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[V7-S4] More Advanced Approach of Medical Big Data - Part 1
Session Chair(s)
Hisashi Urushihara, DrPH
Professor, Faculty of Pharmacy, Department of Pharmacy, Keio University, Japan
Yuji Yamamoto, MD, MBA
Founder and CEO, MinaCare Co., Ltd., Japan
Medical big data have become indispensable in medicine development. Many people have been making decision by reference to information come from big data analysis. In this session, we will comprehensively review the advanced approach for big data utilization and future perspective with pioneering experts from Global as well as Japan. We will share advanced examples of clinical trial design and operations including randomized pragmatic trials, outcomes research and post-marketing safety assessments. The potential impact of GCP renovation will also be discussed.
Speaker(s)
Nancy Dreyer, MPH, FISPE
Founder, Dreyer Strategies LLC, United States
Real-World Evidence and Next Generation Regulatory Decision Making
Akiyuki Suzuki, MS
Senior Manager, Pharmacometrics Group, Clinical Pharmacology, Pfizer Japan Inc., Japan
Application of Medical Big Data to Clinical Trial Simulation
Shinzo Hiroi, PHD, MPH, RPH, PMP
Senior Director, Project Management, IDC ICO Real World Solutions, ICON Clinical Research GK, Japan
Application Case-Outcomes Research using Real World Data -