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Asian Journal of Research in Pharmaceutical Science
Year : 2019, Volume : 9, Issue : 2
First page : ( 107) Last page : ( 111)
Print ISSN : 2231-5640. Online ISSN : 2231-5659.
Article DOI : 10.5958/2231-5659.2019.00016.X

Pharmacovigilance: An Overview

Nikam Nikita R.*, Vakhariya Rohan R., Dr. Magdum C. S.

Rajarambapu College of Pharmacy, Kasegaon, Dist-Sangli, Tal-Walwa, Maharashtra

*Corresponding Author E-mail: nikitanikam10@gmail.com

Online published on 3 July, 2019.

Abstract

Pharmacovigilines can be defined as science and activity to identify, evaluate, understand and prevent against any adverse drug reaction or any other drug-related problems Data collected from PV recommendations on CVSCO CDSCO has already instructed the marketing authority holder (MAH) to comply with it and has also done research on Drugs and Cosmetics Act and Rules. The emergence of Pharmacovigilians in India is up to 1986, when the formal ADR monitoring system comprises of 12 regional centers, each has a population of 50 million. National Pharmacology Program established in January 2005. Operational overview of pharmacovigilens begins with a variety of sources of safety, in which everyone has the capability to create personal hair, including clinical trials data, safety call center, automatic reports and material discovery. The overall data is analyzed about security problems and the risks against profit are assessed and regular security update reports (PSURs) are submitted to the regulatory authority as additional security information is collected. It's been in the life of the product.

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Keywords

Pharmacovigilance, CDSCO, clinical trials, regulatory authority.

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