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 MAH is designing a healthcare professional (HCP) educational program as an additional risk minimization measure. Which metric best evaluates its effectiveness?
Answer: Proportion of HCPs who can correctly identify contraindications post-training
Effectiveness of educational aRMMs is best measured by behavioral or knowledge outcomes in the target population, not just material distribution.
In the context of a Risk Management Plan, what is a 'study of concern' under the pharmacovigilance plan module?
Answer: A post-authorization study designed to address a specific safety concern in the RMP
Studies of concern are post-authorization studies specifically designed and required to address important safety uncertainties identified in the RMP.
Which of the following is TRUE regarding the relationship between an RMP and a PSUR?
Answer: PSUR findings can trigger RMP updates if new risks or benefit-risk changes are identified
PSURs evaluate the benefit-risk profile periodically, and significant new findings should prompt an RMP review and update if warranted.
A pregnancy prevention program (PPP) is a classic example of which type of risk minimization measure?
Answer: Additional risk minimization measure (aRMM)
Pregnancy prevention programs are additional risk minimization measures that impose structured requirements beyond standard labeling to prevent teratogenic exposure.
When preparing the 'Summary of Safety Concerns' in Module SI of the EU RMP, which category should NOT be listed as an important identified risk?
Answer: Theoretical interaction based on mechanism of action only
A purely theoretical mechanism-based concern with no clinical evidence belongs in 'important potential risk' or 'missing information,' not as an identified risk.
In the US FDA risk management context, what is the primary regulatory framework that may require a Risk Evaluation and Mitigation Strategy (REMS)?
Answer: FDAAA 2007 (Food and Drug Administration Amendments Act)
FDAAA 2007 granted FDA authority to require REMS programs when necessary to ensure a drug's benefits outweigh its risks.
Which element is REQUIRED in every REMS program, regardless of the level of risk?
Answer: A timetable for assessments of the REMS
FDA requires every REMS to include a timetable for periodic assessments to evaluate whether it is meeting its goals.