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Risk Management Plan

All applications for marketing authorization in the EU must include a detailed and complex Risk Management Plan (RMP). RMP includes information on

  • Drug safety profile
  • How known or potential risks can be monitored
  • How they can be mitigated to optimize the risk benefit balance
  • Plans for further evaluation of the safety efficacy profile.

  • In lieu of the additional information which keeps surfacing in the drug's safety scenario, there is a compelling need to continually modify and update the RMP.

    Why AWINSA

    To competently perform a rectifying process, two critical incident responses are warranted–authenticated information and capability of organization so that RMPs can be lifted from risk control to risk intelligence.

    Armed with the right set of tools, procedures, knowledge and insight, our team can provide a clear articulation of the requisite spatial framework for RMPs and progressive plans on detailing. They can shed light on the variables that lead to risk so that you can focus on what matters the most. This will enable you to deal with issues in their smallest state before they grow to unmanageable proportions.

    Assessment of Risk Benefit

    The EU regulations and Guideline on Good Pharmacovigilance Practices require companies to continuously monitor the benefits and risks of their marketed medicines.

    This is quintessential to maintain the delicate balance between the safety and efficacy of drugs and is the corner stone of drug safety. It involves numerous activities like review of available literature, regular evaluation of the adverse effects received by the company and preparation of PSUR. As is obvious, weighing the risks and benefits of a drug is a complex process since it involves evaluation of a staggeringly large volume of data and is also limited by the fact that the information available at a given point of time is being studied and as is said there is a risk of missing the "unknown unknowns".

    Inevitably this would require strong academics and robust processes so that these activities can be done systematically and are transparent and scientifically sound. The team at AWINSA Life Sciences is apt for this exhaustive job and will ensure uninterrupted delivery of services for you.