Knowledge Assessment: Important Potential Risks

Review only when a regulator specifically requests an update Define a routine review schedule together with evidence-based triggers, decision points and criteria for retention, reclassification or removal Review only after the product is withdrawn Use an unspecified future review date so that the team can remain flexible

The event must be added to the RMP as an Important Potential Risk The finding is a signal requiring validation and assessment before any RMP classification decision The event should be classified as an Important Identified Risk because disproportionality demonstrates causality The finding should be disregarded because spontaneous reports cannot contribute to risk assessment

A small number of high-severity signals are prioritised using documented clinical and public-health criteria Every statistical alert is added as an Important Potential Risk without validation, importance assessment or planned action A potential risk is removed after robust negative evidence is reviewed A signal is monitored routinely until additional evidence becomes available

Update the RMP without recording the reason if the change is scientifically obvious Create a documented change request, assess impact, obtain appropriate approval and maintain a dated change log linked to supporting evidence Replace the previous version so that only the current decision is available Allow any individual case processor to amend the classification directly

Allowing the signal detection team to make the final decision without documented review Recording multidisciplinary review, explicit rationale, dissenting views where relevant, named approvals and dates Relying on an informal verbal agreement between two scientists Keeping only the final RMP wording and discarding earlier analyses

Alternative explanations are relevant only to product-quality investigations Confounding, background incidence, comorbidities and concomitant medicines can create or inflate an apparent product-related association Considering alternatives prevents any signal from being classified Alternative explanations are used only after an identified-risk classification

A further isolated spontaneous report without additional clinical information A statistically significant adjusted association in a robust cohort study, supported by consistent clinical evidence A continued absence of adequate epidemiologic data A signal that becomes less frequent after duplicate cases are removed

To ensure that all events with similar medical terms are treated as the same risk To support traceability, consistent tracking, rapid reporting and alignment between the Safety Specification and operational activities To eliminate the need for periodic RMP review To allow database tags to determine causality automatically

The number of new products launched by the company The number of potential risks retained for more than two years without documented review or justification The total number of employees in pharmacovigilance The number of routine adverse-event reports received globally

A reduction in the number of reports during a short observation period An adequately powered, methodologically robust study showing no increased risk, with alternative explanations and signal artefacts addressed A decision that the concern is inconvenient to monitor A single expert opinion that the event is unlikely