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 : 3680 次
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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) |
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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) |
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線上視訊 |
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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 |
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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 |
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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 |
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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 |
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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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