Periodic Safety Update Reports Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Periodic Safety Update Reports flashcards as text
How does the concept of a 'PSUR Work Sharing' procedure benefit MAHs with nationally authorized products in the EU?
Answer: It allows a single authority to lead the assessment on behalf of multiple member states, reducing duplicate reviews
PSUR Work Sharing enables one EU member state to lead the assessment while others participate, preventing each country from independently reviewing the same data.
Under ICH E2C(R2), what approach should be taken when evaluating signals identified during the reporting interval in a PSUR?
Answer: Assess each signal for its validity, clinical relevance, and impact on the benefit-risk profile
The MAH must evaluate each identified signal for strength of evidence, clinical significance, and whether the benefit-risk balance is affected, proposing actions accordingly.
What is a 'Risk Minimization Measure Effectiveness' evaluation in the context of a PSUR?
Answer: An assessment of whether implemented risk minimization actions have reduced the identified risks as intended
PSURs should include assessment of effectiveness of risk minimization measures to verify that previously implemented actions are achieving their intended risk reduction.
A product's PSUR covers a 3-year interval. During review, the company finds no new safety signals and the benefit-risk remains favorable. What is the appropriate PSUR conclusion?
Answer: Positive benefit-risk balance maintained; no changes to RSI or risk minimization required
A conclusion affirming a positive and unchanged benefit-risk balance with no required action is a valid and complete PSUR outcome when supported by evidence.
Which of the following best describes 'cumulative data' in the context of a PSUR?
Answer: All safety data collected from the IBD through the current data lock point
Cumulative data in a PSUR spans from the International Birth Date (IBD) to the current data lock point, covering the product's entire post-authorization history.
For a product authorized under exceptional circumstances in the EU, what additional PSUR-related obligation may apply?
Answer: Annual reassessment of the benefit-risk balance as a condition of the authorization
Products authorized under exceptional circumstances have ongoing annual benefit-risk reassessment obligations due to the limited data available at approval.
When a PSUR identifies that the risk of a particular adverse event has increased significantly since the last reporting period, what is the MAH's expected immediate action?
Answer: Propose risk minimization measures and notify the relevant regulatory authorities promptly
Significant increases in identified risks require the MAH to propose immediate risk minimization measures and proactively communicate with regulators across all relevant markets.