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[V1-S2] Vision for the Future: Global Simultaneous Approval — Efforts and Challenge for Simultaneous Review on Each Country
Session Chair(s)
Fumiaki Kobayashi, PhD
President
CTD inc., Japan
Speaker(s)
Comparison of the queries during a simultaneous review by PMDA/FDA/CHMP
Kazumi Sunamura
Pfizer R&D Japan, Japan
Director, Regulatory Strategy & Policy 2
Experience of Global Simultaneous Submission and Challenges
Chitose Nishida
GlaxoSmithKline K.K., Japan
Department Manager of Regulatory Excellence
Considering Point and Future Networking with Foreign Regulatory Authorities in Global Simultaneous Review
Toyotaka Iguchi, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of Safety II
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