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
Which ICH guideline specifically addresses the development and implementation of Risk Management Plans (RMPs)?
Answer: ICH E2E
ICH E2E (Pharmacovigilance Planning) provides guidance on pharmacovigilance planning including the development of RMPs.
What is the primary purpose of a Pharmacovigilance System Master File (PSMF) in relation to risk management?
Answer: To describe the pharmacovigilance system and demonstrate its adequacy
The PSMF describes the pharmacovigilance system used by the MAH and demonstrates it meets regulatory requirements, supporting overall risk management.
In an EU Risk Management Plan, which module specifically addresses the 'missing information' category of safety concerns?
Answer: Module SI — Safety Specification
Module SI of the EU RMP Safety Specification includes the 'Missing Information' section that identifies gaps in safety knowledge.
A company identifies a new signal for a product already on the market. Which action within risk management planning is MOST immediately required?
Answer: Evaluate the signal and determine if RMP update is warranted
Signal evaluation is required first; if the signal is validated and changes the benefit-risk profile, the RMP must be updated accordingly.
What distinguishes an 'important identified risk' from an 'important potential risk' in pharmacovigilance?
Answer: Identified risks have sufficient evidence of a causal association; potential risks have limited evidence
Important identified risks have established evidence of causal association, while important potential risks are suspected but lack conclusive evidence.
Which tool is considered an ADDITIONAL risk minimization measure (aRMM) as opposed to a routine one?
Answer: Controlled distribution program
Controlled distribution programs restrict prescribing or dispensing to specific settings or patients, making them additional rather than routine measures.
Under EU GVP Module V, how often must a MAH submit an RMP update in the absence of a specific regulatory request?
Answer: When a new safety concern is identified or when the benefit-risk profile changes
RMP updates are triggered by new safety concerns, changes in benefit-risk profile, or at defined lifecycle milestones, not on a fixed annual schedule.