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KMID : 1011320210130020087
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Journal of Pharmacoepidemiology and Risk Management
2021 Volume.13 No. 2 p.87 ~ p.90
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Paradigm Shift of Pharmacovigilance: 10 Years’ Experience of Active Surveillance by One Regional Pharmacovigilance Center
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Lee Myung-Goo
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Abstract
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21st century pharmacovigilance is not merely about the identification of adverse events but also includes systemic preand post-market surveillance and a complete understanding of the risks associated with certain drugs. In an era where biologics, biosimilars and immune checkpoint inhibitors are becoming increasingly available, a more holistic approach to pharmacovigilance is necessary to ensure the safe and effective use of these drugs. Although active surveillance systems based on a common data model (CDM) approach present a promising solution to the limitations of the current spontaneous reporting system, a multi-center study using a comprehensive registry is an another option in the transitional stage. This study explores several alternatives for pharmacovigilance to the current spontaneous reporting system.
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KEYWORD
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Pharmacovigilance, Adverse drug reaction reporting systems, Biological products
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