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Vol. 8, Issue 8 (2019)

Pharmacovigilance: Present status and future perspectives

Author(s):
Dr. Alka Sawarkar, Dr. RK Sharma, Dr. Vidhi Gautam, Dr. K Shramankar and Dr. Neelam Dinodia
Abstract:
Pharmacovigilance is a science which deals with relating to the adverse drug reaction, detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term adverse effects of medicines. Pharmacovigilance is an important and integral part of clinical research with a number of recent high-profile drug withdrawals, like Cerivastatin. Recently the pharmaceutical industry and regulatory agencies have raised the issue of Pharmacovigilance, because of withdrwal of a number of high profile drugs like Cervistatin (Carvalho, 2016).
Early detection of signals from both clinical trials and post marketing surveillance studies have now been adapted by major pharmaceutical companies in order to identify the risks associated with the medicinal product and effectively manage the risks by applying robust risk management plans throughout the life cycle of the product. Signal detection and risk management have added a new dimension to the field of pharmacovigilance, an evolving discipline; it requires ongoing refinement in order to increase its applicability and value to public health. There is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product. This will enable integration of good pharmacovigilance practice in the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post-marketing surveillance (Gildeeva, 2016).
Surveillance system is to ensure the safety of veterinary medicines once they are authorized and being used in the market place (Saygi, 2016). The rapid identification of any adverse effects to medicines is essential and the data produced from the investigation should be assessed in order to reduce risks in the future use of the product (Das et al., 2014).
Pages: 84-92  |  106 Views  6 Downloads
How to cite this article:
Dr. Alka Sawarkar, Dr. RK Sharma, Dr. Vidhi Gautam, Dr. K Shramankar and Dr. Neelam Dinodia. Pharmacovigilance: Present status and future perspectives. The Pharma Innovation Journal. 2019; 8(8): 84-92.
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