6th DIA China Annual Meeting

In the past years, there are some new regulations and guidance published in the world, such as US FDA risk-based monitoring guidance, e-source guidance, EMA TMF guidance, CFDA clinical data management guidance etc. This session will give an overview of these new regulations and guidance related to the data monitoring and quality management of clinical studies. By these presentations and discussion, the audience may have further understanding of the global standard status and trends as well as differences on the data quality and integrity of clinical studies. Moreover, US FDA and EMA updated regulations and guidance related to the data management of clinical studies as well as CFDA guidance and expectations on data quality management will be overviewed.