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Haruhiro Okuda |

Director General | Japan NIHS

Dr. Haruhiro Okuda is a pharmacist and the Deputy Director-General of National Institute of Health Sciences (NIHS), the Ministry of Health, Labor, and Welfare (MHLW). He graduated from the University of Tokyo, Faculty of Pharmaceutical Sciences and received Ph.D degree in medicinal chemistry from graduate school of Pharmaceutical Sciences, University of Tokyo.

From 1984 to 1998, he studied drug metabolism and molecular toxicology as a researcher, associated researcher, and associated professor of Tokyo University of Pharmacy and Life Science, School of Pharmacy. From 1998 to 2002, he joined the Pharmaceuticals and Medical Devices Evaluation Center, the predecessor of PMDA, and was engaged in review of new drug approval application as a reviewer and an evaluation manager.

Since 2002, he has worked for NIHS, and served as Head of Division of Organic Chemistry and Head of Division of Drugs. He was then promoted to the present position in 2013. After he was transferred to NIHS, he continued to be involved in evaluation of a quality aspect of chemical drugs submitted for registration to MHLW as well as revision of monographs on chemical drugs listed in the Japanese Pharmacopoeia (JP). He is also engaged in nomenclature of pharmaceuticals as the chair of JAN committee.

He is a member of the Pharmaceutical Affairs and Food and Sanitation Council in Japan. He worked to harmonize regulation on quality of chemical drugs for over 10 years as a member of ICH Q6 Implementation Working Group, ICH Q8 Expert Working Group and ICH Q11 Expert Working Group. He is now a member of ICH Q11 Implementation Working Group. He also works to harmonize Pharmacopoeias of Japan, EU, and the USA and attends PDG (Pharmacopoeia Discussion Group) meeting as the chair of committee on International Harmonization for the revision of JP. He has acted as a temporary adviser of INN since 2005.

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