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演講者
Bruce Xue
Biostatistical Manager, Medical Affairs Department
Xian-Janssen Pharmaceutical
Charles Yan
Senior Director, Clinical Data Management
Shanghai Clinical Research Center
Charlie Chen
Vice President
GCP ClinPlus
Charlie Xu
Vice President
Frontage Clinical Services
Ian O’Shaughnessy
Director, Data Management Asia Pacific
ICON Clinical Research
Christopher Huang
Founder & General Manager
Pharmacons Tech
Deng YaZhong
Head of CDARO China
Covance
藉由有效進行治療效驗數據的收集、分析、管理,能提高數據品質、節減經費、使臨床檢驗效率化、以及縮短開發時間等
是聚焦於治療效驗數據的收集與管理、亞洲唯一的活動
現在生物醫藥品業界已體認到臨床數據是企業的重要資產。然為了以迅速且柔軟的方法進行研究開發階段化合物的評價,製作更優良的臨床檢驗計劃書,推動創新的研究構想和新的臨床計畫,以及強化臨床產品的管道,具備將這些數據轉換成有意義的資訊之能力就變得極為重要。
近幾年亞洲實施臨床檢驗的件數有增加傾向,提高數據收集和管理之整合性、品質和效率,維持可因應初期產品登記和投入市場後的利用之整合化資料庫,是使投資收益提高到最大限度的重要前提條件。
2011年12月舉行的第2屆Data Collection and Management in Clinical Trials Asia中,亞洲和世界各地參與臨床數據處理業務者為克服收集臨床數據和管理現場面臨的技術與法規、策略、及預算面的重要課題,針對重要策略展開討論。
此次的會議預定舉行由業界內擔任主導性作用的專家和意見領袖進行充滿暗示性的個案研究與專題討論會。
可登記個別參加的2個研究會
成為數據管理領域下一代龍頭—在新市場晉升為上級主管需具備的本領
研究會的講師
Pfizer (China) Research & Development Center
Head of Global Clinical Data Services
Jessie Chen先生
基於臨床數據管理效率化來改善臨床檢驗實施體制
研究會的講師
Genzyme Pharmaceuticals
Associate Director, Standard Programme Manager
Julia Zhang先生
此會議值得一看的地方
- 驗證美國食品藥品管理局(FDA)顯示的必要條件及對患者數據報告業務的影響。
- 能加深理解有關募集參加臨床檢驗的患者和收集數據之醫藥品臨床檢驗的實施基準(GCP)。
- 能掌握Clinical Data Interchange Standards Consortium(CDISC)的最新動向。
- 克服重複癌臨床檢驗數據面的課題,能找出適合國際性法規基準的方策。
- 考慮有關統計計畫開發業務之最佳境外外包(offshoring)模式。
請勿錯過能在成長顯著的亞洲臨床數據收集/管理市場提高競爭力的此寶貴機會。
What Data Collection and Management in Clinical Trials Asia 2010’s participants Had To Say About The Event?
"Very insightful to the region and the challenges and opportunities here. Asia is as new area for DM support and some local challenges need to be understood."- Bio Pharmaceutics Director, Eli Lilly and Company
"Valuable. Many experienced people shared their valuable experience for data management work"-Data Manager, Fu Wai Hospital
"The event has been valuable in terms of networking, making new contacts, meeting up with global colleagues and gaining an insight of the clinical trial opportunities available in China."- Data Management Executive Director, Pharmanet Ltd
"Very valuable because very focussed and interactive." - CDM Senior Manager, RPS
"Good learning for Chinese trends. Good learning from Q&A from the floor"- Japan Clinical Lead, Pfizer Japan
"Good start. This is one of the few conference focuses on data management. Let’s keep up the momentum. Overall good conference"- Senior Director and Regional Head, Quintiles
"Meeting with experience people in the industry and networking many interesting discussion"- Head of Biometrics and Medical Writing, Lundbeck Singapore
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