PVC Risk Management & Signal Detection 3

Question 1

In the context of signal detection, what is a 'false positive' signal?

Accepted Answer

A statistical association that does not reflect a true causal relationship

Answer

A false positive is a statistical disproportionality that meets detection thresholds but does not represent a real drug-caused effect upon further evaluation.

Question 2

Which of the following best describes the concept of 'Important Potential Risk' in an EU RMP?

Accepted Answer

An unconfirmed concern based on preclinical data, mechanism, or class effects that may be causal

Answer

An Important Potential Risk is a concern for which there is some evidence of association but causality has not been confirmed.

Question 3

The Empirical Bayes Geometric Mean (EBGM) is primarily used in which signal detection system?

Accepted Answer

FDA FAERS (Multi-item Gamma Poisson Shrinker — MGPS)

Answer

The FDA uses the Multi-item Gamma Poisson Shrinker (MGPS), which outputs the EBGM as its primary disproportionality statistic in FAERS analyses.

Question 4

Which element of a Risk Management Plan specifically describes what is already known about the drug's safety profile at the time of authorization?

Accepted Answer

Safety Specification

Answer

The Safety Specification summarizes known and potential risks, populations at risk, missing information, and the epidemiology of the condition.

Question 5

A product is withdrawn from the EU market due to an unfavorable benefit-risk balance. Which authority issues the withdrawal decision for centrally authorized products?

Accepted Answer

CHMP via the European Commission

Answer

For centrally authorized products, the CHMP issues an opinion and the European Commission issues the formal legal decision to suspend or withdraw the marketing authorization.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Risk Management & Signal Detection 3