New CFDA Requirements and its Implementation
New CFDA Requirements and its
Implementation
Yi Yang, Senior Principal Programmer Sep 4, 2018 PharmaSUG Single Day Event Tokyo, Japan
Disclaimer
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All information provided in this slides is provided for information purposes only
Views expressed in this presentation are those of the speaker and not necessarily of Novartis
Global Drug Development
Biography
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Yi (Eason) Yang joined Novartis in 2010 and is currently Senior Principal Programmer
Global Drug Development
CFDA or CNDA
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2013.03 ? 2018.03
China Food and Drug Administration
2018.03 ? Present
China National Drug Administration
Global Drug Development
Agenda
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CNDA Reform New Guidance & Guidelines EntrestoTM CNDA Submission Case Study
Summary
Global Drug Development
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