Navigating the New Era of Reform and Revitalization: Japan

With an improved clinical trial infrastructure now a high priority, Japan offers an advantageous development environment for pharmaceutical, biotechnology, and medical device companies. To address a decade-long downward trend in trial applications and a lag in the availability of drugs within the country as compared to other developed nations, Japan's Ministry of Health, Labor and Welfare (MHLW) has ushered in significant changes in recent years. These include bold steps to create a more welcoming and efficient approach to trials while maintaining global standards such as those of the International Conference on Harmonization/ Good Clinical Practice (ICH-GCP).

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Clinical Trials in China: A Double Standard?

As increasing numbers of clinical trials take place in China – the site of numerous, well-publicized quality issues in the pharmaceutical manufacturing business – it is time to ask: Are there any differences in the quality standards of local vs. global trials conducted in China? What might be the reasons for any apparent differences? And, finally, should both types of studies be held to the same standards?

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ICON Profile

Joyce H. Lee - Director Clinical Operations, ICON Clinical Research

I joined ICON in May 2010 to head up the Clinical Operations in China and lead the group of clinical-trial professionals based in Shanghai, Beijing, and Hong Kong. I am responsible for ensuring the optimal management of resourcing to meet the best interests of our clients. In addition to supervising daily operational activities, I am also involved in a wide range of business development initiatives and provide strategic inputs to support planning in terms of long-term business expansion.

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Did you know?

ICON has almost 900 employees in 14 Asia Pacific countries – China, Japan, Korea, Hong Kong, Taiwan, India, Indonesia, Malaysia, Philippines, Singapore, Thailand, and Vietnam, Australia, and New Zealand.

The first Asia Pacific office opened in Tokyo, Japan, in 1996 and now has over 100 staff with further expansion planned.

ICON Central Laboratories supports the Asia Pacific region from facilities strategically located in the region. The ICON laboratories in Singapore and India are wholly-owned, CAP accredited and NGSP Level I certified and utilise the same testing platforms and operate to the same high quality standards as all ICON laboratories globally.

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