RFI

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    A man holding a blister pack of tablets, while a woman examines the product leaflet. The scene reflects a focus on pharmacovigilance, emphasizing the monitoring of medicine safety and adherence to Good Pharmacovigilance Practices (GVP). The individuals are engaged in ensuring the proper management of adverse effects and compliance with EU requirements.

    药物警戒服务- Pharmacovigilance services

    药物警戒(PV)是监测药品安全性的过程。上市许可持有人(MAHs)有法律义务建立和维护药物警戒系统。我们的团队具备与不良反应的检测、评估、理解和预防相关的适当知识和经验。SciencePharma已根据良好药物警戒规范(GVP)制定了完整的药物警戒系统,符合欧盟要求,因此我们提供完整的药物警戒服务。我们为客户提供实施我们的药物警戒系统的服务,包括系统的所有质量方面。

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    来自不同来源的病例报告分析与管理

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    PSURs(定期安全更新报告)准备

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    风险管理计划准备

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    制药公司不良事件(AEs)监测

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