第2回 日本-タイ合同シンポジウム

MC：Dr. Nantana Kaisaeng
　　　(Office of International Affairs, ThaiFDA)

　(1) Dr. Kazuhiro Shigetoh
　　　　(Executive Director, PMDA)

　(2) Mr. Akihiko Uchikawa
　　　　(Minister of Economics, Embassy of Japan in Thailand)

　(3) Dr. Boonchai Somboonsook
　　　　(Secretary-General, ThaiFDA)

Chair： 1) Dr. Yuppadee Javroongrit
　　　　　　 (Senior Expert on Pharmaceuticals Standard, ThaiFDA)
　　　　   2) Mr. Kaoru Misawa
　　　　　　 (International Coordination Officer for Pharmaceuticals, PMDA)

(1) New Drug Review System of ThaiFDA (60')

Dr. Tharnkamol Chanprapaph
(Bureau of Drug Control, ThaiFDA)

(2) Recent Update of Medical Product Regulation in Japan (60')

Mr. Kaoru Misawa
(International Coordination Officer for Pharmaceuticals, PMDA)

(3) New Drug Application (NDA) Review of Anticancer Drugs in Japan (60')

Dr. Takahiro Nonaka
(Review Director, Office of New Drug V, PMDA)

Discussion

Chair： 1) Mr. Vinit Usavakidviree
　　　　　　 (Senior Advisor in Safety, Effectiveness and Advisory in Safety and Efficacy of Health Products, ThaiFDA)
　　　　  2) Mr. Daisuke Koga
　　　　　　 (Deputy Director for Medical Devices, Office of International Programs, PMDA)

(1) ThaiFDA and PIC/S Membership (60’)
　　Ms. Thitiporn Tanratanawongs
　　(Bureau of Drug Control, ThaiFDA)

Coffee Break (15')

(2) Participation in PICS (60')
　　Mr. Ichiro Tsunoi
　　(Director, Office of Manufacturing/Quality Compliance, PMDA)

Discussion (15')

Chair： 1) Ms. Sukanya Jiarapong
　　　　　　 (Senior Expert in Safety and Efficacy of Drugs and Drugs Usages, ThaiFDA)
　　　　 2) Mr. Daisuke Koga
　　　　　　 (Deputy Director for Medical Devices, Office of International Programs, PMDA)

(1) Data Management and Utilization of Pharmacovigilance (90’)
　　1. Ms. Wimon Suwankesawong
　　　 (Head of Health Product Vigilance Center, ThaiFDA)
　　2. Ms. Sareeya Wechwithan
　　　 (Health Product Vigilance Center, ThaiFDA)

Coffee Break (15')

(2) Present and Future of Drug Safety Measures in Japan (45')
　　Ms. Kaori Yamada
　　(Division of Epidemiology, Office of Safety I, PMDA)

Discussion (30’)

(1) Dr. Pathom Sawanpanyalert
　　(Deputy Secretary-General, ThaiFDA)

(2) Dr. Mayumi Shikano
　　(Associate Center Director for Advanced Review with Electronic Data Promotion and Science Board, PMDA)