PVC Risk Management & Signal Detection 2

Question 1

Which regulatory framework requires a Risk Management Plan (RMP) to be submitted alongside a Marketing Authorization Application in the EU?

Accepted Answer

EU GVP Module V

Answer

EU GVP Module V governs Risk Management Systems and mandates an RMP for new MAAs in the European Union.

Question 2

What is the minimum disproportionality threshold commonly used with the Reporting Odds Ratio (ROR) to flag a potential signal?

Accepted Answer

ROR > 1.0 with 95% CI lower bound > 1

Answer

A signal is typically flagged when the ROR exceeds 1.0 and the lower bound of the 95% confidence interval is also above 1.

Question 3

In signal management, what does the term 'signal validation' refer to?

Accepted Answer

Assessing whether data support a causal association beyond background noise

Answer

Signal validation evaluates whether the available data provide sufficient evidence that the detected association is more than a statistical artifact.

Question 4

A Risk Minimization Measure (RMM) that restricts prescribing to certified specialists is classified as:

Accepted Answer

Additional RMM — restricted access

Answer

Restricted access programs, such as prescriber certification requirements, are categorized as additional RMMs that control who can prescribe or dispense a medicine.

Question 5

Which metric does the Proportional Reporting Ratio (PRR) compare?

Accepted Answer

Proportion of reports for a drug-event pair vs. all reports for that event across all drugs

Answer

The PRR compares the proportion of reports for a specific drug-event combination to the proportion of the same event reported for all other drugs in the database.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Risk Management & Signal Detection 2