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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The Q3 meeting for CQAF members was held virtually in the afternoon of 27 Sep 2022. Speakers from Bayer and Roche pharma companies presented two topics of “Together with Patients” and “Patient Centricity Clinical Study of Rare Diseases”, walked the audience through the practice of the patient group engagement across the clinical trials and the relevant opportunities and challenges, such as patient recruitment, retention, education etc.. Then the founder of Chinese Organization for Rare Disorders (CORD) brought the topic “Leverage Patient Org to Promote the Drug R&D” and shared the insights from rare disease patient perspective. The two-hour meeting was closed in a panel discussion joined by CQAF core team members. ...