J Pharmacoepidemiol Risk Manage.  2021 Sep;13(2):87-90. 10.56142/2021.13.2.87.

Paradigm Shift of Pharmacovigilance: 10 Years’ Experience of Active Surveillance by One Regional Pharmacovigilance Center

• Lee MG

• KMID: 2534667
• DOI: http://doi.org/10.56142/2021.13.2.87

Abstract

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.

Keyword

Pharmacovigilance; Adverse drug reaction reporting systems; Biological products