background pharmacovigilance (pv) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. this paper describes the pv systems of india, uganda and south africa based on literature and key informant (ki) interviews and compares them with the world health organization’s (who’s) minimum pv requirements for a functional national pv syste...

The review outlines the current issues of Pharmacovigilance System in the Russian Federation, namely present state of regulatory aspects of PV system in Russia, regulatory requirements in Russia and in Eurasian Economic Union, review of the causes of under-reporting of ADRs. Specific focus has been made on topical issues such as a harmonization of the requirements to the Pharmacovigilance Syste...

The review outlines the current issues of Pharmacovigilance System in the Russian Federation, namely present state of regulatory aspects of PV system in Russia, regulatory requirements in Russia and in Eurasian Economic Union, review of the causes of under-reporting of ADRs. Specific focus has been made on topical issues such as a harmonization of the requirements to the Pharmacovigilance Syste...

The drug is unique commodity as being life saving and improves quality of life when used rationally, but it becomes life threatening when used irrationally/ inappropriately. Efficacy, safety and quality of the drugs are three most important characteristics in any registration criteria anywhere on the globe. However, pre registration research/studies on theses aspects can not be extrapolated to ...

IJMDS ● www.ijmds.org ● July 2017; 6(2) 1498 Original Article Assessment of knowledge, attitude and practice of Pharmacovigilance among the interns in a tertiary care hospital in northern IndiaA questionnaire based study Garg P, Sharma V, Bajaj JK ABSTRACT Background: The use of drugs and occurrence of its ADRs go hand in hand. Spontaneous reporting of ADRs is an effective method and needs to b...

The pharmaceutical companies are getting more inclined towards patient support programs (PSPs) which assist patients and/or healthcare professionals (HCPs) in more desirable disease management and cost-effective treatment. The utmost objective of these programs is patient care. The PSPs may include financial assistance to patients, medicine compliance programs, access to HCPs via phone or onlin...

Accurate and timely identification of post-marketing drug safety risks (the so-called “signals” in pharmacovigilance) is an important public health issue. While various computational methods have been proposed to analyze the diverse data sources employed for signal detection, still the challenge of effective drug monitoring and surveillance remains. On the other hand, there is an emerging belie...

With many drugs coming to market and post-marketing surveillance limited to industry, there is a need for an integrated common approach to pharmacovigilance (PV) in the Eastern Mediterranean Region (EMR)/Arab region. The first meeting of the EMR/Arab countries for PV involved ten of the 22 states and revealed how these countries are learning from and working with each other in order to achieve ...

BACKGROUND Due to the limited safety data available at the time that a new medication is first marketed, it is essential to continue the collection and monitoring of safety data about adverse drug reactions (ADRs) during the medication's life cycle. This activity, known as pharmacovigilance (PV), is performed worldwide by the pharmaceutical industry as well as by regulatory agencies. In 2012, t...

© 2017 Ancient Science of Life | Published by Wolters Kluwer Medknow Sir, There is a paucity of systematic documentation apropos the occurrence of adverse drug reactions (ADRs) and other safety issues of Ayurveda medicines. National Pharmacovigilance program (NPP) for Ayurvedic drugs is concerned with re‐evaluation of marketed drugs, risk management, promoting rational drug use, and crisis prep...