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S09 : FDA and PMDA Update: Oncology Drug Development and Regulation
Session Chair(s)
Shinichi Okudaira
Division Director Division of International Cooperation, Pharmaceuticals and Medicals Devices Agency (PMDA), Japan
R. Angelo De Claro, MD
Deputy Director (Acting), Oncology Center of Excellence, FDA, United States
Speaker(s)
R. Angelo De Claro, MD
Deputy Director (Acting), Oncology Center of Excellence, FDA, United States
Masakazu Hirata, MD, PHD
Clinical Reviewer, Division of RS Consultation, Kansai Branch, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulatory Framework for Facilitating Development of Oncology Drugs in Japan
Richard Pazdur, MD
Director, Oncology Center of Excellence, CDER, FDA, United States
Hiroshi Yaginuma
Director, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoko Aoi, PHD
Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dianne Spillman
Associate Director, Global and Regulatory Outreach, OCE, FDA, United States
Kristina Larsson, MS
Head of Orphan Medicines, Division for Human Medicines Evidence Generation, European Medicines Agency, Netherlands
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