E. Stewart Geary, M.D, has worked at Eisai since 1996 in pharmacovigilance, clinical safety and regulatory science. He is currently a member of the CIOMS IX Working Group on Risk Management, the Executive Committees of JAPhMed and the CEPM.
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.
Yorozu Tabata, PRTM, Japan
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
Description
This symposium will provide an update on the latest developments in pharmacovigilance in Japan with speakers from the regulatory authority and the pharmaceutical industry based in Japan. Discussions will provide both an overall description of the current system of drug safety regulation, as well as recently implemented changes and the prospects for further developments in drug safety regulation in Japan.
Learning Objectives: Identify the latest developments in pharmacovigilance in Japan Describe the status of Risk Management Plans and the DSUR in Japan Recognize your ability to anticipate the Pharmacovigilance needs of your partners in Japan.