Pharmaceutical Risk Management Plan

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PHARMACEUTICAL RISK MANAGEMENT PLAN: AN OVERVIEW Introduction: Risk management is set of Pharmacovigilance activities and intervention designed to identify, characterize, prevent or minimize risk relating to medicinal products including the assessment of effectiveness of the effectiveness of those activities and intervention. Risk assessment means identifying and characterization the nature, frequency, and severity of the risk associated with the use of product. Risk minimization means minimizing product’s risk while preserving its benefits. Risk management is discipline within Pharmacovigilance that is responsible for signal detection and the monitoring of risk benefit profile of drugs. Risk Management Plan: A Risk management plan…show more content…
The main function of risk management plan is to improve Pharmacovigilance by identifying potential safety issue of human medicinal products, presenting how to reduce risk and consequently to increase the knowledge about human medicinal product concerned. Creating a risk management plan is complex, challenging and cross functional process that focuses on evaluating safety issue identified during product development. History of Risk management plan: During the past years, risk management plan has become an important tool for industry as well as for regulators. In particular, pharmaceutical companies as well as regulatory authorities have placed increasing emphasis on how to detect, manage and communicate risk, as not everything is known about the safety of newly approved medicinal products because clinical trials are not able to detect rare drug induced adverse event at the time of approval. As medicinal products are subject strict regulation throughout the product lifecycle, pharmaceutical companies have to provide evidence that their product is effective and safe. Objective of Risk management plan: • Identify or characterize the safety profile of the medicinal products…show more content…
Not every authority requires formal Risk management plan. Other regulated countries like United States, Japan and Australia have established risk management system as well which illustrates the increasing importance of introduction of risk management and specially risk minimization activities. Europe: United States: In the United states food and drug administration act was come in 2007.This act improve the safety of drug by providing FDA with post approval authority over medicinal products and biopharmaceuticals through new risk identification and communication strategies. The format of risk evaluation and mitigation strategy is mentioned in the “Guidance for industry- format and content of proposed risk evaluation and mitigation strategies, REMS assessment and proposed REMS modification” dated on September 2009. This act gives authority to FDA to decide that REMS is necessary, as part of approval process. Japan: In Japan, a regulation under the Ministry of Health, Labour and Welfare ordinance introduced on 1stOctober 2007 as “ Early Phase Post marketing vigilance (EPPV)” and it is serve as an example of an early post marketing risk management

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