Global Risk Minimisation Measures - aRMM

The need for Risk Minimisation Measures

Following the identification and assessment of a product’s risks, Risk Minimisation Measures (RMMs) form the range of activities that a Marketing Authorisation Holder (MAH) is obligated to put in place to mitigate those risks as part of their overall Risk Management System. They are a legal requirement of Competent Authorities (NCAs) which are put in place to protect patient safety, and failure to employ them may result in non-compliance with the possibilities of fines or other punitive actions.

RMMs are split into two areas; routine RMMs (rRMMs) which are standard practices that apply to all medicinal products, and additional RMMs (aRMMs) which are considered when more specific actions are needed to improve the safe and effective use of the medicinal product.

Given the increased complexity of aRMM management, such activities need a detailed implementation plan, which ensures they are effectively applied and harmonised across all applicable markets. The Implementation plan will be based on the Risk Management Plan (RMP) obligations, the distribution strategy for aRMMs to healthcare professionals and patients, and proactive communication strategies to all other relevant parties (e.g. health authorities, PV partners, etc.).

Key aRMM activities.

iVigee uses a range of rRMM and aRMM activities to ensure safety and compliance, and these include, but are not limited to:

rRMMs –

PV support and the preparation of SmPCs and Patient Leaflets.

Signal detection and management.

Development of targeted follow-up questionnaires.

A review and safety advice regarding the product information.

aRMMs -

The development of educational tools, Direct Healthcare Professional Communication (DHPC) letters, patient alert cards etc.

Providing access to advanced digital tools for aRMM implementation oversight.

The development of Core RMM Implementation Plans.

The development of Local Implementation Plans, tailored to specific regions.

Support with Post Authorisation Safety Study (PASS) documentation preparation, including review and approval by a QPPV.

Translation for all aRMMs.

Acting as a contact point between global and local teams, overseeing the risk minimization measures and ensuring the smooth implementation of RMM Plans.

The preparation of submission packages, and subsequent submission to national competent authorities.

Continuous monitoring of the effectiveness of aRMMs.

The preparation of aRMM effectiveness evaluation reports.

Our holistic approach to risk and technology.

The full scope of rRMM and aRMM Risk Minimisation Measures that can be used to mitigate product risk can be applied by iVigee’s fully experienced QPPV Office Services team, who can also provide all your Core RMM planning, implementation, and evaluation tools to provide a comprehensive Risk Management service.

And as industry and regulators strive to digitalise RMMs to enhance medicinal product safety, iVigee is perfectly poised to capitalise on combining the extensive PV knowledge of our subject matter and IT experts with the innovative technologies, such as our world leading Regulatory Intelligence platform iViReg, for the latest legal requirements in over 90 countries.

iVigee is committed to safeguarding patient health and product safety through the effective implementation of RMMs as part of your strategic and tactical approach to product risk. Partnering with us guarantees delivery and insights, with complete oversight and compliance wherever your products are marketed.