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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

Special Session-1 : Orphan Drug Development Update - Issues and Measures for Global Cooperation –

Session Chair(s)

Kenichi  Tamiya, MSc, RPh

Kenichi Tamiya, MSc, RPh

Associate Executive Director, Office of New Drug

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Speaker(s)

Christine  Nguyen, DrMed

Orphan Drug Development Update: Issues and Measures for Global Cooperation

Christine Nguyen, DrMed

U.S. Food and Drug Administration(FDA), United States

Deputy Office Director, Office of Rare Diseases, Pediatrics, Urologic and Reprod

Sandra  Retzky, DO, JD, MPH

Sandra Retzky, DO, JD, MPH

U.S. Food and Drug Administration(FDA) , United States

Director, Office of Orphan Product Development, Office of the Commissioner

Kristina  Larsson, MS

European Orphan Medicines Regulations

Kristina Larsson, MS

European Medicines Agency, Netherlands

Head of Orphan Medicines, Division for Human Medicines Evidence Generation

Koshin  Kiyohara

Koshin Kiyohara

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Director, Office of Review Management

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