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Session 1 - How Should We Collect and Leverage the Medical Data in the "Real World"?
Session Chair(s)
Mika Ogasawara
Data Quality Lead, Biometrics and Data Management
Pfizer R&D Japan G.K., Japan
Motohide Nishi, MBA
Japan Site Leader & VP Professional Services
Medidata Solutions K.K., Japan
How should we collect and leverage the medical data in the “real world” after drugs/ medical devices are launched in order to make the information more beneficial to patients, healthcare workers, government, academia and industry? In this session we will have various discussions about the real world data (RWD) post new drug/medical device approval, e.g. current situation and future possibilities. A drug lag issue is being eliminated and now drug discovery form Japan and “Iku-yaku” have become a hot topic in Japan. So, we believe it is time to rethink about what and how to collect and utilize the post-marketing study/surveillance data and RWD, and furthermore consider the other methodologies to leverage the RWD for providing the better means of cure. This session is expected to inspire the audience to learn and think about data management in non-interventional studies and data science for RWD.
Speaker(s)
Central Real World Informatics Function: Operational and Organizational Considerations
Nathan R. Crisel
Astellas US LLC, United States
Director, Real World Informatics and Analytics Function
Use of Real World Data
Kotonari Aoki, MS
Chugai Pharmaceutical Co., Ltd., Japan
Head of Real World Data Science Dept. Drug Safety Div.
Yasuhiro Fujiwara, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Executive
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
Hironobu Saito, PhD
Tottori University, Chromosome Egineering Research Center, Japan
Specially Appointed Professor
Mayumi Shikano, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Center Director (for Advanced Review with Electronic Data Promotion)
Steve Wilson, PhD
FDA, United States
Senior Staff Fellow, OB, OTS, CDER
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