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OS06 Challenge of Incorporating Patient Perspective in Drug Development: Lessons Learned from “System of Patient Engagement inRregulatory Review” by US Food and Drug Administration/European Medicines Agency
Session Chair(s)
Junko Sato, PhD
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Nanae Tanemura, PhD
Department of Food Function and Labeling·Head of section
National Institutes of Biomedical Innovation, Health and Nutrition, Japan
Speaker(s)
Junko Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Kyoko Asai, DVM, PhD
Hypersomnia & Long Sleeper Support Organization in Japan, Japan
Representative Director & CEO
Yukiko Nishimura, PhD, MSc
Advocacy Service for Rare and Intractable Diseases, Japan
Director
Juan Garcia-Burgos, MD, PhD
European Medicines Agency, Netherlands
Head of Public and Stakeholders Engagement Department
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER