,Pharmacovigilance Risk Management Plan - Overview
A well-designed Pharmacovigilance Risk Management Plan is essential for mitigating risks associated with pharmaceuticals and biologics. Risk Management in pharmacovigilance involves identifying important identified and potential risks, missing information, and implementing a Routine Risk Minimization Measure as well as an Additional Risk Minimization Measure (aRMM) when required.
In the EU, RMPs are mandatory for all new medicines and must be submitted as part of the regulatory submission dossier for Marketing Authorization Application (MAA). The RMP details the drug’s safety profile, outlines risk mitigation strategies, and serves as a living document that is updated throughout the product lifecycle.
Risk Evaluation and Mitigation Strategy (REMS)
In the US, a REMS may be required by the FDA to manage specific risks, though unlike the EU-RMP, it is not mandatory for every new drug application. This includes communication plans, medication guides, elements to assure safe use (ETASU), and timetables for submission of assessments. Freyr helps pharmaceutical companies prepare and maintain REMS documentation, ensuring compliance and seamless interaction with the US-FDA.
Pharmacovigilance Risk Management Plan
Freyr provides strategic and tactical support for developing, updating, and implementing Pharmacovigilance Risk Management Plan (RMP) that meets local and global regulatory requirements. Our services include:
- Granular document-level gap analysis
- Quick review of source documents and detailed version tracking
- Revising and updating the RMP following regulatory feedback
Designing targeted questionnaires and educational material for risk mitigation
By partnering with Freyr, companies benefit from:
- End-to-end support for RMP/REMS preparation, reporting, and Regulatory Authority communication
- Assistance in filing NDA/ANDAs and developing Single Shared Systems (SSS)
- Proactive risk identification and mitigation strategies
- Reliable collaboration to ensure regulatory compliance and market continuity
