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A worker diligently fills out pharmacovigilance documentation, ensuring compliance with the EMA's Guideline on Good Pharmacovigilance Practices (GVP Module IV). This scene highlights the importance of risk-based audits for Marketing Authorisation Holders (MAH) to maintain a robust pharmacovigilance system.

药物警戒-PhV

2012年7月关于药物警戒的立法规定了上市许可持有人（MAH）对其药物警戒（PhV）系统进行定期风险审计的法律要求。欧洲药品管理局（EMA）的《良好药物警戒实践指南》（GVP模块IV）中包含了关于规划和进行法律要求的审计的指导。拥有足够资格和经验丰富的审计师，SciencePharma提供基于风险的审计服务，对MAH药物警戒系统提供独立、客观的意见。

See more <- dodać linkowanie do strony chińskiej GVP audits remote and on site

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