences include scientist and director positions in Pharmaceutical Development in Upjohn Co. in US and in Japan, Visiting Associate: National Institutes of Health, Bethesda MD USA and Post-doctoral research associate: Department of Chemistry, University Illinois, Urbana IL USA.