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Session 4 - ICH Guideline Q5A-E, Q6B Training
Session Chair(s)
Tomonori Nakagawa
Production HQ Manufacturing Process Development Department (API), Otsuka Pharmaceutical Co., Ltd., Japan
Speaker(s)
Yasuhisa Ideno
Reviewer, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Q5A-E: Quality of Biotechnologycal/biological Products
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