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Washington Marriott Hotel

Apr 15, 2013 8:30 AM - Apr 17, 2013 12:00 PM

1221 22nd Street NW, , Washington, DC 20037-1294 , USA

CMC Workshop: From Drug Development to Global Supply to Patients

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Session 4C: Clinical Trials Submissions in Asia Pacific Region

Session Chair(s)

Lin-Jau (Christine) Wu Anderson, BSN, MSc, RAC

Lin-Jau (Christine) Wu Anderson, BSN, MSc, RAC

Senior Research Scientist, Global Regulatory, Chemistry, Manufacturing & Control

Eli Lilly and Company, US, United States

There are many new regulatory developments in the Asia Pacific region. In order to have a successful clinical trial application in this region, the sponsors need to stay on top of the changes and new requirements. This session will cover the most recent hot topics in China, South Korea, India, Taiwan, Hong Kong, Malaysia, etc., regarding the clinical trial submission.

Speaker(s)

Xiling Song, MS

Clinical Trial Application in Asia Pacific Region other than China

Xiling Song, MS

Genentech, A Member of the Roche Group, United States

Senior Quality Product Leader

Chi-Wan Chen, PhD

Clinical Trial Application in China

Chi-Wan Chen, PhD

Pfizer, Inc., United States

Key Regulatory Development in China

Min Gui, PhD

Bristol-Myers Squibb, United States

CMC Regional Expert Asia Pacific, Global Regulatory Sciences - CMC

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