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Session 8C: Regional Updates – Part 2: Asia-Pacific
Session Chair(s)
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 numerous new and innovative regulatory developments coming to light in the Asia-Pacific region. In order to have a successful clinical trial application and/or MAA submission in this region, sponsors need to be made aware of these changes and requirements and how to adapt. This session will cover the latest hot topics in the Asia-Pacific region including Japan, China, and many other countries, regarding the regulatory submissions. A closing panel discussion and Q&A will allow for more in-depth discussions on these topics.
Speaker(s)
Xiling Song, MS
Senior Quality Product Leader, Genentech, A Member of the Roche Group, United States
Session Co-Chair
Issei Takayama, DRSC
Reviewer, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Japan
Regulatory Updates and Hot Topics - Japan
Yang (Frank) Gao
Associate Regulatory Affairs Director, Eli Lilly and Company, China
Regulatory Updates and Hot Topics - China
Xiling Song, MS
Senior Quality Product Leader, Genentech, A Member of the Roche Group, United States
Regulatory Updates and Hot Topics – Other Asia-Pacific Countries
Chi-Wan Chen, PHD
, Pfizer, Inc., United States
Panelists Joining the Session Speakers
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