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[V5-S6] Risk-based Approachto Monitoring — Part 2: Implementation Status of TransCelerate Member Companies in Japan
Session Chair(s)
Naoyuki Yasuda, MSc
Associate Executive Director , Office of International Programs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yuji Fukuda
Manager, PMS Management
Eli Lilly Japan K.K., Japan
Speaker(s)
RBM Challenges Focused on Study PreparationStage in Asian Study
Yosuke Kubota
Astellas Pharma Inc., Japan
Manager, Global Project Management
Risk Based MonitoringCase of GlaxoSmithKline
Masayuki Kanezaki
GlaxoSmithKline K.K., Japan
Manager, Clinical Operations Department
Risk-Based Monitoring in BMS
Yumi Ichimoto
Bristol-Myers Squibb K.K., Japan
Regulatory Strategy Manager, Global Regulatory Sciences Japan
Risk Based Monitoring Methodology
Junichi Hamada
Nippon Boehringer Ingelheim Co., Ltd., Japan
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