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Biovigilance: a study on surveillance system for Blood and vaccines in india and U S

By: Agrawal, Ayushi.
Contributor(s): Shantha Kumar, G.S.
Publisher: 2021 Indian Journal of Pharmaceutical Science 2021Edition: Vol.53(5-6), May-June.Description: 28-36p.Subject(s): PHARMACEUTICSOnline resources: Click here In: Pharma timesSummary: A biological product is a substance that either contains or is derived from a living organism and is used for the prevention or cure of diseases. As these materials are complex, infections, adverse events (AEs) and allergic reactions are always associated with their use. Biovigilance is a set of systematic procedures that are performed to track adverse events that have taken place with the use of the biological product and preventing its recurrence. This method ensures patient safety and improves the quality of life. As the importance of biological products is profound in recent years, several biological products can treat or prevent disease which cannot be treated with traditional drugs. As these products enter the market, it is very crucial to monitor their performance and keep track of the adverse events associated with their use. Nowadays, as the need for vaccines and blood transfusions are a critical part of treating most diseases in every developed country, vigilance activities for vaccines and blood have been well established and developing countries are in an urge to maintain a vigilance system in place to monitor the safety of patients. This article specifically focuses on vigilance systems for vaccines and blood, their history and vigilance programs in India and the US.
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A biological product is a substance that either contains or is derived from a living organism and is used for the prevention or cure of
diseases. As these materials are complex, infections, adverse events (AEs) and allergic reactions are always associated with their use.
Biovigilance is a set of systematic procedures that are performed to track adverse events that have taken place with the use of the
biological product and preventing its recurrence. This method ensures patient safety and improves the quality of life. As the importance
of biological products is profound in recent years, several biological products can treat or prevent disease which cannot be treated
with traditional drugs. As these products enter the market, it is very crucial to monitor their performance and keep track of the adverse
events associated with their use. Nowadays, as the need for vaccines and blood transfusions are a critical part of treating most diseases
in every developed country, vigilance activities for vaccines and blood have been well established and developing countries are in an
urge to maintain a vigilance system in place to monitor the safety of patients. This article specifically focuses on vigilance systems for
vaccines and blood, their history and vigilance programs in India and the US.

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