張貼者：2010年7月13日 下午9:38林昆儒
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已更新 2010年7月16日 上午9:29
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這是一個由台大醫院，TAIRB, 以及PAREXL international 所共同舉辦的"立足亞洲，放眼全球"，促進臨床研究之整合的論壇。 這次會議共有近300人報名，70%大多是CRO公司的亞洲代表，也有15%的政府代表，以及15%的醫療工作人員！ 而長庚醫院這次也有包括我以及張啟仁教授的兩位演講者與會。兩天的課程也取得了15小時的人體試驗倫理學分！
張啟仁教授報告了 electronic data capture 台大則報告了腫瘤科的phase I study 經驗！
我則負責分享本科的 inspection 經驗！這次的會議全程得用英文演講，說的又是跟醫療較無關的議題，真是折煞人！
| Day Two – Friday, July 16, 2010 | | Time | Topic | | 09:00 ~ 09:30 | Global Outsourcing Trends Today I: Insourcing or Outsourcing? Cost Efficient Ways of Conducting Clinical Trials
Dr. Karen Chu, Vice President, Project Management, Regional Project Leadership Heads, PAREXEL International | | 09:30 ~ 10:00 | Fast Track to Obtaining the Asia Markets: Planning Your Clinical Studies the Efficient Way
Ms. Ammy Chiou, Medical Director, Daiichi Sankyo Taiwan Ltd. | | 10:00 ~ 10:20 | Break | | 10:20 ~ 10:50 | Global Outsourcing Trends Today II: Collaborative Models for Biopharmaceutical Companies and CROs
Ms. Catherine Lee, Area Head, Clinical Operations-Asia, Pfizer Ltd. Taiwan | | 10:50 ~ 11:20 | Panel Discussion – All Session One Presenters
Moderator: Mr. Albert Liou, Corporate Vice President & General Manager, Asia Pacific, PAREXEL International | | 11:20 ~ 12:00 | Partnering for Success between Agency and Industry
Dr. Chih-hwa Wallace Lin, Sr. Researcher and Director, Division of Resource Development, Center for Drug Evaluation, Taiwan | | 12:00 ~ 13:30 | Lunch | | 13:30 ~ 14:00 | Experience Sharing on FDA Inspections
Ms. Vicki Liao, Director, On Site Monitoring, PAREXEL International | | 14:00 ~ 14:30 | A Site’s Experience Sharing on Inspections
Dr. Kun-Ju Lin, Assistant Professor and Director, Department of Nuclear Medicine, Keelong Chang Gung Memorial Hospital | | 14:30 ~ 15:00 | Panel Discussion – All Session Two Presenters
Moderator: Dr. Alberto Grignolo, Corporate Vice President, Global Strategy, PAREXEL Consulting | | 15:00 ~ 15:30 | Day Two Recap / Event Closing
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 | Market trend on simultaneous global development | | eClinical technologies and improving productivity and cost efficiency through its implementation | | Early phase drug development trends in Asia | | Asia regulatory updates and consideration when building your drug development plans | | Global outsourcing trends - Insourcing or outsourcing and how to choose the right fit partner for your appropriate studies | | Experience sharing from key opinion leaders and global biopharmaceutical companies on conducting multi-national clinical trials
Conference Link
講義PDF下載 (內部網頁) |
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