
Good pharmacovigilance practices (GVP) - European Medicines Agency (EMA)
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.
Pharmacovigilance - European Medicines Agency (EMA)
The European Medicines Agency developed the good-pharmacovigilance-practice (GVP) guideline to facilitate the performance of pharmacovigilance activities in the European Union. GVP is a key deliverable of the 2010 pharmacovigilance legislation to replace earlier guidance drawn up by the European Commission.
For the purpose of GVP, which provides guidance on structures and processes of a pharmacovigilance system, the quality of a pharmacovigilance system can be defined as all the characteristics of the system which are considered to produce, according to estimated likelihoods, outcomes relevant to the
欧盟更新药物警戒质量管理规范指南 - 知乎 - 知乎专栏
欧洲药品管理局(EMA)于 8 月 5 日发布了更新版的 药物警戒实践(Good Pharmacovigilance Practice,GVP)指南,引入关于风险最小化措施(Risk minimisation measure,RMM)的新信息和更新后的定义。
欧盟药物警戒法规简介 - 知乎 - 知乎专栏
同时为了更好地促进新的药物警戒法规的具体实施,欧盟药品管理局制定了新的《药物警戒实践指南》(Guideline on Good Pharmacovigilance Practices,GVP),作为欧盟药物警戒工作的新准则。
2017年12月12日 · This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.
GVP大家谈 | 中国和欧盟药物警戒管理规范对照--中国食品药品网
2021年5月25日 · 欧盟gvp是为促进在欧盟执行药物警戒活动而制定的一套措施,目前的模块部分包括16个模块,涵盖欧盟主要的药物警戒流程。 其适用对象是药品上市许可持有人、欧洲药品管理局(EMA)和欧盟成员国的药品监管机构。
GVP Updates - ECA Academy
2024年10月1日 · The European Medicines Agency (EMA) released the 3rd revision of Good Pharmacovigilance Practices (GVP) Module XVI on risk minimization measures. The date of coming into effect was 6 August 2024. The revised final guidance is applicable to. The document is not immediately applicable to existing RMMs and ongoing activities regarding RMMs.
欧盟药物警戒法规(Pharmacovigilance Legislation)简介 - 搜狐
2018年1月19日 · 同时为了更好地促进新的药物警戒法规的具体实施,欧盟药品管理局制定了新的《药物警戒实践指南》(Guideline on Good Pharmacovigilance Practices,GVP),作为欧盟药物警戒工作的新准则。
Good Pharmacovigilance Practice: EMA GVP Modules Guide
2023年3月30日 · In 2025, guaranteeing the secure and compelling utilize of medications remains vital, and following to great pharmacovigilance hones is significant. The European Medications Organization (EMA) has set up comprehensive rules to guarantee the secure observing of drugs all through their lifecycle.