From Asia to the World: Global Integration of Clinical Research

張貼者:2010年7月13日 下午9:38林昆儒   [ 已更新 2010年7月16日 上午9:29 ]
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
TimeTopic
09:00 ~ 09:30Global 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 ~ 10:00Fast Track to Obtaining the Asia Markets: Planning Your Clinical Studies the Efficient Way
Ms. Ammy Chiou, Medical Director, Daiichi Sankyo Taiwan Ltd.
10:00 ~ 10:20Break
10:20 ~ 10:50Global Outsourcing Trends Today II: Collaborative Models for Biopharmaceutical Companies and CROs
Ms. Catherine Lee, Area Head, Clinical Operations-Asia, Pfizer Ltd. Taiwan
10:50 ~ 11:20Panel Discussion – All Session One Presenters
Moderator: Mr. Albert Liou, Corporate Vice President & General Manager, Asia Pacific, PAREXEL International
11:20 ~ 12:00Partnering 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 ~ 13:30Lunch
13:30 ~ 14:00Experience Sharing on FDA Inspections
Ms. Vicki Liao, Director, On Site Monitoring, PAREXEL International
14:00 ~ 14:30A 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 ~ 15:00Panel Discussion – All Session Two Presenters
Moderator: Dr. Alberto Grignolo, Corporate Vice President, Global Strategy, PAREXEL Consulting
15:00 ~ 15:30Day Two Recap / Event Closing



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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