Shinichi Okudaira
PMDA-Pharmaceuticals and Medical Devices Agency
Dr. Shinichi Okudaira is currently Deputy Review Director in Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA). He is involved in the review of CMC of biologics. In 2009, he graduated and received a Ph.D. in Pharmaceutical Sciences from Graduate School of Pharmaceutical Sciences, the University of Tokyo. He was previously a researcher and associate professor of Department of Molecular and Cellular Biochemistry, Graduate School of Pharmaceutical Sciences, Tohoku University (2009-2013). In 2013, he joined PMDA as Reviewer in Office of New Drug V (Oncology drugs).
Appearances
DateDecember 7, 2020Speakers
F. Hoffmann-La Roche Ltd.PMDA-Pharmaceuticals and Medical Devices AgencyPMDA-Pharmaceuticals and Medical Devices AgencyEuropean Medicines Agency (EMACDER, FDASession Chairs
PMDA-Pharmaceuticals and Medical Devices AgencyGenentech, a Member of the Roche GroupPanelists
PMDA-Pharmaceuticals and Medical Devices AgencyDaiichi Sankyo Co., Ltd.
DateDecember 7, 2020Speakers
F. Hoffmann-La Roche Ltd.PMDA-Pharmaceuticals and Medical Devices AgencyPMDA-Pharmaceuticals and Medical Devices AgencyEuropean Medicines Agency (EMACDER, FDASession Chairs
PMDA-Pharmaceuticals and Medical Devices AgencyGenentech, a Member of the Roche GroupPanelists
PMDA-Pharmaceuticals and Medical Devices AgencyDaiichi Sankyo Co., Ltd.
DateDecember 6, 2021Speakers
Global Biotech Experts, LLCPMDA-Pharmaceuticals and Medical Devices AgencyPMDA-Pharmaceuticals and Medical Devices AgencyCBER, FDACDER, FDAHealth CanadaSession Chairs
Genentech, a Member of the Roche GroupPMDA-Pharmaceuticals and Medical Devices AgencyPanel Member
PMDA-Pharmaceuticals and Medical Devices Agency
DateDecember 7, 2021Continuous Manufacturing (CM) of biologics has been a hot topic for recent years because it has a potential for improving the efficiency, agility, and flexibility of drug substance and drug product manufacturing…Session Chairs
BioMarin Pharmaceutical Inc.PMDA-Pharmaceuticals and Medical Devices AgencySpeakers
PMDA-Pharmaceuticals and Medical Devices AgencyPMDA-Pharmaceuticals and Medical Devices AgencySanofiPanel Members
Merck & Co., Inc.Novo Nordisk Inc.Chugai Pharmaceutical Co., Ltd.
DateDecember 6, 2021Speakers
Global Biotech Experts, LLCPMDA-Pharmaceuticals and Medical Devices AgencyPMDA-Pharmaceuticals and Medical Devices AgencyCBER, FDACDER, FDAHealth CanadaSession Chairs
Genentech, a Member of the Roche GroupPMDA-Pharmaceuticals and Medical Devices AgencyPanel Member
PMDA-Pharmaceuticals and Medical Devices Agency
DateDecember 7, 2021Continuous Manufacturing (CM) of biologics has been a hot topic for recent years because it has a potential for improving the efficiency, agility, and flexibility of drug substance and drug product manufacturing…Session Chairs
BioMarin Pharmaceutical Inc.PMDA-Pharmaceuticals and Medical Devices AgencySpeakers
PMDA-Pharmaceuticals and Medical Devices AgencyPMDA-Pharmaceuticals and Medical Devices AgencySanofiPanel Members
Merck & Co., Inc.Novo Nordisk Inc.Chugai Pharmaceutical Co., Ltd.
