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Session 5 - ICH Guideline Q12 Training
Session Chair(s)
Tomonori Nakagawa
Production HQ Manufacturing Process Development Department (API)
Otsuka Pharmaceutical Co., Ltd., Japan
Speaker(s)
Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Satomi Yagi
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug III
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