MID-NET Among PMDA’s First Steps Into RWE

Dr. Yoshiaki Uyama, Director of the Office of Medical Informatics & Epidemiology for the Pharmaceuticals and Medical Devices Agency (PMDA), Japan, and DIA Global Forum Regulatory Science co-editor, shares his vision for utilizing real world evidence in regulatory science. “The challenge is, we still don’t understand completely the characteristics and the limitations of those data. We are very familiar with assessing or evaluating the data of a clinical trial. But real world data is not completely of the same character as that of a clinical trial because those real world data are not primarily collected for such purposes.”