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Raffles City Convention Centre

Jan 28, 2013 7:00 AM - Jan 30, 2013 5:00 PM

252 , North Bridge Road, Singapore 179103, Singapore

Asia Regulatory Conference 2013

Session 3: Asia's Role in Drug Development: A Global and Regional Perspective

Session Chair(s)

Romi  Singh, PHD

Romi Singh, PHD

Professor of Practice, Regulatory Sciences, Northeastern University, United States

Tomas  Salmonson, DrMed, PHD

Tomas Salmonson, DrMed, PHD

, Critical Path Institute, Netherlands

Historically, drug registrations in Asia followed, and to a large extent depended on, the Western drug development. However, over the recent years, there has been an increasing trend of Asia becoming a hub of global drug innovation and development. This session will discuss how Asia contributes to the global drug development and provide examples of how data generated primarily in Asia is used for registration in the West (US, EU).

Speaker(s)

Yoshimasa  Shimoto, PHD

Yoshimasa Shimoto, PHD

Vice President, Asia Development (Region Head), Daiichi Sankyo Co., Ltd., Japan

Contribution of Asia in Execution of Global Clinical Trials

Tomas  Salmonson, DrMed, PHD

Tomas Salmonson, DrMed, PHD

, Critical Path Institute, Netherlands

Asia's Role in Drug Development - an European Perspective

Raymond S.B. Chua, MD, MBA, MPH, FRCP

Raymond S.B. Chua, MD, MBA, MPH, FRCP

Deputy Director of Medical Services, Health Regulation Group , Ministry of Health, Singapore

Concept of Adaptive Licensing and Its Feasibility for a New Pathway of Drug Development from the Regional and Global Regulators' Perspective

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