SAE与药物之间的因果关系判断，一直是热议话题，尤其是当‘5分法’遇到‘2分法’，行业内存在不同的理解和操作方法，也是GCP检查的关注重点之一。究竟应该怎么理解这个问题，申办方如何满足SUSAR报告的要求，是否还需要考虑其他因素？ ...

2022年5月19-22日， DIA2022中国年会将起航于苏州国际博览中心，本次会议将以更加前瞻和务实的姿态聚焦监管政策创新、科学技术创新、以及人才创新三大核心挑战。 ...

CLQA (CQAF Sub-Committee) 2022 年第一季度会将于3月26日（9:00-11:00）召开。考虑到可能的疫情延续，这次会议将继续采取线上拨入形式。会议的议程如下，参会会员将有机会和他们进行探讨交流。期待您的参与！ ...

CQAF 2022 1Q Meeting will be held on Mar. 28 (13:30-16:45) concurrently at the conference room of AZ in Beijing, Shanghai and On-line. The conference will focus on the hot topics which our CQAF members are much interested in, that include Managing Protocol Deviation, Effective sponsor Internal Audit and the CQAF Update. Look forward to your participation! ...

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! ...