问答

Statement: The content of this Q&A reflects the current views of CQAF, for mutual learning and exchange among industry colleagues.

药物警戒部门经理必须配备吗？

2023-10-18 18:06:25
企业必须配备药物警戒专职人员吗？如果企业只有单一品种，已指定药物警戒负责人，并委托第三方进行药物警戒工作，这种情况下，企业的药物警戒专职人员是否是必须配备的？

2023-10-18 18:05:27
ArrayShould the PV office be consistent with the registered address of the enterprise? Is it possible to work in another location
2023-10-18 18:05:04
Is it feasible to combine signal assessment and risk assessment
2023-09-27 10:00:10
仿制药产品说明书不良反应描述内容相对概括性较高，明确列出的不良反应症状较少，而在收集的报告中大部分是以临床具体描述的症状作为不良反应名称，按新的定义界定说明书没有明确载明的属于新的不良反应；请问，企业在进行产品分析时面对此类的不良反应应如何处置，是否需要提出修订说明书，应该怎么界定在达到什么样的标准后修订说明书？

2023-09-27 09:59:52
The adverse reactions in the instructions for traditional Chinese medicine after its launch are not yet clear, and no individual cases have been collected through all channels. What is the basis for modifying the content of adverse reactions in the instructions?
2023-09-27 09:59:32

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