DIA EUROPE 2021

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Comparison of Emergency Use Pathways Among Japan-the US-Europe: Including Post-Marketing Management

Session Chair(s)

Nobumasa Nakashima

Health Policy Director, National Healthcare Policy Secretariat

Cabinet Office, 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

Greenleaf Health/Elilquent, United States

Principal, Drug and Biological Products

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