Dr Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for all epidemiological activities in PMDA including the projects of MIHARI(Medical Information for risk assessment initiative) and MID-NET®(Medical Information Database Network). He has many experiences in regulatory science of benefit/risk assessment of a new drug, including the role in ICH as ICH Technical Coordinator (2004-2009), the topic leader of ICH E15 and E16, Rapporteur of ICH E17 Expert Working Group (2014-2017) and Rapporteur of ICH Pharmacoepidemiology Discussion Group (2019-2021).