SESSION-5

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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