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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
Associate Center Director - CDER, FDA, United States
Case Examples and Thoughts on Accelerated Approval Pathways
President, Pfizer R&D Japan, Japan
PRIME, Collaboration, and Evidence by Design
Head of Division International Affairs, European Medicines Agency, Netherlands
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