数字化转型推动临床数据管理

Drive CDM with Digital Transformation

在大数据时代背景下,新兴技术的发展和应用使得临床研究呈现出信息化、自动化、数字化和智能化的发展趋势,对临床数据管理工作流程和效率产生了影响的同时,也对临床数据管理人员需要掌握的专业知识和能力架构提出了新的要求。在临床数据管理向临床数据科学发展变迁的进程中,临床数据管理人员可把握这一重要时机,定义未来,重塑自身。
In big data era, the development and application of emerging technologies advance informatization, automization, digitization and Intelligentization in clinical research, which not only has a great impact on the work process and efficiency of clinical data management, but also requests CDM professionals to master new knowledge and skillset. As the clinical data management is now evolving to clinical data science, CDM professionals need to take this opportunity to define and reshape their future role.

第四届临床数据管理年度大会将于2021617-19中国上海举办,本届大会主题为“数字化转型推动临床数据管理”。届时受邀的国际国内行业专家们将围绕基于风险的数据审核、智能化数字技术在数据管理工作中的探索、数字化智能化时代数据管理员的定位及成长路径,新法规下的临床试验数据递交、新药国际递交的法规要求和核查要点等多个热点议题,探讨技术变革和法规要求变化等层面带来的挑战、机遇和应对策略。
Clinical Data Management 2021 China Conference will be held in Shanghai, China from June 17 to 19, 2021, themed “Drive CDM with Digital Transformation” . The invited international and domestic experts will discuss about challenges, opportunities and corresponding tactics brought by the changes of new regulations and technology innovation. Hot topics cover risk-based data review, the exploration of intelligent digital technology in data management, the positioning and growth path of data manager in digital times, clinical trial data submission under new regulation, regulation and inspection focus of Chinese new drugs going international, etc.

本届大会还将在6月17日开展会前培训和研讨,包含DM项目管理、电子临床数据(从采集到注册提交)以及高效数据核查三个专题,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。
Two parallel tracks of pre-conference workshops will be arranged on June 17. Topics include DM project management, electronic clinical data (from collection to registration and submission) and efficient data review. Instructors with hands-on experience will give lectures and facilitate the study and help CDM professionals skill up.

会议亮点 | CONFERENCE HIGHLIGHTS

– 明确新技术对临床数据管理的影响,增加临床数据管理人员对专业能力要求变化的认识,洞悉临床数据科学的发展前景
Explain the impact of new technology on clinical data management, increase the awareness of the knowledge and skill changes in CDM,  share insights on the prospect of clinical data science

– 了解新法规对于数据递交的要求,帮助新兴药企增加对国际法规要求的理解和自身核查要点
Understand the requirements of the new regulations for data submission, and help emerging domestic pharmaceutical companies better understand the data submission requirements of international regulations and self-inspection focus

– 临床数据管理训练营提供来自实际工作的案例解析,专家现场答疑解惑,手把手教学,小组互动,干货满满
Clinical data management bootcamp provides lectures and case studies ; expert panel help to clarify your questions; hands-on teaching enabling CDM master the knowledge and skill efficiently.

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
  • 临床试验项目管理员 | Clinical trial project administrators
  • 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

PROGRAM

6月17日 星期四 | Thursday, June 17 - Preconference Workshops
时间主题
09:00 - 12:00Track A: 临床数据管理的项目管理
Track A: How to manage a data management project
专题主持:张蕴,上海康德弘翼医学临床研究有限公司
Chair: Sally Zhang,WuXi Clinical Development Services Co., Ltd.
13:30 - 17:15Track A: 电子临床数据:从采集到注册提交
Track A: Electronic clinical data:from capture to submission
专题主持:颜崇超,上海盛迪医药有限公司
Chair: Charles Yan,Shanghai Shengdi Medicine Co., Ltd.
08:30 - 17:00Track B: 技术赋能人才转型:手把手教你8小时掌握高效率Data 数据核查技巧
Track B: Technology empowers people transformation:
Hands-on Training on Cross Check/Listing in 8 hours

专题主持:程书彦,勃林格殷格翰(中国)投资有限公司
Chair: Sean Cheng,Boehringer Ingelheim (China) Investment Co., Ltd.
6月18日 星期五 | Friday, June 18
时间主题
08:30 - 08:40>致欢迎辞
Welcome Speech
08:40 - 10:30主旨演讲:基于风险的数据审核
Keynote: Risk Based Data Review
专题主席:Anita She,辉瑞(中国)研究开发有限公司
Chair: Anita Shen,Pfizer (China) Research and Development Co., Ltd.
10:30 - 10:45茶歇 | Coffee Break
10:45 - 12:15智能化数字技术在临床数据管理中的探索
Exploration of Intelligent Digital Technology in Clinical Data Management
专题主席:韩亚丽,辉瑞(中国)研究开发有限公司
Chair: Han Yali, Pfizer (China) Research and Development Co., Ltd.
12:15 - 13:30午餐 | Lunch
13:30 - 15:00卡位!数字化临床试验时代
Positioning CDM in Digital Clinical Trials Era
专题主席:程书彦,勃林格殷格翰 (中国)投资有限公司
Chair: Sean Cheng, Boehringer Ingelheim (China) Investment Co., Ltd.
15:00 - 15:15茶歇 | Coffee Break
15:15 - 16:45外部电子数据有效管理
Effective Management of External Data
专题主席:张薇,葛兰素史克(上海)医药研发有限公司
Chair: Wei Zhang, GSK Shanghai R&D
6月19日 星期六 | Saturday, June 19
时间主题
08:30 - 10:00新法规下的临床试验数据递交
Clinical Trial Data Submission under the new regulation
专题主席:邓亚中,北京信立达医药科技有限公司
Chair: Yazhong Deng, Beijing Trust Medical Consulting Co., Ltd.
10:00 - 10:15茶歇 | Coffee Break
10:15 - 11:45中国新药走向国际的法规关注和核查应对
Regulation and Inspection Focus of Chinese New Drug Going International
专题主席:张玥,上海复宏汉霖生物技术股份有限公司
Chair: Carrie Zhang, Shanghai Henlius Biotech, Inc.
12:00 - 13:00午餐 | Lunch
13:00 - 14:30真实世界的数据应用
Utilization of Real World Data
专题主席:田正隆,高博医疗集团
Chair: Zhenglong Tian, GoBroad Healthcare Group
14:30 - 14:50茶歇 | Coffee Break
14:50 - 16:20数据化时代下的质量与指标管理
Quality and metrics management under digitalized world
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.

组委会 | PROGRAM COMMITTEE

  • 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总监
    Joyce Lai, SCDM China Steering Committee Member; Regional Director, Clinical Data Management, Global Data Management & Standards, MSD R&D (China) Co., Ltd.
  • 刘川,SCDM中国指导委员会副主席、北京科林利康医学研究有限公司首席科学官
    Daniel Liu, SCDM China Steering Committee Vice Chair; CSO, Beijing Clinical Service Center
  • Anita Shen,SCDM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
  • 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全球产品开发部数据科学中心总经理
    Carrie Zhang, SCDM China Steering Committee Member; Head of Data Science Center, Global Product Development, Shanghai Henlius Biotech, Inc.

注册费 | REGISTRATION FEE

早期注册优惠价(付款日期截止至4月30日)| Early Bird Registration (Payment Deadline April 30)

Conference Only 仅参加大会

¥2,300
SCDM Members
SCDM会员

¥2,500
Non-Members
非会员

Training Track A Only 仅参加会前培训Track A

¥900
SCDM Members
SCDM会员

¥1,000
Non-Members
非会员

Training Track B Only 仅参加会前培训Track B

¥1,300
SCDM Members
SCDM会员

¥1,500
Non-Members
非会员

Conference + Track A

¥3,200
SCDM Members
SCDM会员

¥3,500
Non-Members
非会员

Conference + Track B

¥3,600
SCDM Members
SCDM会员

¥4,000
Non-Members
非会员

标准注册价格 (5月1日-6月11日) | Standard Registration (May 1 to June 11)

Conference Only 仅参加大会

¥2,600
SCDM Members
SCDM会员

¥2,800
Non-Members
非会员

Training Track A Only 仅参加会前培训Track A

¥900
SCDM Members
SCDM会员

¥1,000
Non-Members
非会员

Training Track B Only 仅参加会前培训Track B

¥1,300
SCDM Members
SCDM会员

¥1,500
Non-Members
非会员

Conference + Track A

¥3,500
SCDM Members
SCDM会员

¥3,800
Non-Members
非会员

Conference + Track B

¥3,900
SCDM Members
SCDM会员

¥4,300
Non-Members
非会员

感谢临床数据管理2021年度大会赞助商的支持:

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