QPPV.COM KNOWLEDGE ASSESSMENT

GVP Module VII Explained: The EU PSUR

Test your understanding of the concepts covered by GVP Module VII Explained: The EU PSUR.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What is the primary regulatory purpose of an EU PSUR?

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

Question 2 of 10 If a PSUR identifies a materially changed understanding of a safety risk while the RMP is unchanged, what should the MAH do first?

Modify the RMP solely to make the documents look identical Assess the scientific and regulatory implications and determine whether an RMP update or other action is warranted Delete the changed conclusion from the PSUR Assume that the RMP can never be changed during the product lifecycle

Question 3 of 10 A literature article describes an adverse reaction and meets the criteria for an ICSR. How should the information be handled?

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

Question 4 of 10 In a PSUR involving multiple MAHs for products with the same active substance, which governance issue is most important?

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

Question 5 of 10 Which quality-control activity most directly tests whether a major PSUR conclusion is scientifically defensible?

Checking only spelling and page numbering Comparing the conclusion with the supporting analyses, tables, source data and relevant cross-functional information Confirming that every section has the same number of pages Ensuring that the report contains no discussion of uncertainty

Question 6 of 10 Information becomes available after the DLP but before PSUR submission. What is the most appropriate organisational response?

Automatically insert it into the report without documenting the change Ignore it because all post-DLP information is permanently excluded Apply current guidance and the controlled procedure, documenting whether and how it is handled Allow the individual author to decide informally without escalation

Question 7 of 10 What does the absence of a newly detected signal establish about an established important risk?

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

Question 8 of 10 Which role best describes appropriate QPPV involvement in the PSUR process?

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

Question 9 of 10 Why is the current EURD list a critical planning control for applicable PSURs?

It replaces the need to establish a data lock point It determines the applicable reference-date and submission schedule for relevant substances It provides the final scientific conclusions for each PSUR It contains the complete adverse-event database for each active substance

Question 10 of 10 What does adequate PSUR traceability enable an inspector or reviewer to do?

Determine which author wrote the longest section Move from an important conclusion through its analysis and tables to the controlled underlying data Confirm that no data were received after the DLP Replace the need for medical review

GVP Module VII Explained: The EU PSUR

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