Review article

Pharmacovigilance from the Perspective of a Pharmaceutical Company

Mirna Pogačić ; PLIVA Hrvatska d. o. o., Zagreb
Jelena Žanetić ; PLIVA Hrvatska d. o. o., Zagreb
Ana Babić ; PLIVA Hrvatska d. o. o., Zagreb
Mateja Raguž ; PLIVA Hrvatska d. o. o., Zagreb

Abstract

Pharmaceutical companies actively monitor the safety profiles of their marketed medicines as well as those under development, with the purpose of timely detection, prevention or minimization of adverse drug reaction risks. Pharmacovigilance activities in a pharmaceutical company include the collection of adverse event reports in the company safety database, medical analysis of the reports, their reporting to the medicines agencies, as well as systematic and periodic analysis and review of cumulative data. Since pharmacovigilance requirements are clearly defined, with special emphasis on global timely data exchange, tools were designed to make this more efficient and precise; for example the Medical Dictionary for Regulatory Activities (MedDRA). One of the most important pharmacovigilance purposes is detecting new information and risks related to medicines, a process called safety signal detection. This is done by statistical methods and scientific analysis of data on quality, clinical and non-clinical information, pharmacovigilance and pharmacoepidemiological data and published scientific literature.

Keywords

Pharmacovigilance; pharmaceutical industry; adverse event reporting; adverse event assessment; safety profile monitoring; safety signals

Hrčak ID:

185273

URI

https://hrcak.srce.hr/185273

Publication date:

26.7.2017.

Article data in other languages: croatian

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