Reporting of adverse events for marketed drugs: Need for strengthening safety database

Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry,...

Full description

Bibliographic Details
Main Author:	Aditi Anand Apte
Format:	Article
Language:	English
Published:	Wolters Kluwer Medknow Publications 2016-01-01
Series:	Perspectives in Clinical Research
Subjects:	Adverse events marketed drugs pharmacovigilance
Online Access:	http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=3;spage=111;epage=114;aulast=Apte

id	doaj-857dec987d8c4b51ae7e0d380eaa993d
record_format	Article
spelling	doaj-857dec987d8c4b51ae7e0d380eaa993d2020-11-25T00:27:38ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852016-01-017311111410.4103/2229-3485.184781Reporting of adverse events for marketed drugs: Need for strengthening safety databaseAditi Anand AptePharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders.http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=3;spage=111;epage=114;aulast=ApteAdverse eventsmarketed drugspharmacovigilance
collection	DOAJ
language	English
format	Article
sources	DOAJ
author	Aditi Anand Apte
spellingShingle	Aditi Anand Apte Reporting of adverse events for marketed drugs: Need for strengthening safety database Perspectives in Clinical Research Adverse events marketed drugs pharmacovigilance
author_facet	Aditi Anand Apte
author_sort	Aditi Anand Apte
title	Reporting of adverse events for marketed drugs: Need for strengthening safety database
title_short	Reporting of adverse events for marketed drugs: Need for strengthening safety database
title_full	Reporting of adverse events for marketed drugs: Need for strengthening safety database
title_fullStr	Reporting of adverse events for marketed drugs: Need for strengthening safety database
title_full_unstemmed	Reporting of adverse events for marketed drugs: Need for strengthening safety database
title_sort	reporting of adverse events for marketed drugs: need for strengthening safety database
publisher	Wolters Kluwer Medknow Publications
series	Perspectives in Clinical Research
issn	2229-3485
publishDate	2016-01-01
description	Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders.
topic	Adverse events marketed drugs pharmacovigilance
url	http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=3;spage=111;epage=114;aulast=Apte
work_keys_str_mv	AT aditianandapte reportingofadverseeventsformarketeddrugsneedforstrengtheningsafetydatabase
_version_	1725338701541670912

Reporting of adverse events for marketed drugs: Need for strengthening safety database

Similar Items