How we manage your risk, across all life cycle stages.
Risk management strategy development.
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, we can provide the expert preparation of your RMP and risk evaluation and mitigation strategy (REMS) documents, to fulfil all EMA and FDA requirements.
A well-developed RMP can reduce comments received during assessment, as well as mitigate costs associated with potential imposed studies or additional Risk Minimization Measures (aRMM).
An effective Risk Management System and the development and update of RMP – mandatory in the EU, are a critical part of pharmacovigilance and patient safety. If you don’t effectively monitor for Important Identified and Potential Risks or missing information, your MA or Application is itself at risk.
Our regulatory expertise and holistic approach to risk management covers many areas including the identification of safety concerns, determination of potential and identified risks and any missing information for your new product.
Risk management plan (RMP) and risk evaluation and mitigation strategy (REMS).
An effective Risk Management System and the development and update of Risk Management Plans – mandatory in the EU, are 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.
Our risk management experts can identify new safety concerns and propose appropriate and effective risk minimization measures, keeping you compliant whilst improving patient safety.
Development risk management plan.
Setting-up your risk minimization strategy early in your project will ensure there are no delays in the submission of your MA application. Our risk management experts can identify new safety concerns as they arise and propose any appropriate risk minimization measures, keeping you compliant, on budget, whilst improving patient safety.
Local risk management.
While it is a necessity to have a well-developed and articulate core RMP, there will be situations that demand an approach tailored in an individual territory. That could be because of a safety risk that’s significant for a population prevalent in the covered territory, or regulatory requirements that demand a 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.
Safety communication is a broad term covering different types of information on medicinal products. Effective communication to healthcare professionals, patients, and other stakeholders is imperative to promote the safe and effective use of a medicine, and our safety experts can support you to effectively propose, develop and distribute your safety communications.
That includes routine communications such as a Summary of Product Characteristics (SmPC) or Package Information Leaflet (PIL), plus additional routes of communication to communicate newly identified important safety concerns that can have an impact on a medicine’s benefit-risk balance and its condition of use.