Risk Management Plan Writing for Marketing Authorisation Holders
Pubrica writes EU risk management plans for marketing authorisation holders, for new applications and for updates to existing plans. Our pharmacovigilance writers prepare RMPs to GVP Module V, covering the safety specification, the pharmacovigilance plan, and risk minimisation measures with their effectiveness assessment. Each risk minimisation measure becomes an obligation with an owner, a budget and an effectiveness assessment, so we size every commitment before it is included and reconcile the plan with your labelling.
- A safety specification that distinguishes important identified risks, important potential risks and missing information, which carry different obligations
- A pharmacovigilance plan proportionate to the risk, with routine activities distinguished from additional activities
- Risk minimisation measures sized before they are proposed, because each one becomes a commitment with a cost and an owner
- Effectiveness assessment specified for each additional measure, which is the section most plans leave underdeveloped
- Consistent with the labelling, because any difference between the RMP and the SmPC in describing the same risk will be questioned
Safety specificationIncluded
Pharmacovigilance planIncluded
Risk minimisation and effectivenessIncluded
RMP updates and versionsIncluded
Operating the safety databaseYour PV function
Safety data → specified → planned → minimised → RMP
- Risk categories correctly assigned
- Activities proportionate to risk
- Commitments sized before they are proposed
- Effectiveness measurement specified
- Reconciled with the labelling
Deliverables
Four Core Elements of Every Risk Management Plan
Each plan covers one product and its safety profile, and the data available defines what the plan must manage.
Example from a safety specificationHepatotoxicity — identified risk.Important potential risk: a signal from two cases with confounding, insufficient for identified. Categorised as potential, with the characterisation study in the pharmacovigilance plan. The category determines the obligation.
Example from a pharmacovigilance planProposing additional pharmacovigilance for every listed risk leads to a plan the company cannot deliver. GVP Module V treats proportionality as a requirement.
Example from a commitment reviewA physician education programme will be implemented.Flagged before submission as unbounded in scope, territory, duration and cost, and rewritten as a specific, costed programme with an owner and a defined review point.
Example from an effectiveness sectionA measure with no stated effectiveness indicator cannot be shown to work, so it also cannot be withdrawn. Specifying the indicator supports both decisions.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Regulatory Guidelines and Standards for Risk Management Plans
Where your agency or your safety function has a stated position, we follow it.
Good pharmacovigilance practices (risk management systems)
Sets the structure and content of the EU risk management plan, the proportionality principle and the expectations for effectiveness assessment.
Pharmacovigilance planning (safety specification)
Provides the basis for the safety specification and for distinguishing routine from additional pharmacovigilance activities.
Product information (consistency requirement)
The RMP and the labelling describe the same risks. Any difference between them will be questioned and may become a finding.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our quality management system governs how each document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a named individual. For this reason, source traceability takes priority over speed in our regulatory writing, and every statement must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our Risk Management Plan Writing Process Works
We categorise each risk first, because its category determines the obligations that follow.
Safety Data Review and Risk Categorisation
We assess the clinical and post-market safety data and categorise each concern as an important identified risk, an important potential risk or missing information.
Pharmacovigilance Planning
We propose routine and additional activities in proportion to the risk, and scope and cost any additional study before it is included in the plan.
Risk minimisation and effectiveness
We select, size and assign an owner to each measure, and specify the effectiveness indicator, source and timing for each additional measure.
Reconciliation and Release
We check the plan against the SmPC and package leaflet so that each risk is described consistently, then release it with the update cadence set.
Our Experts
Your Risk Management Plan Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Risk Management Plan Service Packages
Pricing depends on the product, the number of important risks and whether additional activities and measures are in scope.
Risk management plan
For marketing authorisation applications and new products
Quoted per projectBased on product and risk profile
Delivery By scope
- ✓Safety specification with categories justified
- ✓Proportionate pharmacovigilance plan
- ✓Risk minimisation measures sized and owned
- ✓Effectiveness measurement specified
- ✓Reconciled with the SmPC and leaflet
- ✓Two review cycles
We review commitments for deliverability before they are included in the plan.
Deliverables Request a quoteRMP update
For products with an existing plan
Quoted per projectBased on what has changed
Delivery By scope
- ✓New safety data assessed and risks recategorised where warranted
- ✓Completed activities closed out
- ✓Effectiveness results incorporated
- ✓Measures reconsidered where effectiveness is demonstrated
- ✓Version and change summary for the agency
An update is also the point at which a measure that has achieved its purpose can be withdrawn, provided its effectiveness indicator was specified.
Deliverables Request a quoteSend your current RMP and we will review the risk minimisation section at no cost for commitments that are unbounded in scope, territory, duration or cost.
FAQs
Risk Management Plan FAQs
If your question is not answered here, ask an expert. No quote is required.
Because the category determines the obligation. An important identified risk carries different pharmacovigilance and minimisation expectations from an important potential risk, and missing information carries different ones again.
Categorising a signal as an identified risk when the evidence supports a potential risk adds obligations you did not need to take on, and the reverse is likely to be challenged.
Proposing additional activities for every risk often leads to a plan the company cannot deliver. GVP Module V expects proportionality, and a plan that proposes additional activity for every listed risk will be questioned.
Routine pharmacovigilance is adequate for most concerns. Additional activity should be proposed only where routine activity will not answer the question.
For each additional risk minimisation measure: what indicator will show whether it is working, where that indicator comes from, and when it will be assessed.
Most plans leave this section underdeveloped, and regulators increasingly point this out. Specifying it also provides the basis on which a measure can later be withdrawn.
No. Case processing, the safety database, signal detection and the QPPV function sit with your pharmacovigilance organisation or a provider that holds those obligations.
We write the plan those functions operate against, and the aggregate safety reports produced from them.
Related Services
Related Regulatory Writing Services
The RMP draws on the safety data and must be consistent with the labelling.
1PERIODIC SAFETY REPORTSshared safety data
PSUR and DSURPeriodic and development safety reports. Patient narrativesDeaths, SAEs and discontinuations.2SUBMISSION DOCUMENTSmust be consistent
Regulatory writingLabelling, dossiers and submissions. CTD module summariesModule 2.5 and 2.7.3SUPPORTING EVIDENCErisk characterisation
BiostatisticsPooled safety analysis. Systematic reviewLiterature-based risk characterisation.Request a Free Review of Your RMP Risk Minimisation Section
We review the measures for commitments that are unbounded in scope, territory, duration or cost, which is where plan commitments become expensive.