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0401 | 信息化技术的应用,提高临床试验数据质量 - 第一部分:临床研究信息一体化

时间: 05 月 22 日 08:30 - 10:00
内容介绍:

分会场主持人

盛锋 工商管理硕士

OmniComm Systems公司商务开发中国区总经理


药物研发的过程越来越复杂, 数据量也越来越多。传统的药物研发管理模式已经无法适应复杂的流程与海量的信息。信息在采集、管理、整合、共享、汇总与监控等方面给管理者带来了巨大的压力。因此, 利用信息化技术管理临床研究过程与数据, 及时为研发管理者的决策

提供可靠的数据基础, 这已经成为我国临床研究的一个迫切要求。 本部分将分享信息化企业的经验与体会。


临床研究信息一体化的进展与趋势

Jeyaseelan JEYARAJ

甲骨文亚太区方案咨询高级总监


临床研究的信息一体化: 实践与体会

庄永龙 博士

北京百奥知信息科技有限公司总经理


专家讨论: 临床研究信息一体化的难点与重点

特邀讨论嘉宾

付海军

上海韧致医药科技有限公司首席运行官、公司创始人


范志孝

复星医药易研云(上海)医疗科技有限公司销售和战略部副总裁


富春枫

科文斯临床数据管理(中国及澳大利亚)高级总监


日程嘉宾
2019 DIA中国年会/ 2019 DIA China Annual Meeting
Jeyaseelan JEYARAJ
甲骨文亚太区方案咨询高级总监
Jey is a Senior Director in the Health Sciences Global Business Unit at Oracle Corporation. His current responsibilities include thought leadership, product strategy and solutions consulting across Oracle’s Health Sciences product portfolio including the areas of eClinical and Safety, Clinical Data warehouse, Analytics and Translational Research. Jey is a renowned healthcare informatics expert on addressing the challenges facing the global healthcare industry and prospects for improving patient outcomes through better use of healthcare data and information. Jey brings in 18 years of broad experience in Pharmaceutical R&D that spans venture-funded biotech, large pharma, CRO and Healthcare Providers. He has published several papers and articles on personal health technologies and co-authored many reports on e-health technologies. Jey holds a Master’s degree in Computer Applications from St. Joseph’s College, Tiruchirappalli and General management from the Indian Institute of Management (IIM), Calcutta. He has been associated with leading industry bodies in Healthcare and Life Sciences. Jey is a frequent speaker about biopharmaceutical trends and strategy in industry conferences. He is currently the President of HIMSS Asia Pacific India and also serving as the Healthcare Policy Chair of HIMSS Asia Pacific India.
2019 DIA中国年会/ 2019 DIA China Annual Meeting
庄永龙
北京百奥知信息科技有限公司总经理
庄永龙,北京百奥知信息科技有限公司创始人,清华大学博士, 曾参与“十一五”、“十二五”科技重大专项《艾滋病和病毒性肝炎等重大传染病防治专项》、参与“十二五”科技重大专项《重大新药创制》、“十一五”重大项目《重大疾病的分子分型和个体化诊疗》信息专题“疾病分子分型标准化与软件开发”负责人,“863”生物医药信息专题评审专家。 庄博士在国内外期刊上发表多篇论文,主导、参与多项国家863、973、自然科学基金等重要项目,在软件设计、统计分析、数据管理、数据挖掘、生物医学、方案设计、生物信息分析等交叉学科有20年的经验。
2019 DIA中国年会/ 2019 DIA China Annual Meeting
付海军
CEO, Shanghai Zenith Medical Tech, Co, Ltd
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.
2019 DIA中国年会/ 2019 DIA China Annual Meeting
范志孝
易研云(上海)医疗科技有限公司副总裁
多年生命科学和大健康行业信息化经验,在药品和医疗器械的研发、生产和流通方面具有丰富管理咨询和系统实施经验,为多家药企提供过专业服务。对项目管理、数据管理、数据挖掘、人工智能、专家系统尤有心得。
2019 DIA中国年会/ 2019 DIA China Annual Meeting
富春枫
科文斯临床数据管理(中国及澳大利亚)高级总监
Education MS in Epidemiology and Statistics from Nanjing Medical University BS in Public Health from Nanjing Railway Medical College Previous employment Director & Wuhan Site Head at WuXi CDS Associate Director of Clinical Data Management at Quintiles DOL at Parexel Associate Manager at EPS Responsibilities Act as the Site Head of Dalian GSDM, with full responsibility for the P&L of Dalian GSDM operations. Provide leadership and strategic direction for Dalian GSDM. Act as a member of the senior leadership team in Global PSSDS and CDS China. Lead and mentor Dalian GSDM personnel. Hire, train, develop and retain the top talents for Dalian GSDM. Build successful working relationships with global biometrics functions and other business and scientific leaders across Covance. Build successful business relationships with major clients, especially their biometrics function leaders.
2019 DIA中国年会/ 2019 DIA China Annual Meeting
盛锋
Ominicom Systems Inc公司商务开发中国区总经理
Mr. Feng Cheng is the General Manager of China for OmniComm Systems, Inc. OmniComm Systems is a leading strategic software solutions provider to the life sciences industry. OmniComm provides comprehensive solutions for clinical research with an extensive global experience from over 5,000 clinical trials. Prior to OmniComm Systems, Mr. Cheng was a Sr. Director at Vertex Pharmaceuticals Inc., a major BioTech company in Boston, Massachusetts. At Vertex Pharmaceutical Inc., Feng managed a large IT department that supported a few hundreds end-users in General Administration, Drug Discovery, and Drug Development areas as well as 1,500 end-users at Vertex’s global sites. Feng Cheng started his carrier with Warner-Lambert Co. over 20 years ago. His responsibility there was to manage all discovery and development systems. He was successfully developed and implemented GLP and GMP systems. Mr. Cheng has broad experience at BioTech and Pharmaceutical industry. He has more than 20 years experience in all aspects of drug discovery and development, including GxP environments, Enterprise Resource Planning, Laboratory Information Management, Electronic Document Management, Clinical Data Management, Clinical Safety, Quality Management, Learning Management, ITIL and IT systems such as Portals, UNIX, Linux, TCP/IP, DHCP, WINS, DNS, RAID, LAN, WAN. Mr. Cheng received a B.S. in Chemical Engineering, a MS in Computer Science, and a MBA.