PVC Periodic Safety Update Reports 3

Question 1

Under ICH E2C(R2), which of the following is NOT a required section of the PSUR?

Accepted Answer

Post-market clinical trial protocols

Answer

The PSUR does not require inclusion of post-market clinical trial protocols; it focuses on safety data summaries, signal evaluations, and benefit-risk analysis.

Question 2

How is cumulative patient exposure typically expressed in a PSUR?

Accepted Answer

As patient-years, units sold, or prescriptions dispensed with appropriate caveats

Answer

Cumulative exposure is commonly expressed as patient-years, units sold, or prescriptions dispensed, with acknowledged limitations of each method.

Question 3

What is the purpose of the 'Summary Tabulations' section in a PSUR?

Accepted Answer

To present cumulative and interval counts of adverse events by system organ class

Answer

Summary tabulations aggregate adverse event counts by system organ class for both the reporting interval and cumulatively, enabling trend analysis.

Question 4

In the PSUR, the 'Interval' data refers to which time period?

Accepted Answer

The data collected only within the current reporting period

Answer

Interval data covers only the safety information collected during the specific reporting period covered by the current PSUR.

Question 5

Which regulatory agency uses the term 'Periodic Benefit-Risk Evaluation Report' (PBRER) interchangeably with PSUR?

Accepted Answer

EMA (European Medicines Agency)

Answer

The EU/EMA adopted the ICH E2C(R2) format calling it the PBRER, emphasizing the integrated benefit-risk evaluation component.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Periodic Safety Update Reports 3