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在明媚的阳光中,迎来2022年第一期Regulatory Express, 想和您分享以下话题,欢迎点击正文链接,查看详情。 ...
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CQAF 1st quarter meeting of 2022 was held on 28 March, a total of 260 members attended on line due to COVID-19 prevention policy. Topics discussed and shared during the meeting were “Managing Protocol Deviations” and “Effective Internal audit” .The speakers came from MNC pharma, and China local pharma as well as bio-tech company. It was a very interactive session where different stakeholders shared their experience on PD management and sponsor internal audit. ...
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近年来,国家药品监管部门为管理和指导药物警戒工作相继出台了一系列法规。对于委托管理,《药物警戒质量管理规范》第二章第三节第十五条明确规定“持有人是药物警戒的责任主体,根据工作需要委托开展药物警戒相关工作的,相应法律责任由持有人承担”。本文从质量管理的角度出发,梳理持有人在委托管理各环节需考虑的要点,旨在为委托管理提供思路和启发。 ...
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关于CQAF网站数据异常通告 ...
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持续评估风险和获益:临床试验中重要信息的更新 ...
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Here we’d like to release highlights on topic of Paediatric Clinical Trials, updated Q&A from EMA and MHRA, GCP Inspection Metrics Report. ...