问答

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

For other varieties that regulatory agencies require attention to, signal detection frequency should be increased. What are the types of products that regulatory authorities require to pay attention to, and is it the same definition as the evaluation conclusion of the PSUR report submitted to regulatory authorities, which is' concerned/not concerned '?
2023-09-27 09:59:13
What detection or calculation method is more scientific for signal detection when the data pool used for signal detection is small?
2023-09-27 09:58:55
按照药品管理的体外诊断试剂，是否必须开展信号检测分析评价以及上市后安全性研究工作，如必须开展，从什么角度着手比较合理？

2023-09-27 09:58:34
How can generic drug manufacturers do a good job in identifying signal detection and risk control?
2023-09-27 09:58:12
What are the practical operability of PV risk control measures, especially special risk control measures?
2023-09-27 09:57:51
风险管理计划需要药品安全委员会审核吗？

2023-09-27 09:57:29

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