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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根据我国新修订的《药品管理法》，药品上市许可持有人对药品研制、生产、经营、使用全过程中的药品的安全性、有效性和质量可控性承担全面的责任。基于药物警戒活动对患者安全和对公众健康的重要性，药品监管部门需要定期或不定期地组织药物警戒检查，以确定上市许可持有人药物警戒职责履职合规的情况，帮助持有人提升药物警戒工作水平和能力。 ...