CQAF 2021 1Q Meeting will be held on 26 Mar. (13:30-16:00) . Considering the possible continuation of the epidemic, the conference will continue to be held online; starts with the topic regarding the ‘Technical Guidelines for Image Evaluation Procedures in Clinical Trials of Antitumor Drugs’ issued by CDE on 14Jan2021, aiming to combing the logic behind the relevant technical requirements or industry standards in the overall design, implementation and data management of image evaluation and discuss the key points of the imaging laboratory audit. Sponsor representative, investigator site’s radiologist, investigator and QA of independent central imaging reading laboratory are invited to join this section. In the meanwhile, we will also discuss the ownership of clinical trials data upon ‘The Consensus on Ownership of Clinical Data’ issued by Shanghai Pharmaceutical Association. Core members from CQAF would also bring the analysis of 2020 survey feedbacks. You will have chance to talk with the quality experts in the above areas. Please do register the meeting soon! ...

Insurance in drug clinical trials has been a hot topic in the industry. The GCP stipulates that The sponsor should provide the investigator/institution legal and economic insurance or guarantees related to the trial that are proportionate to the nature and degree of risk of trial. CQAF will invite clinical trial insurance experts in the industry to walk us through “Clinical Trials Liability Insurance”，meanwhile CQAF chairperson Cathy Liu will announce the new CQAF core team. We look forward to your registration! We look forward to your registration! ...

In the new "Drug Administration Law" in 2019, establishing a pharmacovigilance system is required for the first time in China. The second paragraph of its Article 12 stipulates: "The state should establish a pharmacovigilance system to monitor, identify, evaluate and control adverse drug reactions and other adverse drug-related reactions." ...

2020, we are ten years old! CQAF Annual Meeting will be held on 18Sep (9:00-16:30) at MSD Shanghai and Beijing Office (Tentative). The experiences sharing and discussion will focus on “Remote Audit and Inspection” & “Create and adopt agile & fit-for-purpose quality strategies for different types of organizations, in order to maximize your business values”. We will also take this opportunity to look back on the 10 years we have gone together and celebrate our 10th birthday. Please do register the meeting soon! ...

This is the first time that CQAF opens its meeting to public: Impact of China 2020 GCP on the conduct of clinical trials from Quality Management perspective. 这是CQAF首次对公众开放分享会，从质量管理的角度洞悉新版中国GCP对临床试验的影响。 ...

CQAF 2020 年第一季度会将于3月20日（13:00-16:00）召开。由于近期疫情，这次会议将采取线上拨入形式，围绕近期国内疫情下的业务连续性计划等热点话题展开，包括：供申办方访问的脱敏电子病例（Desensitized EMR available for sponsor access）和直接面向患者的供应（ Direct-to-Patient Supply）。CQAF的核心成员还会就远程原始数据查阅、直接面向患者的供应、伦理考量和知情等热点话题为会员们带来他们多年的见解和经验并解答会员们的疑问。 参会会员将有机会和他们进行探讨交流。赶紧来注册啊！ ...