Periodic Safety Update Reports Flashcards
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Read the first 7 Periodic Safety Update Reports flashcards as text
Which ICH guideline specifically governs the structure and content of Periodic Safety Update Reports?
Answer: ICH E2C(R2)
ICH E2C(R2) provides the current harmonized guideline for PSUR/PBRER content, format, and principles for marketed products.
A marketing authorization holder (MAH) discovers a new contraindication during a PSUR review period. Where in the PSUR should this primarily be addressed?
Answer: Signal and Risk Evaluation section and the Integrated Benefit-Risk Analysis
New contraindications are analyzed in the Signal and Risk Evaluation section and must be reflected in the Integrated Benefit-Risk Analysis with proposed regulatory actions.
What is the typical timeline for submitting a PSUR to the EMA after the data lock point?
Answer: 70 calendar days
EU regulations require MAHs to submit PSURs within 70 calendar days of the data lock point.
In a PSUR, how should an adverse event that is listed in the RSI but occurs at a higher-than-expected frequency be characterized?
Answer: It remains listed but may represent an emerging signal requiring evaluation
Increased reporting frequency of a listed event can constitute a signal even if the event itself is expected, requiring evaluation in the signal section.
Which of the following sources of data is typically NOT included in the patient exposure estimate within a PSUR?
Answer: Number of patients who did not tolerate the drug and discontinued
Patients who discontinued therapy are still part of the exposed population; they are not excluded from exposure estimates.
What does 'enhanced pharmacovigilance' during a PSUR period typically mean for the MAH?
Answer: Conducting additional studies, closer monitoring, or patient registries as required by regulators
Enhanced pharmacovigilance involves additional risk minimization or monitoring measures such as PASS studies, registries, or more frequent PSUR submissions.
When regulatory authorities request an ad-hoc or triggered PSUR, what typically prompts such a request?
Answer: An emerging safety signal or a public health concern identified outside the routine schedule
Ad-hoc PSURs are requested when a new safety signal, major labeling change, or urgent public health issue requires an out-of-cycle benefit-risk assessment.