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Special Session-1 : Orphan Drug Development Update - Issues and Measures for Global Cooperation –
Session Chair(s)
Kenichi Tamiya, MSC, RPH
Associate Executive Director, Office of New Drug, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Christine Nguyen, DrMed
Deputy Office Director, Office of Rare Diseases, Pediatrics, Urologic and Reprod, U.S. Food and Drug Administration(FDA), United States
Orphan Drug Development Update: Issues and Measures for Global Cooperation
Sandra Retzky, DO, JD, MPH
Director, Office of Orphan Product Development, Office of the Commissioner, U.S. Food and Drug Administration(FDA) , United States
Kristina Larsson, MS
Head of Orphan Medicines, Division for Human Medicines Evidence Generation, European Medicines Agency, Netherlands
European Orphan Medicines Regulations
Koshin Kiyohara
Director, Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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