Realizing a Regional Approach to Pharmacovigilance
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Washington, DC: World Bank
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This report reviews the
pharmacovigilance system of the European Union (EU) mapping
out its structure and processes with any eye to features
that may be of particular interest to decision makers in
other regions as they weigh options related to creating a
regional pharmacovigilance architecture for themselves. It
begins with a review of the European Medicines Agency (EMA),
which plays a central role in the EU system, followed by an
overview of the EU PV assessment and monitoring process and
an example of the system in action regarding COVID-19
vaccines. It concludes with a summary several key insights
of particular relevance for decision makers.
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Palabras clave
EMA, PHARMACOVIGILANCE, COVID-19 VACCINES