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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)
Q5A-E: Quality of Biotechnologycal/biological Products
Yasuhisa Ideno
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug IV