| 欧盟药品不良反应管理和上报指南简介 |
| |
| 引用本文： | 董铎,刘巍,杨乐,刘翠丽,程刚.欧盟药品不良反应管理和上报指南简介[J].中国药物警戒,2014(10):611-613. |
| |
| 作者姓名： | 董铎 刘巍 杨乐 刘翠丽 程刚 |
| |
| 作者单位： | 国家食品药品监督管理总局药品评价中心,北京100045 |
| |
| 摘 要： | 通过对于欧盟药品不良反应管理和上报指南的介绍，进一步了解欧盟对药品不良反应定义、报告收集、报告确认、报告随访、数据管理、质量管理等不良反应管理流程，为完善和发展我国药品不良反应报告和监测工作提供借鉴和参考。
|
| 关 键 词： | 欧盟 药物警戒 不良反应 管理 上报 |
Introduction of Management and Reporting of Adverse Reactions to Medicinal Products in European Union |
| |
| DONG Duo,LIU Wei,YANG Le,LIU Cui-li,CHENG Gang.Introduction of Management and Reporting of Adverse Reactions to Medicinal Products in European Union[J].Chinese JOurnal of Pharmacovigilance,2014(10):611-613. |
| |
| Authors: | DONG Duo LIU Wei YANG Le LIU Cui-li CHENG Gang |
| |
| Institution: | (Center For Drug Reevaluation, CFDA, Beijing 100045, China) |
| |
| Abstract: | By introducing good pharmacovigilance prctice on management and reporting of adverse reactions to medicinal products in EU, it was more cleared to know the definition of adverse reactions and working process in EU, such ascollection of reports, validation of reports, follow-up of reports, data management, quality management. It provided the example and refrence for perfecting and developing drug adverse reaction reporting and monitoring system in China. |
| |
| Keywords: | European Union pharmacovigilance adverse reactions management reporting |
| 本文献已被 维普 等数据库收录！ |
|
