體外診斷醫療器材國際法規及臨床性能評估研討會(07/13)

May 17th, 2016 | Categories: 2016, 其他廣宣 | Tags:

體外診斷醫療器材國際法規及臨床性能評估研討會

Conference on International IVD Medical Devices Regulationsand
C
linical Performance Evaluation

我國衛生福利部食品藥物管理署自2012年起獲選擔任亞洲醫療器材法規調和會(Asia Harmonization Working Party, AHWP)副主席及該組織轄下技術委員會體外診斷醫療器材工作小組(WG2- Premarket: IVDD)主席,主導 AHWP體外診斷醫療器材工作小組於國際醫療器材法規之調和任務。

工業技術研究院量測技術發展中心接受衛生福利部食品藥物管理署委託,舉辦「體外診斷醫療器材國際法規及臨床性能評估研討會」,邀請美國、巴西、韓國、泰國、澳洲、中東地區及 ISO/ TC 212等多國代表,針對各國目前體外診斷醫療器材法規及臨床性能評估要求與發展等主題,進行交流與分享。

本研討會除提供AHWP WG2 體外診斷醫療器材工作小組及WG5臨床性能/安全工作小組教育訓練外,亦提供平台讓國內外體外診斷醫療器材相關業者瞭解國際最新法規管理資訊。藉由參與會議與各國衛生主管機關及國內外醫療器材企業人士交流,建立法規溝通管道。敬請踴躍報名。

 

主辦單位/ Hosted by

衛生福利部食品藥物管理署

Food and Drug Administration, Ministry of Health and Welfare

承辦單位/ Organized by

工業技術研究院量測技術發展中心
Center for Measurement Standards / Industrial Technology Research Institute

日期/ Date

105713日(三)/ July 13, 2016 (Wednesday))

地點/ Venue

臺大醫院國際會議中心401會議室 (臺北市中正區徐州路2)
Room 401, NTUH International Convention Center
(No. 2, Xuzhou Road, Zhongzheng District, Taipei, Taiwan R.O.C.)

報名截止日期/ Registration Deadline

10578日(五)/ Jul 8, 2016 (Friday)

費用/ Registration Fee

免費/ Free

報名網址/ Online Registration

https://wlsms.itri.org.tw/ForeSignUp/SignUpIndex.aspx?ActGUID=20564F00C6

本研討會名額有限,敬請及早報名。已確認參加資格之與會人員若不克出席,請通知承辦單位或逕行指派代表參加。

本研討會全程以英文進行,備有英翻中同步口譯。

*本研討會提供上下午茶點、飲料,不提供午餐。

*本研討會全程免費並備有講義。現場報名者或未準時報到者,不保證提供講義。

*主辦單位保留變更研討會議程、講題及講者之權利。若有任何未盡事宜,主辦單位亦保有隨時補充、說明、修改之權利。

*報名成功者,承辦單位將於活動前2日,以e-mail方式寄發「報到通知」。如未收到,請主動來電洽詢。

*若有任何問題,請洽承辦單位工業技術研究院量測技術發展中心劉小姐。

     TEL(03) 5743771 E-mailcs1108@itri.org.tw

 

Agenda

Time Topics Speaker
0850~ 0920

Registration

0920~ 0930 Opening Remarks FDA, MOHW, Taiwan (to be confirmed)
0930~ 0940

Group Photo Taking

AHWP TC WG2 & WG5 Activities

0940~ 1000 AHWP TC WG2 (Pre-market: IVDD) Activities Update Dr. Wen-Wei TSAIAHWP TC WG2 Chair

Technical Specialist

Division of Medical Devices and Cosmetics, FDA, MOHW, Taiwan

1000~ 1020 AHWP TC WG5 (Clinical Performance & Safety) Activities Update Ms. Yuwadee PATANAWONGAHWP TC WG5 Chair

Senior Expert in Medical Device Safety

Medical Devices Control Division

Food and Drug Administration

Thailand

1020~ 1030

Tea Break

IVD Regulatory Updates

1030~ 1110 A Status Update and Overview on Thailand IVD Medical Devices Regulations Ms. Yuwadee PATANAWONGAHWP TC WG5 Chair

Senior Expert in Medical Device Safety

Medical Devices Control Division

Food and Drug Administration

Thailand

1110~ 1210 A Status Update and Overview on Brazil IVD Medical Devices Regulations Mr. Augusto Bencke GeyerOffice of In Vitro Diagnostics

Agência Nacional de Vigilância Sanitária (ANVISA), Brazil

1210~ 1310

Lunch Break

1310~ 1410 A Status Update and Overview on Korean IVD Regulations Mr. Young-wook AHNAssistant Director, MFDS, Korea
1410~ 1510 A Status Update and Overview on IVD Regulations In Middle East Mr. Sanoj PRABHAKARANRegulatory Affairs Manager M.E.

& Turkey, Corporate/Shared Services, Becton Dickinson

1510~ 1530

Tea Break


IVD Clinical Performance Evaluation

1530~ 1630 The Development of IVD Medical Device Clinical Performance Evaluation (ISO NWIP 20916: Clinical Performance Studies for In Vitro Diagnostic Medical Devices (IVDs) Using Specimens from Human Subjects – Good Study Practice) Ms. Shelley TANGProject lead of ISO/TC 212 WG3 NWIP 20916

Principal, Stellar Consulting Pty Ltd, Australia

1630~ 1730 US FDA’s Approach to In Vitro Diagnostic Medical Device Clinical Performance Evaluation Ms. Karen ROBERTSDeputy Convenor for ISO/TC 212 WG3

Director, Design Quality R&D, Roche Diagnostics

1730~ 1740 Closing Remarks FDA, MOHW, Taiwan (to be confirmed)

 

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