Risk Management System

Pharmacovigilance encompasses much more than merely identifying new risks associated with medications; it involves actively engaging in measures to mitigate these risks.

This proactive approach requires a deep understanding of pharmacovigilance and patient safety disciplines, coupled with a detailed knowledge of the local healthcare setting and a complete awareness of the applicable legal and regulatory structures.

In addition to the Pharmacovigilance System described within a Pharmacovigilance System Master File (PSMF), a Risk Management System must be described in a Risk Management Plan (RMP) for all EU medicinal products, and in over 40 other jurisdictions worldwide.

The Risk Management System is structured based on the Safety Specifications of an individual product. It encompasses a series of activities detailed in the Pharmacovigilance Plan aimed at enhancing our understanding of its safety profile, while interventions in the form of Risk Minimisation Measures (RMMs) are outlined in the Risk Minimisation Plan. This system prioritises important safety concerns, taking into account the risk to both individual and public health, as well as the feasibility of pharmacovigilance activities and interventions. Our design incorporates a Burden Analysis to guarantee the most effective risk-proportionate approach.

How iVigee can support you.

iVigee can create and implement all your EU RMPs and their global versions and design all your required additional pharmacovigilance and risk minimisation activities. Typical activities we perform as part of our Risk Management service include:

Developing a full understanding a your product’s benefit/risk journey.

Developing a safety specification and agreement on the important safety concerns.

Selecting the best combination of tools for your pharmacovigilance and risk minimisation activities.

Creating and updating Risk Management Plans, Risk Evaluation and Mitigation Strategies (REMS), and other variants according to local regulations.

Developing and testing additional risk minimisation measures (e.g. aRMM/ETASU), including the metrics methodology for evaluating effectiveness.

Producing digital and physical aRMM materials, including translations, and local testing of their integration with healthcare systems.

The approval of local aRMMs materials with regional/national/local authorities.

The delivery of aRMMs and effectiveness evaluation through both procedural and outcome indicators.

Ad-hoc reporting on aRMM effectiveness, and periodically in PBRERs.

We’re experts in Risk Management.

iVigee’s depth of expertise in Risk Management is unique - we are the only company in the world that has a former EMA Head of Risk Management among its experts.

Our intimate knowledge of all aspects of risk management has been finely developed through the hundreds of RMPs we have reviewed, developed, negotiated, approved, and implemented, all fully confirmed by a successful inspection record.

Through a combination of our global and local regulatory knowledge and our proactive approach to predicting and mitigating potential risks, we can ensure the highest standards of patient safety while maintaining the integrity and success of your product in the market.

Choosing iVigee means partnering with a team committed to excellence, innovation, and a collaborative approach that transforms challenges into opportunities for safeguarding public health and enhancing your product's value.