In the recent years, China regulatory makes efforts to reform the review process for drug registration and issues a series of guidelines. The statistical review plays an increasing important role in the whole review process. Globally, evidence-based data-driven principles are bringing the drug development and regulatory communities together in the effort to bring innovative drugs to patients early.

The 2017 DIA China Quantitative Science Forum (QSF), with the theme of “Data Science in regulatory Decision Making”, will build a platform for quantitative scientists from regulatory, academia, global and local industry, and opens a window for other clinical trial participants, including clinical scientist, industry regulatory staff, etc, to have a deep understanding of statistical guidelines. In the forum, the experts from regulatory (CFDA, US FDA, PMDA), pharmaceutical industry, and academia, including those from China Clinical Trial Statistics (CCTS) and Clinical Data Management working group of China (CDMC), will discuss current hot topics with the participants. These will include the statistical considerations in drug consistency assessment, multi-regional clinical trials, biosimilar evaluation, real world study, etc. It will promote the communication between the quantitative scientists from global and local companies, and illustrate how quantitative science help shorten time and save costs in drug development.