PVC Risk Management & Signal Detection

Question 1

What is the primary goal of a Risk Management Plan (RMP) in pharmacovigilance?

Accepted Answer

Identify and manage drug safety risks

Answer

Ensure marketing authorization renewal

Answer

Monitor market competition

Answer

Increase drug sales

Question 2

Which of the following is considered a quantitative method for signal detection?

Accepted Answer

Proportional Reporting Ratio (PRR)

Answer

Root cause analysis

Answer

SWOT analysis

Answer

Literature review

Question 3

Which organization provides guidance on signal management in the EU?

Accepted Answer

EMA

Answer

FDA

Answer

CDC

Answer

WHO

Question 4

What is a signal in pharmacovigilance?

Accepted Answer

Potential association needing further review

Answer

Confirmed adverse reaction

Answer

Marketing report

Answer

Sales trend anomaly

Question 5

What document is submitted to summarize identified risks, potential risks, and missing information?

Accepted Answer

RMP

Answer

PSUR

Answer

IB

Answer

CSR

Question 6

Which of the following is an example of a risk minimization measure?

Accepted Answer

Educational materials for prescribers

Answer

Sales forecasting

Answer

Pricing strategy report

Answer

Annual marketing plan