Clinical Data Management 2018 China Conference

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临床数据管理(主设计图)

临床数据管理2018年度大会
Clinical Data Management 2018 China Conference
June 10-12, Shanghai |6月10-12日 上海
优化临床数据管理,助力中国新药研发
Optimize Clinical Data Management, Support China New Drug Development

会议背景Background:

近年来国家推出一系列新药审评改革政策和对临床试验数据质量、数据管理 与统计分析的法律法规,鼓励创新,为促进中国新药研发和上市提供了有力的支持和保障。中国新药不仅在国内加快了研发和上市步伐,也同时走向国际,进行国际递交和注册,让中国新药迈出国门, 为全球人类的健康做出贡献。数据质量是临床试验成败的重要基石,了解中国和国外新药审评对临床试验数据的要求,对成功完成新药的国际国内上市至关重要。

临床数据管理学会(SCDM)和北京北京生物医学统计与数据管理研究会 (BBA)将  在中国举办为期两天的“优化临床数据管理,助力中国新药研发”的交流会议,邀请国内外监管和临床数据管理专家分享中国和美国新药申报的法规要求,探讨临床数据管理团队建设经验,讨论国际电子数据(eSource)新进展。

In recent years, China has issued a series of reform policies on new drug review and regulations on clinical trial data quality, data management and statistical analysis, not only encouraging innovation, but also strongly supporting and promoting new drug development and approval in China. While accelerating the pace of new drug development and approvals in China, domestic pharmaceutical companies also turned their focus to international NDA approvals. China innovative drugs are going abroad contributing to the health of human being worldwide. Data quality is an important foundation of the success of clinical trials. Understanding the requirements on clinical trial data in China and other countries’ new drug review is crucial.

The Society for Clinical Data Management (SCDM) and Beijing Biometrics Association (BBA) will co-organize a two-day conference with theme of “Optimize clinical data management, Support China new drug development” in Shanghai, China. Domestic and international regulatory and clinical data management experts will share regulatory requirements for new drug applications and approvals in China and United States, discussing how to build an international quality clinical data management team, and recent progress in eSource, et al.

Submit your abstract!   Download the Abstract Guidelines here.

会议亮点 (Conference Highlights):

1-  国内外监管和国际数据业内专家分享国际国内递交临床试验数据法规要求及最新进展 Domestic and international regulatory and clinical data management experts to share requirements for clinical trial data in new drug application and approvals both in China and US, as well as most recent global process in data and data management.

2- 国外递交材料对临床数据的要求和稽查要点 Requirements on clinical data during international NDA submissions and inspection key points

3- 数据管理团队的建设和人才培训 Building Clinical Data Management Team and Professionals Training

4- 国际临床试验数据平台要求及国际电子数据(eSource)发展现状 EDC System Requirements for International Clinical Trials and Current eSource Progress Globally

 

目标参会人员 (Targeted Audience):

-Managerial staff in R&D department

制药企业研发决策管理人员

– Clinical trial data managers
临床试验数据管理员

–  Clinical trial project managers
临床试验项目经理

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

– Clinical trial monitors
临床监查员

-Clinical trial quality assurance and quality control professionals
临床试验质量保证和质量控制人员

-Clinical trial auditors
临床试验稽查员

-Clinical development professionals
临床研究专业人员

-Clinical regulatory affairs professionals
临床注册专业人员

-Clinical researchers and study coordinators
研究者和研究协调员

报名费用 (Registration):

 Registration Fee
注册费
 Conference Only
仅参加会议
 Training Only
仅参加会前培训
 Conference+ Training (Two sessions)
会议+会前培训(两个专题)
 SCDM Member
SCDM会员
 ¥2600  ¥500/session(单个专题)  ¥800/two sessions
(两个专题)
 ¥3280
 非会员  ¥3000  ¥600/session (单个专题)  ¥1000/two sessions
(两个专题)
 ¥3780

Please Click Registration or Scan the QR code to complete the registration form online.
请点击报名或扫描二维码在线报名。

SCDM China Event Hotline(咨询热线):
86-21-32798627,info-CN@scdm.org

Would you like to sponsor the SCDM 2018 China Conference? 赞助机会

赞助机会 – Sponsorship Brochure

会议组委会 (按姓氏首字母倒序排列) Organizing Committee:

  •  Zhang, Carrie, SCDM Board MembereClinWise,, Panacea Technology Co., Ltd  张玥,SCDM全球委员会委员 博纳西亚临智(上海)数据科技有限责任公司
  •  Yan, Charles, Hengrui Medicine Co., Ltd 颜崇超,江苏恒瑞医药股份有限公司
  • Sun, Hualong, Meta Clinical Technology 孙华龙,美达临床数据技术有限公司
  • Shen, Anita, member of SCDM China Steering Committee 沈彤,SCDM中国指导委员会委员
  • Fu, Haijun, Shanghai Zenith Medical Tech Co., Ltd 付海军,上海韧致医药科技有限公司
  • Deng, Yazhong, Beijing Trust Medical Consulting Co. Ltd 邓亚中,北京信立达医药科技有限公司