Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Alberto Grignolo, PhD
- Corporate Vice President
- Parexel, United States
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National Academy of Sciences, on the first Executive Committee of the Clinical Trials Transformation Initiative, as Chairman of the Regulatory Affairs Professional Society, and as President of FIDIA Pharmaceutical Corporation. He is a DIA Fellow, Editor-in-Chief of DIA's digital magazine Global Forum, and serves on the faculty of DIA's Regulatory Affairs: The IND, NDA, and Post-Marketing training course, which he has taught in Japan, China, Korea, Europe, and the US.
Yoshiaki Uyama, PhD, RPh
- Director, Office of Medical Informatics and Epidemiology
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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-).