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[SESSION 5] Real World Data and Database Research
Session Chair(s)
Yukiko Nagata
Director, Biometrics
ICON Clinical Research GK, Japan
Hitoshi Ozawa, MPharm
GCP Inspector, Office of Non-Clininical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Current utilization of real-world data has focused on clinical development and post-marketing surveillance, or pharmacovigilance. A new medical information database system for pharmacovigilance – MID-NET – is being established for full-scale operation by the Pharmaceuticals and Medical Devices Agency, which will also amend its Good Post-marketing Study Practice (GPSP) to incorporate use of this new medical information database. In addition, the Ministry of Health, Labour and Welfare published its Basic Principle for Utilization of Medical Information Database in Post-Marketing Pharmacovigilance in June 2017. What can data managers contribute in the midst of such evolution and renovation, and how can they contribute it? This session will discuss the future utilization of this medical information database from various stakeholder perspectives.
Speaker(s)
Current Situation of Database Research
Tomomi Kimura, MD
Astellas Pharma Inc., Japan
Director, Epidemiology, Medical Affairs
Outline of Revised GPSP - Consideration on “Points to Consider for Ensuring the Data Reliability on Post-Marketing Database Study for Drugs”
Hiroyuki Mizuta, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspector, Office of Non-Clinical and Clinical Compliance
Process to Ensure Reliability for Post-Marketing Database Study Based on Experience of Inspection with PMDA
Hiroyuki Kakihata
Chugai Pharmaceutical Co., Ltd., Japan
Real World Data Science Department
Usability of Real World Data and its Usage Issues - Collaboration between Data Scientist and Data Manager -
Takamichi Baba, MSc
Shionogi & Co., Ltd., Japan
Data Scientist
Yuichi Yamada
Shionogi & Co., Ltd., Japan
Data Manager, Biostatistics Department
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