Risk Evaluation and Mitigation Strategies

Below are the recommended steps for proper implementation of the entire process (US Food and Drug Administration, 2011):

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Put up strategies where new experts and tools which will increase the REMS operational efficiencies.

Oblige all vendors and partnerships to adhere to the risk minimization requirements.

Use technology to enhance coordination and boost safety

Keep the risk management teams updated on the regulatory requirements as stated by the FDA.

Fully coordinate all the stakeholders during the entire process.

Monitor and assess the REMS process by safety signals.

Ensure that the IT department has more sophisticated and specified surveillance infrastructure for proper monitoring.

Communicate with the marketing team and stakeholders on the new strategies and positioning.

Conduct an annual review to identify emerging risks and potentials of the new drugs.

Establish an internal on-call group that will articulate the benefits and risk profiles of the new drugs.

Cost calculations for the medical facility's REMS project can be approached in three ways first is the history of the hospital where accounts are done estimated on average duration, and its historical records are used to the projects schedule. Mathematical estimations are next where calculations are based on the time taken to produce a products size and numbers. Thirdly, is estimating by expert judgment where a professional uses his experience in a particular field to calculate the activity's duration through their personal knowledge. For such a sensitive situation the medical centre is best placed to use either the experts' estimation or the mathematical calculation (US Food and Drug Administration, 2011). This is because both methods are more accurate and precise for large businesses.

When a project manager embarks on format scheduling using an AON algorithm they should evaluate whether some supplementary terminologies have been presented to account for time delay associated with the node during the task activity (Vanhoucke, 2012). These terminologies included are earliest start (ES), earliest finish (EF), latest start (LF), and latest finish (LF) for time and the nodes activity.

The scope of this entire project will be established regarding its size, duration, settings, financing, and geography. The REMS team will be responsible for shaping, setting objectives and purpose of the whole process. Due to the magnificence of the project, it will be important to articulate where the company will source its resources to fund the process to a successful completion. Therefore, their resources will come from foundations, government, health plan providers, patient groups, private funding, product manufacturers, professional society i.e. the pharmaceutical industry, and other multiple sponsors. Nonetheless, it is possible that this process may face some constraints relating to regulatory requirement especially those that are imposed by the FDA (US Food and Drug Administration, 2011). Also, national research interests will be regarded as restriction factors for the entire process. The national coverage decisions that are imposed by the CMS on reimbursement together with insurance requirement will further constrain the implementation of this process.

References

US Food and Drug Administration. (2011). Approved risk evaluation and mitigation strategies

(REMS). Available from FDA website. Accessed.Vanhoucke, M. (2012). Project management with dynamic scheduling. Spirnger BerlingHeidelberg.