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    RFI

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    药物警戒系统

    在SciencePharma,药物警戒系统外包是一个广泛的概念,涵盖了我们专家为客户在药物警戒领域执行的许多行动。如果您的公司在波兰或其他欧盟国家,甚至在欧盟以外的地区有授权产品或计划授权产品,您有法律义务为您的药品建立和维护药物警戒系统。根据贵公司的具体需求,我们的合作可以涵盖最适合您的活动范围。

    我们的服务包括但不限于:

    • 开发和维护药物警戒系统主文件(PSMF)及上市许可持有者的药物警戒标准操作程序(SOP);
    • 药物警戒系统的实施,包括准备安全数据交换协议(SDEA)——我们在这方面与法律部门合作;
    • 第57条(xEVMPD)基础管理——上市许可持有者负责适当维护xEVMPD中的信息,并在出现变更、转让或新授权时更新数据库。幸运的是,我们可以帮助您完成该过程。我们协助多家公司上传数据并更新xEVMPD数据库;
    • 风险管理计划(RMP)的开发和维护;
    • 药物警戒监管情报。

    我们的专家可以与您合作,协助药物警戒系统的所有元素,或仅处理其中的个别部分——我们也可以根据您的期望定制服务。

     

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      请注意,在上述表格中输入的个人数据的管理员是SciencePharma Sp. z o.o. 注册办事处位于Warsaw, Chełmska 30/34. 处理这些数据是为了接收收到的信件并对其作出回应。提供个人数据是自愿的,但对于发送表格是必要的。每个人都有权访问他们的数据并对其进行更正。

      您可以查看有关个人数据保护的详细信息点击这里.