Dr. Tatsuo Kurokawa started his career as a staff of Japan’s Ministry of Health, Labour and Welfare (MHLW). It includes NDA review, safety measures, ICH and international collaboration. After 35 years of service, he became prof. of Keio University, Facuty of Pharmacy,Regulatory Sciences.
I was born at Yokohama-city and met Mr.Kurokawa at the Univercity in same class.When my daughter got in serious,I really noticed the contradicted medelical systems.So, I have thought about gaps of governer'thinking and ordinary people'desires.
Kazuhiko Mori, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Kazuhiko Mori, MS, is currently the Associate Director of Center for Product Evaluation in Pharmaceuticals and Medical devices Agency (PMDA). He is responsible for the coordination of the review and evaluation of NDA, scientific advice and consultation to pharmaceutical industry for clinical develop
Pharmacist. Started the carrier as researcher of pharmacology microbiology. Since 1991, changed it to gain further experience as regulatory scientist in the global pharmaceutical companies (Upjohn, Roche, Eli Lilly). Mid of 2007, joined Banyu as director of Reg. and vaccine policy group.
Description
Patients and lay people in Japan now form one of the major groups that support current drug development, safety, supply, and regulatory affairs. This session will discuss recent change and the significant effect of the patient voice on drug policy and the progress of the amendment of the Pharmaceutical Affairs Law.
Learning Objectives: Recognize recent change and the significant effect of the patient voice on drug policy and the legal amendment Discuss some inconsistency and even slight tensions among safety oriented groups and drug lag oriented groups Discuss the future direction of the amendment of Pharmaceutical Affairs Law.