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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)
Theresa Mullin, PhD
Associate Center Director - CDER, FDA, United States
FDA Recent Experience and Perspective on the Accelerated Approval Pathway
Taro Ishibashi, PhD, RPh
President, Pfizer R&D Japan, Japan
Case Examples and Thoughts on Accelerated Approval Pathways
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
PRIME, Collaboration, and Evidence by Design
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