GCP培训在药品上市后安全性评价工作中的作用

Discussion on GCP Training Role in Drug Post-Marketing Safety Evaluation

我国药物临床试验的规范化是建立在法规完善的基础上,并通过大量的培训工作得以推广和落实。通过归纳分析国内药品上市后临床试验质量追踪中的问题,列举了GCP培训对药品上市后临床试验发挥的作用,阐述了药品上市后安全性研究面临的新挑战,以期为GCP培训提供新思路。

The standardization of drug clinical trials in China is not only based on laws and regulations, but also is carried out with a lot of training. The article analyzes the problems of the quality of clinical trials occurred in quality tracking of domestic post-marketing clinical trials, listed the role of GCP training on post-marketing drug clinical trials, and illustrated new challenges for post-marketing drug safety study in order to provide new ideas for GCP training.