OBJECTIVE To assess the pharmacovigilance awareness among the healthcare professionals in a teaching hospital in Northern India. MATERIAL AND METHODS A questionnaire which was suitable for assessing the basic Knowledge, Attitude and the Practice (KAP) of pharmacovigilance was designed and distributed among 100 doctors of the Punjab Institute of Medical Sciences (PIMS) Hospital, Jalandhar, Pun...

INTRODUCTION In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. OBJECTIVE In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pha...

In July and August 2014, the European Medicines Agency (EMA) organised two public consultations concerning European pharmacovigilance. These two consultations reveal a number of EMA proposals that are counterproductive to the objective of improving transparency over pharmacovigilance data. The EMA's proposals offer pharmaceutical companies an opportunity to participate in public hearings held b...

The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting.In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university sett...

Pharmacovigilance is a corrective process originating in pharmaco-epidemiology. The 1997 Erice Declaration, presented at the World Health Organisation, became the basis on which the concept was implemented internationally for conventional systems of medicine. The increasing international acceptance of Ayurveda, led regulators to implement a similar program for Ayurveda, particularly as some med...

We read with great interest the article by Hisham AlJadhey et al1 regarding the major challenges facing pharmacovigilance in the Kingdom of Saudi Arabia (KSA). We have been associated with pharmacovigilance in Nepal for many years. The first author was involved with the establishment and the operation of 2 regional pharmacovigilance centers in the country, and the second author is the chief pha...

Pharmacovigilance, the scientific discipline pertaining to drug safety, has been studied extensively and is progressing continuously. In this field, medical informatics techniques interpretation play important roles, appropriate approaches are required. study, we investigated analyzed trends of pharmacovigilance systems, especially data collection, detection, assessment, monitoring processes. W...

Background: The aim of present cross-sectional survey is to investigate healthcare workers' knowledge, attitude, and behaviour regarding pharmacovigilance at tertiary care hospital, Faisalabad. Methods: was conducted in study populations Eighty (80) male female health workers were included this study. Demographic data information about collected on an interview schedule administered through cus...

Background: Pharmacovigilance not only helps in the early detection of adverse drug reactions (ADRs) but also facilitates identification both, risk factors and underlying mechanism. To increase reporting rate, it is essential to improve knowledge, attitude, practices (KAP) healthcare professionals regarding ADR pharmacovigilance, especially during undergraduate postgraduate education. The objec...