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Researches to Utilize Administrative and Claims Data as A Real-World Data for Regulatory Purpose
Session Chair(s)
Nobuhiro Handa, DrMed, MD, PhD
Principal Reviewer, Office of Medical Device I
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Administrative Claims are important data sources for analyzing real world clinical practice . They have potentials to provide the answers for questions which were left in premarket evaluation. regulatory science research activities will be discussed
Learning Objective : Administrative Claims as a real world data are important data sources for analyzing real world clinical practice. They have potentials to provide the answers for questions which were left in premarket evaluation. Claims are suitable for collecting late event so that long-term assessment for benefits and risk of medical products in anticipated. Recent regulatory science research will be discussed
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