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Tuesday, June 20 • 10:30am - 11:45am
#214: Recent Trends in Asian Regulations for Drug Development: What is Coming Next?

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Akio Uemura, PhD

Speaker

Successful Regional Collaborative Experience in Global New Drug Development: TFDA Perspective
Chao-Yi Joyce Wang, MSc

RecentTrend in Drug Development Regulations of China and Other Asian Countries
Vicky (Fengyun) Han, Esq

The Latest Japanese RegulatorySituations to Promote Drug Development and Advance Regulatory Science
Yoshiaki Uyama, PhD


Moderators
avatar for Akio Uemura

Akio Uemura

Executive Director, Head of Japan Development, Allergan Japan K.K.
1996: Head of biosciences lab, Mochida Pharmaceutical, 2000: Director, project management, EL Japan, 2004: Clinical phase global project manager, Eli Lilly, 2007: Director, regulatory policy, liaison and intelligence, EL Japan. 2011: Head of Japan Regulatory Affairs, Allergan Japan... Read More →

Speakers
avatar for Vicky (Fengyun) Han

Vicky (Fengyun) Han

Senior Director, Asia Pacific Regulatory Policy Group Lead, Asia Pacific, Johnson & Johnson Pte. Ltd.
Vicky Han is Senior Director at Janssen Pharmaceuticals in charge of Asia Pacific Regulatory Policy since 2016. Her experiences spans in Asia & Europe, she dedicated 18 years in GSK, wherein 12 years in GSK China for leading regulatory affairs. In 2008, she moved to Belgium for dealing... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for all epidemiological activities in PMDA including the projects of MIHARI(Medical Information for risk assessment... Read More →
avatar for Chao-Yi Wang

Chao-Yi Wang

Director, Division of Medicinal Products, Ministry of Health and Welfare, TFDA, Chinese Taipei
Ms. Chao-Yi (Joyce) Wang was appointed as the Director of Division of Medicinal Products, TFDA, Chinese Taipei, Ministry of Health and Welfare on January 7, 2016. She is responsible for management of pharmaceutical policies and regulations, including premarket approval of medicinal... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Session