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分会场0508-1:肿瘤临床试验中的数据管理

(二层, 203AB)

时间: 05 月 25 日 15:30 - 17:00
内容介绍:

分会场主持人


邓亚中 工商管理硕士

北京信立达医药科技有限公司首席执行官


肿瘤临床试验相比于其他临床试验,收集数据多、周期长、不良事件和合并用药比较多,所以数据管理过程相对较为复杂。如何收集、管理和提交高质量的临床试验数据面临较多挑战。本专题将专门针对肿瘤临床试验的数据收集、数据清理以及数据质量的审核进行介绍和实例分享。


怎样在肿瘤试验中设计CRF


王宏伟

百济神州数据管理总监


肿瘤试验中数据清理的挑战


付海军 博士

上海韧致医药科技有限公司首席执行官



肿瘤临床试验中数据管理的综合审核及质量监管


廖梦妮

北京信立达医药科技有限公司高级数据管理经理

日程嘉宾
2018第十届DIA中国年会
邓亚中 工商管理硕士
北京信立达医药科技有限公司首席执行官
Head of Clinical Data Analysis and Reporting Organization (CDARO), Covance, China Yazhong DENG is Head of Clinical Data Analysis and Reporting Organization (CDARO) in Covance China. Yazhong joined Covance in 2008 and set up the CDARO team in China. Within 2 years, he has successfully to expand the team to 100 employees now. Prior to Covance, Yazhong worked in an Asian CRO (Gleneagles CRC) for 7 years. He has been in different positions: Biostatistician, Data Manager, Biometrics manager, Regional head of Biometrics and General Manager for China office. Yazhong got his master degree of Biostatistics in Chinese Academy of Preventive Medicine, and degree of clinical epidemiology from Erasmus University Rotterdam. Yazhong also hold a MBA from Peking University. He is always actively involved in developing industry association in China, i.e.: Beijing Biometric Forum (BBF), C3C, and Data Management China Network (DMCN).
2018第十届DIA中国年会
王宏伟
百济神州数据管理总监
Hongwei Wang Director, Head of Data Management, BeiGene 12+ years of experience in clinical development in global Pharma and CROs, including biostatistics, SAS programming and data management. He joined BeiGene as head of data management in 2017, prior to BeiGene, he is head of China data management at Covance China, responsible to oversight Data Management Operations and Database Design team, with more than 60 team members. He also worked for Merck Serono and PRA (formerly RPS) as data management manager.
2018第十届DIA中国年会
付海军 博士
上海韧致医药科技有限公司首席执行官
HADRIAN FU 付海军 EDUCATION BACKGROUND: 1996-9→2001-6: Ph.D Department of Epidemiology and Biostatistics, Shanghai Medical Univ, China 1991-9→1996-6: B.S, M.D Zhejiang Medical Univ, China WORK EXPERIENCES: Company Position 2015-7 – Present Shanghai Zenith Medical Tech, Co, Ltd CEO 2004-7 - 2015-7 Shanghai CARES Bio-tech, Co, Ltd General Manager 2001-4 - 2004-7 Clinical Research Center, AAI China, AAIPharma Executive Director MEMBERSHIP • Secretary of Clinical Data Management working group of China • Vice secretary general of bio-statistics working group of China medical education association • Member of CFDA data management & bio-statistics guideline committee • Member of china steering committee of SCDM • Member of Medical Data Analysis Committee, China Association for Medical Devices Industry (CAMDI) • Member of Clinical Research Branch, China Information Association For Traditional Chinese Medicine and Pharmacy • Member of Clinical Research Committee, Shanghai Pharmaceutical Association EXPERIENCE: • More than 450 clinical studies from Phase I to IV covering most therapeutic areas.