第九屆台日醫藥交流會議 9th Joint Conference of Taiwan and Japan on Medical Products Regulation

刊登日期：2021-09-11 | 點閱次數 : 3053 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：	線上視訊
活動日期：	110年10月14日(四)12：30~17：50

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「第九屆台日醫藥交流會議」，訂於2021年10 月14日（星期四），以線上視訊方式舉辦，議程如下，本屆會議由台方主辦，配合時差緣故，將於台灣時間當天中午12時30分正式開始。

因應COVID-19疫情，台灣與會者將透過線上視訊方式與日方代表交流。線上會議將提供中文、日文語音同步口譯。本會議不收取任何費用，本場次限額700 名，為免向隅，敬請及早報名。線上會議連結網址將於會前另以Email通知。

會議議程

【Joint Session】
Opening Remarks
12:30-12:40 (TW) 13:30-13:40 (JP)	Mr. Ching-Hung Lin, Deputy Secretary General, Taiwan-Japan Relations Association Mr. HANAKI Izuru, Senior Executive Director, Japan-Taiwan Exchange Association
Keynote speeches
12:40-12:55 (TW) 13:40-13:55 (JP)	Regulatory updates in Taiwan	Dr. Shou-Mei Wu, Director-General, TFDA
12:55-13:10 (TW) 13:55-14:10 (JP)	Regulatory updates in Japan	Mr. UZU Shinobu, Senior Executive Director, PMDA
13:10-13:20 (TW) 14:10-14:20 (JP)	Q&A

【Pharmaceuticals】
Moderator: Mr. Chien-Liang Lin, Director, Division of Medicinal Products, TFDA
13:20-13:35 (TW) 14:20-14:35 (JP)	Measures for Clinical Trials during COVID-19 Pandemic	Ms. Ting-Ya Chang, Associate Researcher, Division of Medicinal Products, TFDA
13:35-13:50 (TW) 14:35-14:50 (JP)	COVID-19 Measures in Japan (TBC)	Mr. MATSUKURA Yuji, Deputy Director, Office of International Regulatory Affairs, MHLW
13:50-14:00 (TW) 14:50-15:00 (JP)	Q&A
Moderator: TBC, MHLW/PMDA
14:00-14:15 (TW) 15:00-15:15 (JP)	Regulation of Orphan Drugs in Taiwan	Dr. Yin-Hsiu Chien, Department of Medical Genetics and Pediatrics, NTUH
14:15-14:30 (TW) 15:15-15:30 (JP)	Regulatory approach to promote orphan drug development in Japan	Dr. AOI Yoko, Principal Reviewer, Office of New Drug V, PMDA
14:30-14:40 (TW) 15:30-15:40 (JP)	Q&A

【Health Insurance】 Moderator: Mr. Chien-Liang Lin, Director, Division of Medicinal Products, TFDA
14:40-14:55 (TW) 15:40-15:55 (JP)	The Strategies for Enhancing Access to New Drugs and Reimbursement Efficiency in Taiwan’s NHI System	Hsueh-Yung Tai, Director, Division of Medical Review and Pharmaceutical Benefits, NHIA
14:55-15:10 (TW) 15:55-16:10 (JP)	TBC	TBC, MHLW
15:10-15:20 (TW) 16:10-16:20 (JP)	Q&A

【Medical Devices】
Implementation for new medical devices regulation Moderator: TBC, MHLW/PMDA
15:20-15:35 (TW) 16:20-16:35 (JP)	Medical Device Act and Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration	Dr. Yu-Ping Hsieh, Reviewer Division of Medical Devices and Cosmetics, TFDA
15:35-15:50 (TW) 16:35-16:50 (JP)	Regulation system and perspective of SaMD (TBC)	Dr. OKAZAKI Yuzuru, Director, Office of Software as a Medical Device, PMDA
15:50-16:00 (TW) 16:50-17:00 (JP)	Q&A
Emerging topics Moderator: Ms. Pei-Weng Tu, Director, Division of Medical Devices and Cosmetics, TFDA
16:00-16:15 (TW) 17:00-17:15 (JP)	UDI Regulations in Taiwan	Mr. Ching Chou, Associate Reviewer Division of Medical Devices and Cosmetics, TFDA
16:15-16:30 (TW) 17:15-17:30 (JP)	Approach to regulation for NGS-based oncology panel products in Japan (TBC)	Dr. YABANA Naoyuki, Director, Office of In Vitro Diagnostics, PMDA
16:30-16:40 (TW) 17:30-17:40 (JP)	Q&A

【Joint Session】
Closing Remarks
16:40-16:50 (TW) 17:40-17:50 (JP)	1. Dr. Shou-Mei Wu, Director-General, TFDA 2. Mr. UZU Shinobu, Senior Executive Director, PMDA

報名資訊

報名方式	本課程僅由線上報名，恕不接受電話或其他方式報名。
報名人數	本活動採線上視訊方式辦理，限額700人。承辦單位亦得視狀況隨時截止報名，並保留報名資格之最後審核權利。
報名時間	自公告日起至110年10月7日(四)17:00
報名費用	不需繳納費用。
與會須知	1. 會議進行期間未獲許可，請勿錄音錄影。 2. 視訊會議與會網址將於活動前另以Email通知，報名時請務必留下正確Email。
聯絡窗口	姓名：張佳綺或鍾佩樺電話：02-8170-6000 分機 631 或 623 信箱：ccchang469@cde.org.tw、phchung717@cde.org.tw

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