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Comparison of Emergency Use Pathways Among Japan-the US-Europe: Including Post-Marketing Management
Session Chair(s)
Nobumasa Nakashima
Professor
Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan
In addressing COVID-19, expedited product authorization was essential. Japan, the US and Europe have different pathways for emergency use authorization. We will introduce and compare the systems of each regulatory authority.
Learning Objective : (1) To deepen understanding of expedited authorization systems in Japan, the US, and Europe (2) To foster dialogue between participants and senior PMDA officials, senior FDA officials and senior EMA officials concerning drug/device regulatory concerns
Speaker(s)
Special Approval for Emergency in Japan
Junko Sato, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
EMA Perspective
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
FDA Perspective
Sandra Kweder, MD
ELIQUENT Life Sciences, United States
Principal, Drug and Biological Products