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Session 1 / Venue 6: Recommendations for Developing Postmarketing Surveys and Clinical Investigations Using SS-MIX Standardized Storage
Session Chair(s)
Kiyoshi Kubota, MD, PhD, FISPE
Director
Drug Safety Research Unit Japan, Japan
The Standardized Structured Medical record Information exchange (SS-MIX) was started in 2006 as the project supported by MHLW for promoting the exchange of the standardized medical information. Free software developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). Four academic societies and three pharma industry parties collaboratively worked to prepare the recommendations for developing postmarketing surveys and clinical investigations, and made available to the public in November 2012. The recommendations consisted of 7 parts; (1) information with high accuracy and granularity, (2) as the backup system, (3) the “new user” design, (4) fast and efficient data collection in surveys (5) evaluation of risk minimization action plan, (6) possible use cases in clinical trials, (7) as source data. In this session, working group members will provide presentations from many angles and audience would understand the possible use cases of SS-MIX standardized storage.
Speaker(s)
Medical Institutions Implementing SS-MIX: What can be done?
Michio Kimura, MD, PhD, FACMI
Hamamatsu University School of Medicine, Japan
Professor and Director, Department of Medical Informatics
SS-MIX Could Make a Difference in Postmarketing Surveys and Pharmacoepidemiological Studies
Kotonari Aoki, MS
Chugai Pharmaceutical Co., Ltd., Japan
Head of Real World Data Science Dept. Drug Safety Div.
SS-MIX Could Make a Difference in Drug Developments and Clinical Trials
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
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