時間(TIME) 演講主題與主講人(TOPICS / SPEAKERS)
09:00~09:30 簽到/合影 REGISTRATION / PHOTO
09:30~09:50

貴賓致詞 OPENING REMARKS
主講人:衛生福利部食品藥物管理署 醫蛢 劉麗玲組長
Speaker:Ms. Li-Ling Liu,
Director, Division of Medical Devices and Cosmetics,
Taiwan Food and Drug Administration, Ministry of Health and Welfare

主持人:美國醫療法規學會台灣分會理事長/財團法人自強工業科學基金會執行長/
國立清華大學動力機械工程學系 蕭德瑛教授
Session Chairman:Dein Shaw, Ph. D.,
Chairman of RAPS Taiwan /CEO of Tze-Chiang Foundation of Science & Technology
Professor of Institute of Power Mechanical Engineering, National TsingHua University, Taiwan
09:50~10:50 中國大陸醫療器械監管與法律制定走向
Management and Trend in Law-Making of Medical Device Industry in China

主講人:上海市食品藥品監督管理局 唐民皓副局長
Speaker:Mr. Tang Minhao,
Deputy Director-General of Shanghai Municipal Food and Drug Administration(SMFDA)
11:00~12:00 亞太醫療器材法規調合現況與趨勢
The Harmonization Trends of Medical Device Regulations in Asia-Pacific

主講人:財團法人醫藥品查驗中心 醫療器材組 王明哲組長
Speaker:Ming-Che Wang, Ph.D.,
Director, Division of Medical Devices, Center for Drug Evaluation (CDE), Taiwan
12:00~13:10 午餐 LUNCHEON
主持人:亞洲醫療器材法規調和會(AHWP) 王龍副總裁
Session Chairman:Mr. Jack Wong,
Vice President of Asia Harmonization Working Party (AHWP)
13:10~14:10 日本醫療器材藥事法未來展望與產品上市前檢驗評估需求
On-going revision of Pharmaceutical Affairs Law for medical device and requirement of premarket Assessment

主講人:
日本厚生勞動省醫藥食品局醫療機器審查管理室 審查管理課
近藤英幸 (Hideyuki Kondo)副處長
Speaker:Mr. Hideyuki Kondo,
Deputy Director of Office of Medical Device Evaluation, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare(MHLW), Japan.
主講人:
日本獨立行政法人醫藥品醫療機器總合機構國際業務調整役(醫療機器擔當)
Madoka Murakami博士
Speaker:Ms. Madoka Murakami,
Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
14:10~15:10 中國大陸醫療器械產品上市許可相關法規介紹
Introduction of Regulations in Marketing Approval of Medical Device Products in China

主講人:上海市食品藥品監督管理局醫療器械註冊處 林峰處長
Speaker:Mr. Lin Feng,
Director, Division of Medical Devices Registration, Shanghai Municipal Food and Drug Administration (SMFDA)
15:10~15:20 休息 BREAK
15:20~16:20 上海醫療器械市場現狀與監管政策
Current Situation of Medical Device Market and Regulatory Policies in Shanghai

主講人:上海市食品藥品監督管理局流通管理處 王燕處長
Speaker:Ms. Wang Yan,
Director, Division of Circulation, Shanghai Municipal Food and Drug Administration (SMFDA)
16:30~17:00 Q & A
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時間(TIME) 演講主題與主講人(TOPICS / SPEAKERS)
09:20~09:50 簽到 REGISTRATION
主持人:財團法人醫藥品查驗中心醫療器材組 王明哲組長
Session Chairman:Ming-Che Wang, Ph. D.,
Director, Division of Medical Devices, Center for Drug Evaluation (CDE), Taiwan
09:50~10:50 日本高階醫療產品開發歷程
Development Process of High-level Medical Product in Japan

主講人:RAPS日本總會代表/東京女子醫科大學先端生命醫科學研究所 江上美芽(Mime Egami)客員教授
Speaker:Mime Egami, Ph. D., President of RAPS Japan /
Visiting Professor and Chief Medical Innovation Officer,
Tokyo Women’s Medical University
10:50~11:50 泰國醫療器材產品臨床前試驗與安全性確效
Pre-clinical Testing and Safety Validation of Medical Device Products in Thailand

主講人:泰國食品藥物管理局公共健康部 Yuwadee Patanawong資深專家
Speaker:Ms. Yuwadee Patanawong,
Senior Expert in Medical Device Safety, Food and Drug Administration, Ministry of Public Health, Thailand
11:50~13:00 午餐 LUNCHEON
主持人:美國醫療法規學會台灣分會 理事/國立清華大學生物科技研究所 吳夙欽教授
Session Chairman:Suh-Chin Wu, Ph. D.,
Executive Director of RAPS Taiwan /
Professor of Institute of Biotechnology, National Tsing Hua University, Taiwan
13:00~14:00 亞太地區醫療法規專業人才培育與認證
Certification and Incubation of Regulatory Professionals of Medical Device Industry in Asia-Pacific region

主講人:亞洲醫療器材法規調和會(AHWP) 王龍副總裁
Speaker:Mr. Jack Wong,
Vice President of Asia Harmonization Working Party (AHWP)
14:00~15:00 醫療器材之法規申請常見障礙與對策
Introduction of Global Medical Device Regulations - Common issues and Suggestions

主講人:優力國際安全認證有限公司(UL) 亞太區醫療科學部 王舜民營運協理
Speaker:Mr. Samuel Wang,
Director, Health Sciences, Asia Pacific, Underwriters Laboratories Taiwan Co., Ltd.
15:00~15:10 休息 BREAK
15:10~16:10 台灣醫療器材育成經驗分享
Experience Sharing for Incubation of Medical Device Star-up Companies in Taiwan

主講人:台灣生技整合育成中心技術長
國立成功大學生物醫學工程學系 陳家進特聘教授
Speaker:Jia-Jin J. Chen, Ph. D.,
CTO of Supra Integration and Incubation Center
Distinguished Professor of Department of BioMedical Engineering, National Cheng Kung University
16:10~16:50 綜合論壇 FORUM
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主辦單位(Hosted by)
衛生福利部食品藥物管理署
Taiwan Food and Drug Administration, Ministry of Health and Welfare
承辦單位(Organized by)
財團法人自強工業科學基金會
Tze-Chiang Foundation of Science & Technology(TCFST)
協辦單位 (Co-Sponsored by)
美國醫療法規學會 Regulatory Affairs Professionals Society(RAPS)
美國醫療法規學會台灣分會 RAPS Taiwan
美國醫療法規學會日本分會 RAPS Japan
國立清華大學(NTHU)National Tsing Hua University(NTHU)
上海理工大學(USST)Shanghai for Science and Technology (USST)
 活動日期(Date):10.29(Tue.)~ 10.30(Wed.)
 活動地點(Location):台大醫院國際會議中心201會議廳  (台北市中正區徐州路2號)
 活動費用(Registration Fee):完全免費。現場備有同步翻譯(英翻中)設備。
 諮詢專線(Tel):(03) 573-5521 Ext. 3237 蘇小姐   E-mail: hwsu@tcfst.org.tw
 活動網址:http://edu.tcfst.org.tw/edm/02B334.asp
 報名方式:名額有限,額滿為止。一律網路報名,恕不接受其他方式。102年10月23日截止報名。
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