Risk Management & Signal Detection 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 Risk Management & Signal Detection flashcards as text
What is the key difference between a 'signal' and a 'confirmed safety concern' in pharmacovigilance?
Answer: A signal is an unverified hypothesis of a drug-event association; a confirmed concern has sufficient evidence to require action
A signal is a hypothesis generated from data suggesting a possible association, while a confirmed safety concern has been evaluated and found to represent a genuine drug-related risk requiring regulatory action.
Which of the following is a characteristic feature of 'notoriety bias' in spontaneous reporting?
Answer: Surge in reporting of a drug-event pair following media publicity, independent of actual risk change
Notoriety bias (also called stimulated reporting) occurs when media coverage or public attention causes a temporary spike in reports for a specific drug-event pair.
Under ICH E2E, the 'Pharmacovigilance Plan' section of an RMP should prioritize activities based on:
Answer: The importance and frequency of identified risks and the adequacy of existing data
ICH E2E requires that pharmacovigilance activities be prioritized according to the significance of each safety concern and the existing gaps in knowledge.
A company's signal detection process reviews spontaneous reports every month. This frequency is best described as:
Answer: Periodic signal detection
Reviewing spontaneous reports at fixed, regular intervals (e.g., monthly) is classified as periodic signal detection.
Which of the following best illustrates an 'Important Identified Risk' suitable for inclusion in Part II of an EU RMP?
Answer: Drug-induced QT prolongation confirmed by clinical trial electrocardiogram data
An Important Identified Risk is one where evidence of a causal association with the drug is established; QT prolongation confirmed by ECG data in clinical trials meets this standard.
What is the role of the PRAC (Pharmacovigilance Risk Assessment Committee) in the EU signal management process?
Answer: It evaluates signals referred by EMA or NCAs and recommends regulatory action to CHMP
PRAC is the EMA committee responsible for assessing and monitoring the safety of human medicines, including evaluating safety signals and recommending risk minimization measures to CHMP.
A pharmaceutical company updates its REMS program to add a new patient medication guide. Which FDA office must review and approve this change before implementation?
Answer: The relevant review division within CDER or CBER
REMS modifications, including additions like patient medication guides, must be submitted to and approved by the FDA review division responsible for that specific product within CDER or CBER.