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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA

Session Chair(s)

Nobumasa  Nakashima

Nobumasa Nakashima

Health Policy Director, National Healthcare Policy Secretariat

Cabinet Office, Japan

Surprise- Enjoy this session from DIA Europe 2020

This session invites key stakeholders including industry representatives and regulators to actively share the current situation and concerns of early access programs. And subsequently, means to better these programs are discussed.

Speaker(s)

Theresa  Mullin, PhD

FDA Recent Experience and Perspective on the Accelerated Approval Pathway

Theresa Mullin, PhD

FDA, United States

Associate Center Director - Strategic Initiatives, CDER

Taro  Ishibashi, PhD, RPh

Case Examples and Thoughts on Accelerated Approval Pathways

Taro Ishibashi, PhD, RPh

Pfizer R&D Japan, Japan

President

Agnès  Saint-Raymond, DrMed

PRIME, Collaboration, and Evidence by Design

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

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