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. ...

The Q2 meeting for CQAF members was held virtually in the afternoon of 22 June 2022. Speakers from Huashan Hospital and MNC pharma companies presented two topics of “How we interpret the test reports under the mutual recognition of test results” and “the Clinical Laboratory Audit” respectively. ...

CQAF 1st quarter meeting of 2022 was held on 28 March, a total of 260 members attended on line due to COVID-19 prevention policy. Topics discussed and shared during the meeting were “Managing Protocol Deviations” and “Effective Internal audit” .The speakers came from MNC pharma, and China local pharma as well as bio-tech company. It was a very interactive session where different stakeholders shared their experience on PD management and sponsor internal audit. ...