Our first CQAF Quarterly Meeting for Y2020 is indeed a unique event to remember as for the first time we break our tradition of meeting face to face in Beijing and Shanghai; and go with an all-virtual meeting to maintain social distancing and do our part to reduce/prevent the spread of Coronavirus (COVID-19) outbreak in the community. ...

Focusing COVID-19, a summary of guides issued by MHRA, EMA and FDA. ...

新冠疫情下的临床试验建议_来自MHRA ...

6 updates from active regulatory Agencies, hot topics covering Adaptive design clinical trial, Remote Decentralized clinical trial, Signal Management System, RWE/RWD, Data integrity, even Novel Coronavirus. Read following for details. ...

The last batch of Regulatory Express in 2019, along with warm wishes for 2020. Happy New Year. ...

CQAF 2019 年第四季度会于12月17日下午在上海津石医药科技有限公司北京和上海会议室召开。来自约60家医药公司、临床试验机构和合同研究机构的88名成员参加了面对面会议或网络会议。本次会议由陈华女士主持，交流了质量管理领域的最新热点问题，包括：中国药物警戒法规的变化和检查的经验分享，以及近期药物临床试验机构质量管理研讨班的讨论内容。 ...