Introduction to Risk Management Plan | Operations Online Course by Udemy

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RMP creation, methods and evalution of RMP plan

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Introduction to Risk Management Plan

It is a RMP document that provide synopsis of safety profile of the pharmaceutical products, it covers epidemiology, clinical part of safety specification, long term exposure and short term exposure safety measures, how to define population not studied in clinical trials, long term post marketing, how to develop safety concerns, experiences, what are risk measures, and minimization activities, and how to measure the factor constantly. Risk management is required for all products, (vaccine, drug or device) It clearly defines the parameters not studies in early phase and what items requirement to be clearly measured. Product that have long term safety established RMP is updated to current SOC level. RMP enable to clear the doubts about the product, it include design level approach to conduct a studies on specific outcome of the AE. Outcome measures such as per day consumption, cost and related events provide information for regulatory recommendations. RMP monitors all ingredients present in the medicinal product such as additives, stabilizer etc. RMP collectively allow the MAHto understand the long term safety plan and level of observation / studies required for the IMP for the MAH. Most of the regulatory agency compare the outcome measures and establish guidelines and recommendation for the use of the drug

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