2017 SCDM-BBA China Event

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2017 SCDM-BBA China Event
International Clinical Data Management and Electronic Platform in Clinical Trial
国际水平临床试验数据管理与电子数据平台
December 10-11, 2017 Beijing | Shanghai

Background:
With China join ICH and a series of CFDA regulations released regarding clinical trial data management and international trial data utility in CFDA NDA submission, China pharmaceutical industry is drown into attention for international level high quality trial data dramatically. NDA submissions to both CFDA and FDA become R&D development strategy in many top pharma in China. Understanding international clinical data management requirement, standard and best practice is in great need in China industry.
继国家食品药品监督管理总局发布了一系列关于临床试验数据管理法规后,中国加入了ICH并允许采用国际临床试验数据进行国内申报,很多制药企业把国际国内双递交作为研发战略,对国际水平高质量临床试验数据的关注大幅度提高。理解国际水平临床试验数据管理标准、要求和最佳实践是实现这一目标的关键和必经之路。
The Society for Clinical Data Management (SCDM) is a non-profit, international organization of 2,200+ members, created to advance the discipline of Clinical Data Management. The Good Clinical Data Management Practices (GCDMP©) standard is a reference to international clinical data managers in high quality Clinical Data Management processes. GCDMP is used as a reference in CFDA new released clinical data management guidance.
和DIA相似,SCDM(临床数据管理学会)是专注于临床试验数据管理、引领学科不断进步的国际非盈利组织,在全球拥有 2200 多名会员。《临床数据质量管理规范》(GCDMP©) 为临床数据经理们实施高质量的临床数据管理流程提供了参考标准。CFDA于2016年7月29日发布的临床数据管理指导原则中也参考了GCDMP©的内容。
This event is organized and prepared by SCDM China committee and will be presented by clinical data experts with in-depth knowledge and years of hand-on experience in clinical data management. The content discussing in the event are from international clinical data management professionals, which will provide us with most recent updates of global practice.
国际水平临床试验数据管理与电子数据平台论坛将于2017年12月10-11日在北京和上海同时举办。本次论坛由SCDM(临床数据管理学会)和北京生物医学统计与数据管理研究会共同举办,邀请具有多年国际临床试验数据管理经验的国际国内专家分享全球数据管理的概况,探讨国际水平数据管理的技术要求、要点,采用实战演练的方式与参会者共同讨论学习。

Targeted Audience (目标参会人员):
–  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

SCDM China Education Committee 中国教育委员会:

– Yazhong Deng,
Beijing Trust Medical Consulting Co. Ltd
邓亚中,北京信立达医药科技有限公司
– Daniel Liu, Beijing Clinical Service Center
刘川,北京科林利康医学研究有限公司
– Anita Shen, Janssen of Johnson & Johnson
沈彤,杨森(中国)研发中心
-Charles Yan, Hengrui Medicine Co., Ltd
颜崇超,江苏恒瑞医药股份有限公司
-Carrie Zhang,
eClinWise,, Panacea Technology Co., Ltd
张玥,博纳西亚临智(上海)数据科技有限责任公司

Registration报名费用:

SCDM Member (SCDM会员): RMB1,200元;

Non-members(非会员): RMB1,600元 (First 100 registrants will get one-year SCDM membership,valued USD80, 前一百名报名并付款者将获赠SCDM一年会籍,价值80美金)。
For Group Registrants, please contact SCDM China Event Hotline below.

关于团体报名优惠请拨打咨询热线。

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

 Special thanks to sponsors’ contribution

感谢以下赞助商对本次活动的大力支持

Live broadcast of this event is supported by ( 感谢金玉良研对本次活动直播的支持)