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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
Invited Researcher, National Institute of Health Sciences, Japan
Evolving FDA's Bioequivalence Standards
Lawrence Yu, PhD
Director, Office of New Drug Products, OPQ, CDER, FDA , United States
Bioequivalence: Towards Global Harmonization?
Susana Almeida
Senior Director of European Operations, Inflamax Research Inc., Portugal
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