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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.twyfyeh676@cde.org.tw

 


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