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
In the EU RMP structure, Module SII (Pharmacovigilance Plan) must describe routine pharmacovigilance activities. Which of the following is classified as a ROUTINE activity?
Answer: Spontaneous adverse drug reaction reporting
Spontaneous adverse reaction reporting is a core routine pharmacovigilance activity; registries, PASSs, and drug utilization studies are additional activities.
A pharmaceutical company is submitting a new marketing authorization application in the EU. When must the RMP be submitted relative to the application?
Answer: Simultaneously with the marketing authorization application
The RMP must be submitted together with the marketing authorization application as an integral part of the dossier.
Which document provides the regulatory framework for RMPs in the European Union?
Answer: Directive 2001/83/EC as amended by Directive 2010/84/EU
EU Directive 2001/83/EC as amended by 2010/84/EU established the legal requirement for risk management systems including RMPs in the EU.
During a CHMP assessment of an RMP, the committee requests that a MAH upgrade a safety concern from 'potential risk' to 'identified risk.' What evidence would MOST justify this reclassification?
Answer: Meta-analysis of multiple trials demonstrating statistically significant causal association
Reclassification to 'identified risk' requires robust evidence of causality, such as that provided by a meta-analysis showing a statistically significant association.
In the context of pediatric risk management, what specific obligation does the EU Pediatric Regulation (EC No 1901/2006) impose on MAHs?
Answer: MAHs must submit a Pediatric Investigation Plan (PIP) as part of the development program
EU Pediatric Regulation requires MAHs to submit and agree on a PIP that outlines how the product will be studied in children, which informs the RMP's missing information and study sections.
When a company discovers that an aRMM (e.g., a checklist for prescribers) is not being consistently used, what is the MOST appropriate first step?
Answer: Investigate root cause and consider targeted improvements or regulatory discussion
If effectiveness evaluation shows an aRMM is underperforming, the MAH should investigate root causes and, if needed, discuss improvements with the regulatory authority.
Which of the following BEST characterizes the 'missing information' section of the Safety Specification in an RMP?
Answer: Population groups or safety aspects not adequately studied or characterized at the time of application
Missing information refers to gaps in safety knowledge for specific populations (e.g., elderly, pregnant women) or conditions not yet characterized in available data.