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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)
Satomi Yagi
Reviewer, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
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