返回 Agenda
Recent Trends in Asian Regulations for Drug Development: What is Coming Next?
Session Chair(s)
Akio Uemura, PHD
Senior Advisor
AU Consulting, Co., Japan
Needless to say, Asia is one of the most important and emerging regions in the world and its significance in global drug development is increasing. This session is aiming to give an update on the recent regulatory trends in East Asian countries. Regulatory agencies from major East Asian countries including Japan, Singapore, and Taiwan, together with the industry representation, will give an overview of the recent regulatory environment changes in each country. We will also hear about their effort to promote harmonization of regulations for drug development in this region and discuss actual examples of Asian drug development utilizing multiregional clinical trials in Asian countries.
Learning Objective : Discuss the most updated regulations for drug development in each Asian country; Discuss how Asia is contributing to worldwide drug development; Describe activities in the Asian region with respect to modernization and harmonization of regulations.
Speaker(s)
Successful Regional Collaborative Experience in Global New Drug Development: TFDA Perspective
Chao-Yi Wang, MSC
TFDA, Taiwan
Senior Researcher
RecentTrend in Drug Development Regulations of China and Other Asian Countries
Fengyun (Vicky) Han
Johnson & Johnson Pte. Ltd., Singapore
Senior Director, Head of Regulatory Policy for Asia Pacific
The Latest Japanese RegulatorySituations to Promote Drug Development and Advance Regulatory Science
Yoshiaki Uyama, PHD, MS, RPH
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director