CQAF 2023 Quarterly Meeting will be held on September 21 (13:30-15:50) in the Conference Room of BI Shanghai Office and Bayer Beijing Office.  At this quarterly meeting, we will first announce the change of CQAF core team and the progress of CQAF collaborative and major projects. Then we will discuss the important quality topic of CAPA. CAPA (Corrective Action & Preventive Action) is a commonly used quality management tool in clinical trials. However, in practice, there are misunderstandings about CAPA understanding and use. For example: Is CAPA required after all issues occur? What kind of issues require CAPA initiation? How to dig out the root causes of issues? How to develop CAPA? How to effectively implement CAPA to avoid of the recurrence of issues? We will discuss around CAPA in the 3rd quarter CQAF meeting. Look forward to your participation!  ...

CQAF 2023 Annual Meeting will be held in the conference room in MSD Shanghai at 9:00-16:00 on Jun. 20. Please be noted that there will be NO on-line sessions, except for the session ‘Key Points and Determination Principles of Drug Registration Inspection and common issues (Laboratory)’, held on 11:00-12:00am) . Other topics such as ‘The revisions and changes of E6R3, and the considerations to the future quality related work" and “The QA’s insight and consideration to the clinical trial common issues based on the Key Points and Determination Principles of Drug Registration Inspection’ will be discussed. We are looking forward to your participation!  ...

...

为帮助我国临床试验稽查人员了解稽查的组织实施及稽查要点，提高稽查技巧，推动临床试验稽查工作的有效开展，从而促进我国药物临床试验进一步规范化，国家食品药品监督管理总局高级研修学院将在北京举办临床试验稽查培训班。...