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Dynamic Changes in Regulatory Landscape in Asia: Regulations for Global Drug Development
Session Chair(s)
Akio Uemura, PhD
Senior Advisor
AU Consulting, Co., Japan
The regulatory environment in Asia is rapidly changing and its importance for global drug development is rising high. We will hear from an Asian regulatory agency and industry and discuss how we should actively modify our development strategy based on recent changes.
Learning Objective : Discuss recent changes in drug development regulations in Asian countries; Identify regulations related to different phases of drug development; Describe how industry and regulatory agencies collaborate with each other for better and faster drug development by reviewing recent example of global drug development utilizing multiregional clinical trials including Asia.
Speaker(s)
New Regulations for Drug Development in Japan
Yoshiaki Uyama, PhD, MS, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Recent Status of Regulation and Clinical Trial in Korea
Sang Ki Kim, MD
Ministry of Food and Drug Safety (MFDS) , Korea, Republic of
Deputy Director, Clinical Trials Management Div, Pharmaceutical Safety Bureau
Regulatory Challenges in China Drug Development
Qing Shen, MS
Shanghai Roche Pharmaceutical Ltd., China
Senior Principle Technical Advisor
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