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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)
Session Co-Chair
Xiling Song, MS
Genentech, A Member of the Roche Group, United States
Senior Quality Product Leader
Regulatory Updates and Hot Topics - Japan
Issei Takayama, DRSC
Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Japan
Reviewer, Office of New Drug IV
Regulatory Updates and Hot Topics - China
Yang (Frank) Gao
Eli Lilly and Company, China
Associate Regulatory Affairs Director
Regulatory Updates and Hot Topics – Other Asia-Pacific Countries
Xiling Song, MS
Genentech, A Member of the Roche Group, United States
Senior Quality Product Leader
Panelists Joining the Session Speakers
Chi-Wan Chen, PHD
Pfizer, Inc., United States