Risk Management Plan (RMP)
Risk management plan built around the safety specification: important identified risks, important potential risks and missing information, each carrying the pharmacovigilance activity that investigates it, the minimisation measure that contains it, and a pre-specified effectiveness indicator. Maps to EU GVP Module V and ICH E2E.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A risk management plan describes a product’s safety profile, what remains uncertain about it, and the activities that will characterise and minimise its risks. Its centre of gravity is the safety specification — the honest statement of important identified risks, important potential risks and missing information. A thin specification produces downstream activities that measure nothing in particular, and that is where the plan usually fails.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
EU GVP Module V sets the risk-management-system requirements for products authorised in the EU, and ICH E2E establishes the safety-specification and pharmacovigilance-planning structure the plan follows. Neither decides what counts as an important potential risk for your product, which populations are genuinely missing information, or when a minimisation measure has worked — those judgements are the marketing authorisation holder’s and are assessed on the reasoning recorded here. The document structure and guidance notes are SPEQ’s practitioner synthesis, not regulator text.