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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
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Kyoko Asai, DVM, PhD
Representative Director & CEO, Hypersomnia & Long Sleeper Support Organization in Japan, Japan
Yukiko Nishimura, PhD, MSc
Director, Advocacy Service for Rare and Intractable Diseases, Japan
Juan Garcia-Burgos, MD, PhD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Theresa Mullin, PhD
Associate Center Director - CDER, FDA, United States