Benefit-Risk Management – RMP, REMS.
What is Benefit-Risk management?
Benefit-Risk management is undertaken to safeguard the use of medicines with the aim of ensuring that the benefits of a medicinal product outweigh the risks from the use of that product for a particular indication, for individuals and the target population.
What is a Risk Management Plan (RMP), and a Risk Evaluation and Mitigation Strategy (REMS)?
A Risk Management Plan (RMP) contains the following stages and information:
- The identification and characterization of the safety profile of the medicinal product.
- The pharmacovigilance activities planned to characterize existing risks and identify any new risks.
- A Risk Evaluation and Mitigation Strategy (REMS) to implement and assess the effectiveness of these activities.
- Any post-marketing approval requirements for marketing authorization.
The pharmacovigilance activities undertaken could be, for example, information included in the Product Information Leaflet (PIL), or a Post Authorization Safety Study (PASS), or educational and support programs for prescribers and patients.
Whatever the activity, identifying how the effectiveness of these activities in minimizing risk will be monitored is required.
All these stages together form a RMP, which must be submitted for marketing authorization. An effective Risk Management System and the development and update of EU mandatory Risk Management Plans are therefore a critical part of pharmacovigilance and patient safety.
If you don’t effectively monitor for Important Identified and Potential Risks or missing information, your Marketing Authorization or Application is itself at risk.
Risk management strategy development.
Benefit-Risk evaluation is critical to create a risk management strategy and Risk Management Plan (RMP) that is clearly articulated and capable of withstanding regulatory scrutiny.
Through a lean risk management strategy including semi-quantitative methodology aligned with BRAT and PrOACT-URL decision making, we can support the preparation of your RMP and Risk Evaluation and Mitigation Strategy (REMS), to fulfil all EMA and FDA requirements.
Using Benefit-Risk assessment consistent with that used by key authorities, we can identify what is most important and through the subsequent RMP can reduce comments received during assessment, as well as mitigate costs associated with potential imposed studies or additional Risk Minimization Measures (aRMM).
Local risk management.
While it is necessary to have a well-developed and articulated core RMP, there will be situations that demand an approach tailored to an individual territory. That could be because of a safety risk that’s significant for a population prevalent in that territory, or regulatory requirements demand an RMP in the local language or format.
Regardless of why your RMP may need specific local tailoring, our team of experts is here to support you with identifying those issues, creating the solutions, and meeting all your needs from preparation to submission.
A structured methodology for Benefit-Risk assessment.
The need for structured Benefit-Risk governance and assessment processes is increasing as pharma companies seek to navigate regulatory landscapes, bring products to market more efficiently, and of course ensure patient safety.
Increasingly, it makes sense to consider a product’s Benefit-Risk profile much earlier on in the product lifecycle, when you are trying to optimize the benefits and position risks of the product to maximize the chances of authorization.
What is needed is a structure to assess Benefit-Risk during all stages of the pharma product lifecycle, from development to post-marketing.
To address this, we have developed a guide that outlines a structured methodology for managing end-to-end Benefit-Risk management.
Selected PV Case Studies.
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Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
The project team has been fantastic to work with from the initial onboarding/transition continuing through daily maintenance. In particular, I really appreciate that when I send a request to Ines, I do not need to follow up repeatedly or request status updates – everything is simply taken care of!
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.