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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)
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
U.S. Food and Drug Administration(FDA) , United States
Director, Office of Orphan Product Development, Office of the Commissioner
European Orphan Medicines Regulations
Kristina Larsson, MS
European Medicines Agency, Netherlands
Head of Orphan Medicines, Division for Human Medicines Evidence Generation
Koshin Kiyohara
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of Review Management