2021年5月13日，国家药监局正式发布了《药物警戒质量管理规范》(以下简称“规范”)。该管理规范是新版《药品管理法》落地之后的首个药物警戒配套文件，首次从法规层面明确了药物警戒质量管理的要求，强调质量管理对于提升药物警戒体系运行效能，和确保药物警戒活动持续符合相关法律法规要求的重要意义。 ...

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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