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RWE Design and Case Study
Session Chair(s)
Shanmei LIAO
Senior Director, Post Approval Stat Lead
Beigene, China
For recent years, Real world evidence remains as one of the hottest topics in the health care related community, industry and academia. Start from the 21st Century Cures Act by FDA, to recent working guidance on using RWD for registration from NMPA, and the various wearable, tractable devices linked with numerous data companies generating reports, the whole world seems to be ready to embrace the merits of the “new-born”. However, with no surprise, solid cases are still rare, especially when we come to the area of registration and post market evaluation. Luckily, we have gathered four experienced experts in this area, who have successful cases on different aspects of the RWD application. You will hear them sharing their stories about using RWD for registration in new indication expansion and rare diseases, evaluating vaccine products based on RWD and innovative methods in RWS design and RWD analyses.
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