Risk Management Planning 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 Planning flashcards as text
A company has identified 'use in lactating women' as missing information in its RMP. What is the MOST appropriate pharmacovigilance activity to address this gap?
Answer: Conduct a post-authorization safety study (PASS) in lactating women
A PASS specifically designed to collect data in lactating women is the appropriate method to characterize and address this safety data gap.
What does 'proportionality' mean in the context of designing risk minimization measures?
Answer: Measures should be commensurate with the nature and severity of the risk
Proportionality requires that risk minimization measures be scaled to match the seriousness, frequency, and reversibility of the risk being managed.
Under GVP Module XVI, what is the minimum assessment frequency specified for an aRMM implemented after initial approval?
Answer: As agreed with the regulatory authority, typically at 12 and 18 months then at renewal
GVP Module XVI recommends aRMM effectiveness assessments at 12 months, 18 months, and at license renewal unless regulators specify different milestones.
Which statement BEST describes the role of the Qualified Person for Pharmacovigilance (QPPV) in risk management planning?
Answer: The QPPV has overall responsibility for the pharmacovigilance system including RMP oversight
The QPPV bears overall responsibility for the pharmacovigilance system, which includes ensuring RMPs are developed, maintained, and submitted appropriately.
When a generic product seeks marketing authorization, under what circumstances is a full standalone RMP required?
Answer: When the reference product has an RMP and the generic has additional or different safety concerns
Generics typically follow the reference product's RMP, but a standalone or adapted RMP is needed if additional safety concerns exist that differ from the reference product.
A company receives a health authority request to evaluate whether a risk minimization measure is achieving its intended objective. This is known as:
Answer: A risk minimization measure effectiveness evaluation
Risk minimization measure effectiveness evaluation (or aRMM evaluation) assesses whether implemented measures are achieving their stated goals.
In risk management planning, what is the concept of 'benefit-risk balance' intended to assess?
Answer: Whether the positive therapeutic effects outweigh the risks in the target population
Benefit-risk balance evaluation determines whether the clinical benefits of a medicine in its indicated population outweigh the known and potential risks.