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Ariake Central Tower Hall and Conference

2023年11月05日 (日) 午前 9:30 - 2023年11月07日 (火) 午後 6:00

Ariake Central Tower 3F, 4F, 3-7-18 Ariake, Koto-ku, Tokyo, 135-0063 Japan

20th DIA Japan Annual Meeting 2023

Rebuilding Drug Development through Society 5.0: The Fusion of Knowledge and Technology that Transcends Time and Space

S09 : FDA and PMDA Update: Oncology Drug Development and Regulation

Session Chair(s)

Shinichi  Okudaira

Shinichi Okudaira

Division Director Division of International Cooperation

Pharmaceuticals and Medicals Devices Agency (PMDA), Japan

R. Angelo  De Claro, MD

R. Angelo De Claro, MD

Associate Director for Global Clinical Sciences, Oncology Center of Excellence

FDA, United States

Speaker(s)

R. Angelo  De Claro, MD

R. Angelo De Claro, MD

FDA, United States

Associate Director for Global Clinical Sciences, Oncology Center of Excellence

Masakazu  Hirata, MD, PhD

Regulatory Framework for Facilitating Development of Oncology Drugs in Japan

Masakazu Hirata, MD, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Clinical Reviewer, Division of RS Consultation, Kansai Branch

Richard  Pazdur, MD

Richard Pazdur, MD

Food and Drug Administration (FDA), United States

Director, Oncology Center of Excellence, CDER

Hiroshi  Yaginuma

Hiroshi Yaginuma

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Director, Office of New Drug V

Yoko  Aoi, PhD

Yoko Aoi, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Deputy Review Director, Office of New Drug V

Dianne  Spillman

Dianne Spillman

U.S. Food and Drug Administration , United States

Associate Director, Global Regulatory Outreach, OCE

Kristina  Larsson, MS

Kristina Larsson, MS

European Medicines Agency, Netherlands

Head of Orphan Medicines, Division for Human Medicines Evidence Generation

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