PVC Risk Management & Signal Detection 4

Question 1

Which WHO database is the global reference for spontaneous adverse drug reaction reports used in international signal detection?

Accepted Answer

VigiBase

Answer

VigiBase, maintained by the Uppsala Monitoring Centre (UMC) on behalf of WHO, is the world's largest database of individual case safety reports from over 130 member countries.

Question 2

The 'Information Component' (IC) used by the WHO-UMC is based on which statistical approach?

Accepted Answer

Bayesian confidence propagation neural network

Answer

The IC is derived from a Bayesian Confidence Propagation Neural Network (BCPNN), measuring the statistical association between a drug and an event in VigiBase.

Question 3

A MAH identifies a new serious risk during routine signal detection. According to GVP Module IX, what is the first action the MAH should take?

Accepted Answer

Assess and validate the signal, then notify the competent authority if confirmed

Answer

GVP Module IX requires MAHs to assess and validate detected signals; if the signal is confirmed and may impact the benefit-risk balance, the competent authority must be notified.

Question 4

What is 'missing information' in the context of an EU RMP Safety Specification?

Accepted Answer

Gaps in knowledge about product safety in specific populations or situations not studied

Answer

Missing information refers to areas where safety data are absent or insufficient, such as use in pregnancy, elderly patients, or patients with renal impairment.

Question 5

Which of the following describes a 'Medication Error' in pharmacovigilance classification?

Accepted Answer

An unintended error in prescribing, dispensing, or administration that may or may not cause harm

Answer

A medication error is an unintended failure in the drug treatment process that leads to or has the potential to lead to patient harm, regardless of whether harm actually occurred.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Risk Management & Signal Detection 4