Periodic Safety Update Reports 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 Periodic Safety Update Reports flashcards as text
What is the International Birth Date (IBD) of a medicinal product used in PSUR scheduling?
Answer: The date the product received its first marketing authorization anywhere in the world
The IBD is the date of first marketing authorization for a medicinal product anywhere in the world, which anchors the PSUR submission schedule.
In ICH E2C(R2), what does the 'data lock point' (DLP) refer to in a PSUR?
Answer: The date after which no new safety data is included in the current PSUR
The data lock point is the cut-off date for including safety data in a PSUR; data received after this date is excluded from the current report.
Which section of the PSUR specifically addresses the benefit-risk evaluation of the product?
Answer: Integrated Benefit-Risk Analysis for Approved Indications
ICH E2C(R2) designates a dedicated Integrated Benefit-Risk Analysis section where the MAH evaluates the overall benefit-risk balance for approved indications.
Under the EU pharmacovigilance legislation (Regulation 726/2004), what is the standard PSUR submission frequency for a product in the first two years post-authorization?
Answer: Every 6 months
EU legislation requires PSURs every 6 months for the first 2 years following initial marketing authorization.
What is a PSUR Single Assessment (PSUSA) in the European context?
Answer: A single EU-coordinated assessment of PSURs for products containing the same active substance
PSUSA is a procedure where EMA coordinates a single harmonized assessment of PSURs for all EU-authorized products sharing the same active substance.
Which of the following best describes the role of the 'Reference Safety Information' (RSI) in a PSUR?
Answer: It serves as the benchmark for classifying adverse events as listed or unlisted
The RSI, typically the Company Core Data Sheet (CCDS) or Company Core Safety Information (CCSI), is the reference document used to determine whether adverse events are listed (expected) or unlisted (unexpected).
When a new significant safety signal is identified during a PSUR reporting interval, what is the MAH typically required to do beyond the PSUR?
Answer: Submit an expedited safety report or urgent safety restriction if warranted
Significant safety signals that pose an immediate risk require expedited reporting or urgent safety restrictions independently of the PSUR schedule.