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临床数据管理2022年度大会

Clinical Data Management 2022 China Conference

Jul 7-9, Shanghai |7月7-9日 上海

DHT与临床数据管理

DHT and Clinical Data Management

会议背景| BACKGROUND:

以人工智能、大数据、云计算等为代表的新一代信息技术发展迅猛,带动了各产业的变革,已在临床研究领域产生了深远影响,驱动临床研究工作流程和管理模式的转变与创新。在数字健康时代日新月异发展的大背景下,临床数据管理能否高效融入数字浪潮,通过技术、流程的不断优化和创新,实现数据管理的质量和效率的提升?同时,行业人员又该如何适应不断变化的形势和众多挑战,提高自身素养和专业技能以应对数字健康时代高质量发展要求?这些都成为当下行业关注的热点。

The rapid development of the information technology represented by artificial intelligence, big data, cloud computing, etc. has driven changes in various industries, and has greatly impacted clinical research, and driven the transformation and innovation of its workflow and management mode. In digital era, whether CDM can efficiently integrate into it, and improve the quality and efficiency of the data management through continuous optimization and innovation of technologies and processes? At the same time, how should industry fellows adapt to the ever-changing situation and challenges, and improve their own professional skills to meet the development requirements in the digital health era? These have become the hot topics in the industry now.

临床数据管理2022年度大会将于77-9中国上海举办,本届大会主题为“DHT与临床数据管理”。届时受邀的国际国内行业专家们将围绕直接数据采集技术和合规性探讨、临床结局评估的开发标准和应用、利用信息化技术,提升数据管理工作的效率与质量、数字化时代DM专业能力进阶等多个热点议题,探讨数字时代下技术变革带来的挑战、机遇和应对策略。

Clinical Data Management 2022 China Conference will be held in Shanghai, China from July 7 to 9, 2022, themed “DHT and Clinical Data Management”. The invited international and domestic experts will discuss about challenges, opportunities and corresponding tactics brought by the technology innovation under digital era. Hot topics cover E2E Data Collection Technology and Compliance, COA Design and Application, Information Technology to Enhance Data Management Efficiency & Quality, Advancing DM Expertise in Digital Era, etc.

本届大会还将在7月7日开展会前培训和研讨,专题包含:还在用Excel做dashboard吗?专家教你如何轻松实现临床数据管理可视化、CDISC临床数据采集标准(CDASH)介绍与建库自动化考量以及技术赋能人才转型:手把手教你掌握高效率Data Review技巧等四个专题,由具有实操经验的临床数据管理资深专家现场授课,助力数据管理人员提档转型。

Three parallel tracks of pre-conference workshops will be arranged on July 7. Topics include Expert teach you how to realize visualization in Clinical Data Management, Introduction of CDASH and its application in automated database setup and Technology empowers people transformation: Hands on Training on Cross Check/Listing. Instructors with hands-on experience will give lectures, facilitate your study and help you skill up.

会议亮点 | CONFERENCE HIGHLIGHTS:

  1. 了解数据管理工作中如何利用信息技术实现数据管理效率与质量的提升,并为企业业务与员工的发展提供充足的空间
    Study how to use information technology to improve the efficiency and quality of clinical data, and how information technology can help to provide sufficient space for business and employee career development
  2. 通过EMEA相关法规与案例分享,了解直接数据采集系统工具如何确保数据采集的准确性、可读性、个人数据隐私的保护、及对直接数据采集系统工具的要求
    Understand how to ensure the data integrity, legibility, data privacy protection, and the requirements of DDC tools, through EMEA corresponding regulation and successful case study
  3. 解读《患者报告结局在临床研发中应用的指导原则(试行)》指南,了解COA工具,学习以患者为中心的新药研发理念
    Gain patient focused drug development concepts by knowing more the guideline about “Application of Patient Report Outcomes in Clinical Research and Development (Trial)” and Clinical Outcome Assessment (COA) tools

目标受众| TARGETED AUDIENCE:

  • 制药企业研发决策管理人员
    Managerial staff in R&D department
  • 临床试验数据管理员
    Clinical trial data managers
  • 临床试验项目经理
    Clinical trial project managers
  • 临床监查员
    Clinical trial monitors
  • 临床试验质量保证和质量控制人员
    Clinical trial quality assurance and quality control professionals
  • 临床试验稽查员
    Clinical trial auditors
  • 临床研究专业人员
    Clinical development professionals
  • 临床注册专业人员
    Clinical regulatory affairs professionals
  • 研究者和研究协调员
    Clinical researchers and study coordinator

组委会 (按姓氏首字母顺序排列) | Program Committee (In alphabetical order by surname):

程书彦,SCDM中国指导委员会委员、勃林格殷格翰亚洲区数字试验负责人
Sean Cheng, SCDM China Steering Committee Member;Digital Trials Lead Asia, Boehringer Ingelheim

邓亚中,SCDM 中国指导委员会委员、北京信立达医药科技有限公司总经理
Yazhong Deng, SCDM China Steering Committee Member; General Manager, Beijing Trust Medical Consulting Co., Ltd.

黎婉珊,SCDM中国指导委员会委员,默沙东研发(中国)有限公司全球临床数据管理中心亚太区高级总监
Joyce Lai, SCDM China Steering Committee Member; Senior Regional Director, Clinical Data Management, Global Data Management & Standards, MSD R&D (China) Co., Ltd.

Anita ShenSCDM中国指导委员会主席、辉瑞全球生物统计和数据管理部,数据监测和管理中国负责人Anita Shen, SCDM China Steering Committee Chair; Head of China Data Monitoring & Management (CDM&M), Global Biometrics and Data Management, Pfizer

孙华龙,SCDM中国指导委员会委员、北京科林利康医学研究有限公司首席运营官、美达临床数据技术有限公司总经理
Hualong Sun, SCDM China Steering Committee Member; Chief Operational Officer, Clinical Service Center; General Manager of Meta Data Technology

田正隆,SCDM中国指导委员会委员、高博医疗集团临床研究中心副总裁,首席数据官
Zhenglong Tian, SCDM China Steering Committee Member;Vice President, Chief Data Officer, Clinical Research Center, GoBroad Healthcare Group

颜崇超,SCDM中国指导委员会委员、上海盛迪医药有限公司临床数据科学中心副总经理
Charles Yan, SCDM China Steering Committee Member; VP, Clinical Data Science Center, Shanghai Shengdi Medicine Co., Ltd.

张薇,SCDM中国指导委员会委员、葛兰素史克(上海)医药研发有限公司医学开发部数据管理部门负责人
Wei Zhang, SCDM China Steering Committee Member; Head of Data Management, GSK Shanghai R&D

张玥,SCDM中国指导委员会委员、上海复宏汉霖生物技术股份有限公司副总裁,临床数据中心负责人
Carrie Zhang, SCDM China Steering Committee Member; Head of Data Science Center, Global Product Development, Shanghai Henlius Biotech, Inc.

PROGRAM

会前培训和研讨 | Preconference Workshops

7月7日 星期四 | July 7, 2022 Thursday
时间平行会场一
Parallel Session 1
平行会场二
Parallel Session 2

平行会场三
Parallel Session 3
09:00 - 12:00研讨会 A: 还在用Excel做dashboard吗?专家教你如何轻松实现临床数据管理可视化
Track A: Expert teach you how to realize visualization in Clinical Data Management

专题主持:黎婉珊,默沙东研发(中国)有限公司
Chair: Joyce Lai, MSD R&D (China) Co., Ltd.
Track B: 技术赋能人才转型:手把手教你掌握高效率Data Review技巧(初阶)
Track B: Technology empowers people transformation: Hands on Training on Cross Check/Listing (Level 1)

专题主持:
Anita Shen,辉瑞(中国)研究开发有限公司
程书彦,勃林格殷格翰(中国)投资有限公司

Co-chair:
Anita Shen, Pfizer (China) Research and Development Co., Ltd.
Sean Cheng, Boehringer Ingelheim
Track C: 手把手教你掌握高效率Data Review技巧(进阶)
Track C: Technology empowers people transformation: Hands on Training on Cross Check/Listing (Level 2)

专题主持:
Anita Shen,辉瑞(中国)研究开发有限公司
程书彦,勃林格殷格翰(中国)投资有限公司

Co-chair:
Anita Shen, Pfizer (China) Research and Development Co., Ltd.
Sean Cheng, Boehringer Ingelheim
12:00 - 13:00午餐 Lunch
13:30 - 16:30研讨会A: CDISC临床数据采集标准(CDASH)介绍与建库自动化考量
Track A: Introduction of CDASH and its application in automated database setup

专题主持:
田正隆,高博医疗集团
魏志军,诺华制药

大会日程 | Conference Agenda Day 1

6月18日 星期五 | Friday, June 18
时间 Time主题 Topic
08:30 - 08:40致欢迎辞
Welcome Speech
08:40 - 10:10
主旨演讲环节
Keynote Session
专题主席:Anita Shen,辉瑞(中国)研究开发有限公司
Chair: Anita Shen, Pfizer (China) Research and Development Co., Ltd.
10:10 - 10:25茶歇 | Coffee Break
10:25 - 11:55直接数据采集技术和合规性探讨
E2E Data Collection Technology and Compliance
专题主席:孙华龙,美达临床数据技术有限公司
Chair: Hualong Sun, Meta Data Technology
11:55 - 13:00午餐 | Lunch
13:00 - 15:00临床结局评估的开发标准和应用
COA Design and Application
专题主席:田正隆,高博医疗集团
Chair: Zhenglong Tian, GoBroad Healthcare Group
15:00 - 15:15茶歇 | Coffee Break
15:15 - 17:15标准库的应用
Application of Standard Library
专题主席:黎婉珊, 默沙东研发(中国)有限公司
Chair: Joyce Lai, MSD R&D (China) Co., Ltd

大会日程 | Conference Agenda Day 2

6月19日 星期六 | Saturday, June 19
时间主题
08:30 - 10:00利用信息化技术,提升数据管理工作的效率与质量
Information Technology to Enhance Data Management Efficiency & Quality
专题主席:颜崇超,上海盛迪医药有限公司
Chair: Charles Yan, Shanghai Shengdi Medicine Co., Ltd.
10:00 - 10:15茶歇 | Coffee Break
10:15 - 11:45利用信息化技术,提升数据管理工作的效率与质量
Information Technology to Enhance Data Management Efficiency & Quality
专题主席:颜崇超,上海盛迪医药有限公司
Chair: Charles Yan, Shanghai Shengdi Medicine Co., Ltd.
11:45 - 13:00午餐 | Lunch
13:00 - 14:30合成对照组和远程临床试验的数据及数据管理
Data and Data Management in Synthetic Control Arm and Decentralized Clinical Trial
专题主席:张玥,上海复宏汉霖生物技术股份有限公司
邓亚中,北京信立达医药科技有限公司

Chair: Carrie Zhang, Shanghai Henlius Biotech, Inc.
Yazhong Deng, Beijing Trust Medical Consulting Co., Ltd.
14:30 - 14:45茶歇 | Coffee Break
14:45 - 16:15数字化时代DM专业能力进阶
Advancing DM Expertise in Digital Era
专题主持:Anita Shen,辉瑞(中国)研究开发有限公司
程书彦,勃林格殷格翰(中国)投资有限公司

Co-chair: Anita Shen, Pfizer (China) Research and Development Co., Ltd.
Sean Cheng, Boehringer Ingelheim

注册费(人民币) | REGISTRATION FEE (CNY):

Early Bird Registration 早期注册优惠价

仅参加大会 Conference Only

¥2,600
SCDM会员
SCDM Members

¥2,800
非会员
Non-Members

会前培训及研讨A Preconference Workshop Track A

¥1,000
SCDM会员
SCDM Members

¥1,200
非会员
Non-Members

会前培训及研讨B(初阶)Preconference Workshop Track B (Level 1)

¥1,300
SCDM会员
SCDM Members

¥1,500
非会员
Non-Members

会前培训及研讨C (进阶)Preconference Workshop Track C (Level 2)

¥1,600
SCDM会员
SCDM Members

¥1,800
非会员
Non-Members

Standard Registration 标准注册价格

仅参加大会 Conference Only

¥2,900
SCDM会员
SCDM Members

¥3,100
非会员
Non-Members

会前培训及研讨A Preconference Workshop Track A

¥1,000
SCDM会员
SCDM Members

¥1,200
非会员
Non-Members

会前培训及研讨B(初阶)Preconference Workshop Track B (Level 1)

¥1,300
SCDM会员
SCDM Members

¥1,500
非会员
Non-Members

会前培训及研讨C (进阶)Preconference Workshop Track C (Level 2)

¥1,600
SCDM会员
SCDM Members

¥1,800
非会员
Non-Members

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