春和景明，我们于3月21日在阿斯利康北京、上海办公室及线上迎来了CQAF 2024第一季度的会议。此次会议是CQAF首次围绕GCP/GVP/GCLP的NMPA核查动态展开讨论，并分享相关案例。同时，作为CQAF首次推出的质量求新板块，我们从细胞治疗临床供应链的流程和风险管理出发，探讨创新领域的质量管理的策略和实践。此次会议约有30多名会员积极参加了线下研讨，170名CQAF会员从线上拨入。对于来自四面八方的同仁，这既是一个以行业内热点，痛点为出发点延伸至根本的学习交流的机会，更是一场许久未遇的老朋友们间的欢聚。 ...

The CQAF 2023 Q4 meeting, was held online on 22nd December. This is the first time to discuss the medical device (MD) regulation, audit, inspection and relevant safety reporting in the quarterly meeting. Around 130 CQAF members joined the meeting. Based on the pre-survey results by members, Ms. Athena Luo from Abbvie and Ms. Conny Mo from Pving shared their understanding and insights to the relevant regulation and safety reporting. At last, Sally Zhang along with CQAF Core Team and Advisory Group summarized the CQAF achievements of 2023, recent updates and the prospects of 2024. ...

The CQAF 2023 Q3 meeting, was held in the Shanghai office of BI and the Beijing office of Bayer on 21st September, as well as open online to members. More than 170 CQAF members joined the meeting online and around 30 members had interaction and discussion with the core team on site. The conference started with the announcement of CQAF organization updates and key progress. Then Sean Xu, Amy Jiang, and Dr. Yifeng Shen walked the audience through the “Overview of CAPA process and relevant cases discussion”, based on the pre-survey results and real cases provided by the members. ...

The CQAF 2023 annual meeting, the first onsite meeting after the pandemic, was held in the Shanghai office of MSD on 20 Jun. Around 80 CQAF members from global and local pharmaceutical companies and CROs joined this conference. The GCP and GLP experts and speakers walked the audiences through the three hot topics of “The revisions and changes of E6R3”,“Key points of inspection and common issues – inspection readiness of lab and the solutions to the common issues”and “The QA’s insight and consideration to the clinical trial common issues based on the key points of inspection”, based on the real cases and the pre-defined questionnaire results. ...

To deepen our members’ understanding of the pharmacovigilance quality management system in Good Pharmacovigilance Practice and Pharmacovigilance Inspection Guidelines, CQAF PV sub-committee hosted the 2nd Pharmacovigilance On-line Classes from late November to early December 2022, totally 4 sections. On the class, the PV and QA experts were invited to share PV quality management from 12 aspects. ...

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