Yasuhiro HASEGAWA Development Regulatory Affairs Mitsubishi Tanabe Pharma Corp / Kazuyo MARUCHI Product Development Regulatory Affairs Shionogi & Co Ltd / Medical Personnel / Regulatory Affairs Global Regulatory Affairs CFU Eisai Co Ltd / YONEDA New Drug Regulatory Affairs Daiichi Sankyo Co Ltd / Approval And Licenses Drug Manufacturing / Sanofi / Quality Assurance Kyowa Hakko Kirin Co Ltd / Quality & Regulatory Compliance Chugai Pharmaceutical Co Ltd / Toshio SATO Regulatory Affairs Otsuka Pharmaceutical Co Ltd / /
Country
Japan / / /
Event
Product Issues / Product Recall / FDA Phase / /
Facility
ICH pyramid / National Institute of Biomedical Innovation / National Institute of Infectious Diseases / Harmonization National Institute of Health Sciences / JAPAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION Torii-Nihonbashi Bldg. / / /
Blood and Blood Products Division / Institute of Health Sciences / office of Vaccines / office of Chemical Safety / National Institute of Health / office of Review Management / AIDS Research Center / office of Vaccines and Blood Products / Economic Affairs Division / World Health Organization / ENGLISH REGULATORY INFORMATION TASK FORCE INTERNATIONAL AFFAIRS COMMITTEE / National Institute of Biomedical Innovation / Research and Development Division / Health Policy Bureau / Pharmaceutical Affairs and Food Sanitation Reevaluation Council / office of Safety / office of Direction / office of International Programs / Safety Division / office of Review Administration / Manufacturing/Marketing Approvals office of Medical Devices Evaluation / Japan Health Sciences Foundation / office of Compliance and Standards / GMP GPMSP / Medical Devices Agency Office / Blood Products / English Regulatory Information Task Force / Evaluation and Licensing Division / Labeling and Package Inserts office of Cellular and Tissue-based Products / Ministry of Health / Compliance and Narcotics Division / Licensing Division / Institute of Infectious Diseases / office of Standards / office of Drug Induced Damages / Pharmaceutical and Food Safety Bureau / /
Person
Kazuhiro SASAKI / / /
Position
Government Batch Test General Affairs / Leader / GCP Good Post-marketing Surveillance Practice General / General / /
Product
Sanofi KK / Honcho / Product / Concerning Drug / NEW DRUGS / /
Index Special Licensing System Before ApprovalTransfer of Approvals ..................................... 49