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Session 1: Background and Philosophy of Each Region BE Guideline
Session Chair(s)
Rumiko Shimazawa, PHD
Professor, School of Medicine
Tokai University School of Medicine, Japan
Background and Philosophy of Each Region BE Guideline
Speaker(s)
Basic Stance of Japanese BE Guidelines
Chikako Yomota
National Institute of Health Sciences, Japan
Invited Researcher
Evolving FDA's Bioequivalence Standards
Lawrence Yu, PHD
FDA, United States
Director, Office of New Drug Products, OPQ, CDER
Bioequivalence: Towards Global Harmonization?
Susana Almeida
Inflamax Research Inc., Portugal
Senior Director of European Operations
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