About Sollers

Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

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A Risk Management Plan (RMP) For New Applications

Posted by Doctor Erick on Jun 26, 2017 1:53:31 PM

To describe the safety and efficacy of a medicinal product, a risk management plan (RMP) is inevitable and necessary. In fact, it is the kind of document that describes the current knowledge of the existing trends. The knowledge about the safety and efficacy of the medicine could be gained out of additional activities that are performed in order to fetch key information on plans for studies by the RMP. The risks associated with the use of the product in patients would also be described by a risk management plan with the support of measures to be undertaken to prevent or minimize possible glitches. For any new medicinal product for a human use which must be submitted at the time of application for marketing authorization, the Marketing authorization holders are extremely necessary if they should have an RMP.

The HPRA review and approval should be sought for nationally authorized products by RMPs. The requirements set out in Commission formed by RMP will be Implementing Regulation on the performance of pharmacovigilance activities. The corresponding RMP authorities shall be adopting a risk-based approach to RMP updates and there is no longer an automatic requirement to update RMPs on a fixed time basis.

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At the comprehensive request of the authorities belonging to national competent authority, novel risk management plans will be formulated for emerging applications. The modification of RMP plays a significant role when it comes to changing the risk-benefit profile of a medical product or as a result of an important pharmacovigilance or risk minimization milestone being reached. Under the scenario where the need to update an RMP coincide, the date for the submission of a periodic safety update report can also be added along with the existing reports.  For the benefit of a medicinal product, it has become mandatory to enhance the risk minimization tools that are used to stabilize the risk balance. It can be done on the basis of the occurrence of adverse reactions associated with the medicinal product or reducing the severity of reactions that do occur. There are plenty of risk minimization factors that help for the formation of good pharmacovigilance practices provided if the risk management systems including risk management measures and selection of tools are in accordance with the effective indicators.

The risk management plan for a particular application will be outlined by risk minimization measures. There are different types of risk management plans that could be brought into existence. Applications that are dedicated for specific purposes tend to behave in a way causing an excessive disturbance. In other cases, such applications would be routed to random behavioral patterns with respect to the design upon which it is developed. In general, risk management plans cannot afford to get deviated in destined path unless an emergency situation is created wherein the data fetching process becomes marginally complicated. Some of the applications could be filtered while testing the plans of certain risk management scenario just because of the reason to reduce unwanted risks.

It is very important to understand the tools available for risk management plans for respective products. Some of the general types of risk minimization tools are educational programs, controlled access programs, and pregnancy prevention programs including safety communications, such as Direct Healthcare Professional Communications (DHPCs). Quite often these tools will also be used to formulate risk minimization measures providing an effective mode of communication for selected safety issues to patients and practitioners. Most of the times the products designed for the upliftment of software benefits shall be shared with peers in order to regulate a safe and secure mode of operation. There are also a lot of guidelines available in the leading pharmacovigilance portals regarding risk management plans new applications. 

Topics: Drug Safety