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Session 5 : Riding the wave of GCP renovation -Transformation of Quality Management (Risk Based Approach)
Session Chair(s)
Hiromi Nihei
Data Management & Central Monitoring, Johnson & Johnson, Japan
Megumi Kitayama
Specialist, Prime Research Institute For Medical RWD, Inc., Japan
Speaker(s)
Risk-based Data Management Initiatives : Insights from chatting events ofDIA CDM Community
Yoko Hattori
Clinical Research Center, Data Management, Chiba University Hospital, Japan
RBDM in Practice in Clinical Trials: Overcoming Challenges, Embedding Core Values
Shinji Moriwaki
Data Management & Central Monitoring, Johnson & Johnson, Japan
Risk-based Data Management in Post-Market Surveillance (PMS) -withFit-for-purpose in Mind -
Natsuno Yamashita
Clinical Data & Information Sciences, Pfizer R&D Japan, Japan
QMS/RBA from the Perspective of Clinical Data management in Academia:An Example and Challenges
Miyuki Ishiguro
Clinical Research, Innovation and Education Center, Tohoku University Hospital, Japan
Natsumi Kinoshita
Inspection Director, Office of Non-clinical and Clinical Compliance II, Pharmaceuticals and Medical Devices Agency, Japan
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