European Journal of Biomedical and Pharmaceutical Sciences

GOOD PHARMACOVIGILANCE PRACTICES: A GENERAL REVIEW

Aditi Kasture, Vaishnavi Gone and *Dr. Pradnya B. Patil

ABSTRACT

This review article primarily focuses on pharmacovigilance activities in the European Economic Area (EEA), which recently launched a new operational plan for the development of operational activity with anticipated timelines. It also focuses on Good Pharmacovigilance Practices (GVP), which analyze safety data from unrestricted reporting systems and have been shown to be valuable for identifying risks associated with marketed medicines. GVP also includes more modules of implemented guidelines. The EV system outlines the major initiatives and events that will affect or be related to it and its stakeholders during the course of the following three years, from 2018 to 2020. Protecting public health and supporting EU pharmacovigilance efforts are the primary goals of ensuring the sustainability of EV and related operations. In terms of dates and new initiatives/developments, the operation plan will be revised on a regular basis. A platform for learning, collaboration, and alignment throughout the development and operation of EV is also ensured by covering system contact with the stakeholders as part of training and communication engagement. Maintaining effective reporting standards to prevent adverse reactions and increasing the beneficial effects of drugs on the population are covered by GVP. The guidelines are based on pharmacovigilance processes and population or product specific considerations.

Keywords: Good Pharmacovigilance Practice, Pharmacovigilance, World Health Organisation, Modules, European Medicine Agency.