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PHARMACOVIGILANCE AND RISK MANAGEMENT. Dilpreet Singh, Kirandeep Kaur, Kamaldeep Kaur, Harwinder Singh Rao

PHARMACOVIGILANCE AND RISK MANAGEMENT.

Dilpreet Singh, Kirandeep Kaur, Kamaldeep Kaur, Harwinder Singh Rao

International Journal of Natural Product Science 2012: Spl Issue 1:204.

Abstract(RBIP-204)

Pharmacovigilance, defined by the World Health Organisation as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’ plays a key role in ensuring that patients receive safe drugs. It is now accepted to be a continuous process of evaluation accompanied by steps to improve safe use of medicines which involves pharmaceutical companies, regulatory authorities, health professionals and patients. The methodologies have broadened to encompass many different types of study, with spontaneous reporting remaining the cornerstone. The aim of risk-management system is to ensure that the benefits of a particular medicine (group of medicine) exceed risk of harms by the greatest achievable margin for the individual and for the target population in general. Risk management activities are routinely applied to investigational drugs through measures such as excluding patients susceptible to particular adverse drug reaction, excluding certain concurrent drugs and concomitant diseases, close monitoring of patients, the use of safely biomarkers and the use of detailed informed consent. New processes, both at a regulatory and a scientific level, are being developed with the aim of strengthening pharmacovigilance.

Keywords: Pharmacovigilance, regulatory, methodologies, Risk management
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