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活動訊息

第八屆台日醫藥交流會議
8th Joint Conference of Taiwan and Japan on Medical Products Regulation

刊登日期:2020-09-18  |  點閱次數 : 2780 次 
主辦單位: 公益財団法人日本台湾交流協会(Japan-Taiwan Exchange Association)
台灣日本關係協會(Taiwan-Japan Relations Association)
協辦單位: 独立行政法人医薬品医療機器総合機構(Pharmaceuticals and Medical Devices Agency))
衛生福利部食品薬物管理署(Taiwan Food and Drug Administration)
財團法人醫藥品查驗中心(Center for Drug Evaluation)
活動地點: 生技園區C棟 C201 (台北市南港區研究院路一段130巷99號 (代表號)
活動日期: 109年10月15日(四)11:00~16:00

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「第八屆台日醫藥交流會議」,訂於2020 年10 月15日(星期四),假國家生技園區C棟 C201會議廳 (台北市南港區研究院路一段130巷99號舉辦),議程如下,本屆會議由日方主辦,配合時差緣故,將於台灣時間當天上午11:00開始報到。
因應COVID-19疫情,台灣與會者將於C201會議廳以視訊方式與日方代表交流。會場僅提供中文語音,分別為中文演講及日方演講之中文即時口譯。本會議不收取任何費用,本場次限額300 名,為免向隅,敬請及早報名。為配合防疫措施,參加者請先測量體溫,額溫高於攝氏37.5度,請在家休養。參加者請自備口罩並全程配戴。

會議議程
【Joint Session】
MC:FUKUDA Eriko, International Cooperation Officer, PMDA
11:00-11:50 Registration
11:50-12:00 Photo Session
12:00-12:10 Opening Remarks (5 min each)
-HANAKI Izuru, Senior Executive Director, Japan-Taiwan Exchange Association
-Ching-Hung Lin, Deputy Secretary General, Taiwan-Japan Relations Association
12:10-12:50 Keynote speeches-Regulatory updates (40 min)
-Regulatory updates in Japan(15 min)
UZU Shinobu, Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA)
-Regulatory updates in Taiwan(15 min)
Shou-Mei Wu, Director-General, Taiwan Food and Drug Administration (TFDA)
-Q & A, (10min)
【Pharmaceuticals)】
MC:FUKUDA Eriko, International Coordination Officer, PMDA
12:50-13:35 Regulatory challenge against COVID-19 (45 min)
Moderator:Chien-Liang Lin, Director, Division of Medicinal Products, TFDA
-Regulatory Challenge against COVID-19(15 min)
MATSUKURA Yuji, Deputy Director, Office of International Regulatory Affairs, MHLW
-Measures for accelerating vaccine development and challenges of clinical trials(15 min)
Mei-Chen Huang, Section Chief, Division of Medicinal Products, TFDA
-Q & A, (15min)
【Health Insurance)】
MC:FUKUDA Eriko, International Coordination Officer, PMDA
13:35-14:20 Health Insurance (45 min)
Moderator: NAGAOKA Akihiro, Chairman, Asia Committee International Affairs, Japan Pharmaceutical Manufacturers Association (JPMA)
-Drug Pricing System in Japan (15 min)
MIYASHITA Masaya, Section Chief of New Drug Pricing Section in Economic Affairs Division Health Policy Bureau, MHLW
-Updates on Drug Reimbursement Model of Taiwan's NHI System (15 min)
Hsueh-Yung (Mary) Tai, Director of the Medical Review and Pharmaceutical Division of the National Health Insurance Administration (NHIA)
-Q & A, (15min)
【Medical Devices】
MC:FUKUDA Eriko, International Coordination Officer, PMDA
14:20-15:05 Recent Regulatory Challenge in Medical Devices (45 min)
Moderator: Pei-Weng Tu, Director, Division of Medical Devices and Cosmetics, TFDA
-The regulatory perspective of reviewing COVID-19 diagnostic test kits (15 min)
YABANA Naoyuki, Director, Office of In Vitro Diagnostics, PMDA
-The Principle of Reviewing Medical Device Cybersecurity (15 min)
Chun-Jen Chien, Technical Specialist, Division of Medical Devices and Cosmetics, TFDA
-Q & A, (15min)
15:05-15:50 QMS -Utilization of MOC (45min)
Moderator:KUSAKABE Tetsuya, International Cooperation Officer, PMDA
-Current Situation of Utilizing MOC
FUJISAWA Hiroshi, Inspector, Office of Manufacturing Quality and Vigilance for Medical Devices, PMDA (15min)
-QSD Review and Utilization of MOC(15min)
Szu-Yu Lee, Section Chief, Division of Quality Compliance and Management, TFDA
-Q & A, (15min)
【Joint Session】
MC:FUKUDA Eriko, International Coordination Officer, PMDA
15:50-16:00 Closing Remarks (5 min each)
-UZU Shinobu, Senior Executive Director, PMDA
-Shou-Mei Wu, Director-General, TFDA

 

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 限額300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實名簽到。
與會須知 會議進行期間未獲許可,請勿錄音錄影。會議期間請全程配戴口罩。
聯絡窗口 姓名:張專員 或 鍾企劃經理
電話:02-8170-6000 分機 631 或 623
信箱:ccchang469@cde.org.twphchung717@cde.org.tw

 


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