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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

Recent Trends in Asian Regulations for Drug Development: What is Coming Next?

Session Chair(s)

Akio  Uemura, PhD

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)

Chao-Yi  Wang, MSc

Successful Regional Collaborative Experience in Global New Drug Development: TFDA Perspective

Chao-Yi Wang, MSc

TFDA, Taiwan

Senior Researcher

Fengyun (Vicky)  Han

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

Yoshiaki  Uyama, PhD, RPh

The Latest Japanese RegulatorySituations to Promote Drug Development and Advance Regulatory Science

Yoshiaki Uyama, PhD, RPh

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director

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