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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)
Real-World Evidence and Next Generation Regulatory Decision Making
Nancy A Dreyer, PhD, MPH, FISPE
Dreyer Strategies LLC, United States
Founder
Application of Medical Big Data to Clinical Trial Simulation
Akiyuki Suzuki, MS
Pfizer Japan Inc., Japan
Senior Manager, Pharmacometrics Group, Clinical Pharmacology
Application Case-Outcomes Research using Real World Data -
Shinzo Hiroi, PhD, MPH, RPh, PMP
Shionogi & Co., Ltd., Japan
Head of Global Medical Affairs