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ON DEMAND - Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA
Session Chair(s)
Nobumasa Nakashima
Professor
Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 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)
FDA Recent Experience and Perspective on the Accelerated Approval Pathway
Theresa Mullin, PHD
FDA, United States
Associate Center Director - CDER
Case Examples and Thoughts on Accelerated Approval Pathways
Taro Ishibashi, PHD, RPH
Pfizer R&D Japan, Japan
President
PRIME, Collaboration, and Evidence by Design
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs