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Session 0708: CMC REQUIREMENTS FOR THERAPEUTIC BIOLOGICAL PRODUCT AT DIFFERENT CLINICAL DEVELOPMENT STAGE (PART II)
Speaker(s)
Process Evaluation / Validation from Phase I to Phase III
Armin Klein
F. HoffmannLa Roche Ltd., Switzerland, China
Technical Regulatory Lead
The Manufacture and Quality Control of the Drug Investigated in Clinical Trial
Xinyan LI
Zesun (Shanghai) Science & Technology Co., Ltd., China
Executive Vice President
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