GVP Module VII Explained: The EU PSUR

The PSUR should evaluate only events occurring during the interval and exclude historical knowledge The reporting interval defines the period for systematic new-data evaluation, while cumulative knowledge provides context for the current assessment The product's entire history replaces the need for a defined reporting interval Historical data may be used only if no new information is available

Personally authoring every section of every PSUR Replacing all functional reviewers with personal review Providing oversight through a pharmacovigilance system that identifies, escalates and manages significant safety issues Approving reports without needing visibility into the supporting quality system

Select the lower frequency to avoid overstating risk Select the higher frequency because it is more precautionary Investigate the discrepancy, document possible causes and reflect the limitations in the interpretation Average the frequencies without further investigation

It belongs only in the PSUR and need not enter the ICSR process It should be controlled within the ICSR process and may also contribute to the PSUR evaluation It must be excluded from the PSUR because literature is a separate source It should be treated automatically as a validated signal

To provide a periodic evaluation of the medicine's safety profile and benefit-risk balance To replace the individual case safety reporting system To describe only the marketing authorisation holder's risk-minimisation activities To provide a chronological archive of every adverse reaction report

They are identical processes performed on different dates Signal management is continuous, while the PSUR is a periodic assessment that can use or generate information relevant to signal evaluation Signal management ends once the PSUR has been submitted The PSUR may include only signals that were validated before the reporting interval began

Because scientific evaluation is unnecessary once the format is confirmed Because technical and procedural requirements can change and an otherwise adequate report may be rejected or create compliance issues if submitted incorrectly Because the DLP can be changed by the submission system Because technical requirements determine the product's benefit-risk balance

Allowing each MAH to prepare an entirely independent conclusion without reconciliation Defining responsibilities for data exchange, reconciliation, review, disagreements and communication within the applicable procedure Restricting the assessment to the data held by the largest MAH Avoiding common reference information to preserve organisational independence

It marks the date on which the marketing authorisation expires It closes the defined data set for the reporting interval and establishes a controlled boundary for inclusion of information It is the date by which all regulatory follow-up must be completed It determines whether a medicine is subject to PSUSA

That the risk has disappeared That the risk is no longer clinically relevant Nothing by itself about whether the established risk remains important or adequately managed That the risk should be removed from the RMP immediately