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活動訊息

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 : 2649 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1230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.twphchung717@cde.org.tw

 


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