活動訊息

第七屆台日醫藥交流會議下午場候補報名

刊登日期：2019-09-23 | 點閱次數 : 760 次

主辦單位：	財團法人醫藥品查驗中心
指導單位：	衛生福利部食品藥物管理署
活動地點：	張榮發國際會議中心1101會議室(藥品場)、801會議室(醫材場)
活動日期：	108年10月1日(二)13：30~17：30

衛生福利部食品藥物管理署為推動台灣與日本醫藥合作，委託財團法人醫藥品查驗中心辦理「第七屆台日醫藥交流會議」，本會議將於2019 年10 月1 日（星期二），假張榮發基金會國際會議中心11 樓及8樓會議室(台北市中正區中山南路11 號11 樓)舉辦。議程請詳見報名資訊。
本網頁只提供下午場報名，本會議包含藥品與醫材議題，請擇一報名；會中將提供中日文口譯，需攜帶有照片的證件進行口譯設備借取，本會議不收取任何費用，本場次限100 名，為免向隅，敬請及早報名。報到事宜及口譯設備借取統一於11樓辦理。

此網頁報名恕不提供聯合場座位及午餐，請見諒。

會議議程

【Parallel session (Pharmaceutical)】 Room 1101, 11F, Chang Yung-Fa International Convention Center
13:30-14:20	ICH E17 (50 min) Moderator:Katsuaki Ura, Deputy Director, Office of International Regulatory Affairs, MHLW -Taiwan CDE's Experience to Review MRCT Results, I-Chun Lai, M.D. ,Center for Drug Evaluation (20min) -Mr. Shuji Kamada, Reviewer, Office of New Drug V, PMDA (20min) Q & A, (10min)
14:20-15:10	E-labeling schemes for medicinal products (50 min) Moderator:Ming-Mei Wu, Deputy Director, Division of Medicinal Product, TFDA -Dr. Junko Sato, Office Director, Office of International Program, PMDA (20min) -E-labeling (TBD), Mr. Po-Wen Yang, Section Chief, Division of Medicinal Products, TFDA (20min) Q & A, (10min)
15:10-15:30	Break
15:30-16:20	Update on OTC Regulation for appropriate patient access (50min) Moderator:Naoyuki Yasuda, Director, Office of International Regulatory Affairs, MHLW -Recent Progress of OTC Regulation in Japan, Dr. Hikoichiro Maegawa, Deputy Director, Pharmaceutical Evaluation Division, MHLW (20min) -Regulatory updates of OTC drugs in Taiwan, Ms. Hui-Ping Chang, Section Chief, Division of Medicinal Products, TFDA (20min) Q & A, (10min)
16:20-16:40	Break
Health Insurance
16:40-17:20	Recent trend on Health Insurance System (40 min) Moderator:Ming-Hsun Liu, Director, Division of Medicinal Product, TFDA -Drug Pricing System in Japan, Ms. Hiromi Matsuda, Deputy Director, Economic Affairs Division, Health Policy Bureau, MHLW (15min) -Drug Reimbursement Model and Challenges under Taiwan's NHI System, Ms. Hsueh-Yung (Mary) Tai, Director, Medical Review and Pharmaceutical Benefits Division, NHIA (15min) Q & A, (10min)
17:20-17:30	Closing Remarks (pharmaceuticals) -Dr. Shou-Mei Wu, Director-General, TFDA -Mr. Naoyuki Yasuda, Director, Office of International Regulatory Affairs, MHLW
【Parallel session (Medical Devices)】 Room 801, 8F, Chang Yung-Fa International Convention Center
13:30-15:20	Moderator :Dr. Chia-Hung Chien, Senior Technical Specialist, Division of Medical Devices and Cosmetics, TFDA 1.Regulations on In-Vitro Diagnostic Devices (50min) -Dr. Jui-Hsiang Lin, Senior Reviewer, Division of Medical Devices and Cosmetics, TFDA (20min) -Mr. Jiro Takei, International Policy & Strategy Committee, Asia Subcommittee, JFMDA (20min) -Q & A, (10min)) 2.Priority Review Mechanism (Sakigake Designation) for Medical Device Registration (50min) -Dr. Cheng-Wen Lan, Senior Reviewer, Division of Medical Devices and Cosmetics, TFDA (20min) -Dr. Mari Shirotani, Division Director, Office of International Programs, PMDA (20min) -Q & A, (10min) 3.Closing Remarks(10min) -Ms. Pei-Weng Tu, Director, Division of Medical Devices and Cosmetics, TFDA -Dr. Mari Shirotani, Division Director, Office of International Programs, PMDA
15:20-15:40	Break
15:40-17:30	WG Closed meeting (Reg. + Industry) -Product registration WG -QMS WG

報名資訊

報名方式	採網路報名。為維護課程品質，恕不接受現場報名。
報名人數	下午場次限額100人，本中心保留接受報名與否的權利。
報名費用	需攜帶有照片的證件進行口譯設備借取。
與會須知	會議進行期間未獲許可，請勿錄音錄影。
聯絡窗口	姓名：張專員或葉企劃經理電話：02-8170-6000 分機 631 或 613 信箱：ccchang469@cde.org.tw 或 yfyeh676@cde.org.tw

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