文章

Regulatory Express_Q3 2019

Some Regulatory Authority perspective on EHR system、RBM Approaches、COA and so on. Also an interesting analysis of FDA and EMA New Drug Approval Metrics ...

2019-09-25 09:34:41
CQAF 2019 Q3 会议简讯

CQAF 2019年第三季度会议于9月2日下午在罗氏北京和上海办公室举行。来自约70家制药公司、临床试验机构和合同研究机构的103名成员参加了面对面会议或WebEx会议。本次会议由沈一峰博士主持，重点讨论了质量管理领域的最新热点问题：包括中心实验室/生物实验室工作流程概述和药物警戒体系的介绍和药物警戒分会的更新。 ...

2019-09-12 16:00:18
Share your Ideas and Experience in Quarterly Meeting

Based on the feedbacks we collected from you, and as well as the reflection of CQAF mission, we welcome you to join us to propose topics and act as a speaker to share your experience in future quarterly meeting. ...

2019-07-08 10:25:40
Regulatory Express_Q2 2019

5 topics are collected from FDA、MHRA、ICH and EMA, ranging from RWE、ICH guidline to RBM. ...

2019-06-24 11:36:14
Regulatory Express_Q1 2019

The 1st release of Regulatory Express in 2019 is ready. ...

2019-03-26 14:47:30
TransCelerate cQMS 中文翻译发表

自2018年2月开始，CQAF 被授权翻译TransCelerate 发表的关于cQMS 的文章，中文版陆续在国家药品监督管理局食品药品审核查验中心的双月刊【国际药品检查动态研究】上发表。随后应邀撰写了临床试验质量管理常见问题的分析一文，供业界同道参考。今年开始将会陆续发表TransCelerate RBM的中文版，敬请期待。 ...

2019-02-21 20:48:48

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