Regulatory Requirements & ICH Guidelines 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 Regulatory Requirements & ICH Guidelines flashcards as text
Under ICH E2F, which type of safety report is specifically designed for products studied in non-interventional post-approval safety studies (PASS)?
Answer: Final Study Report following ICH E3 format
ICH E2F provides guidance on preparing final study reports for post-approval non-interventional studies, following ICH E3 clinical study report format adapted for observational research.
The FDA's Sentinel System primarily uses which type of data infrastructure to conduct active post-market safety surveillance?
Answer: Electronic health records and claims data from distributed data partners
Sentinel uses a distributed data network model where partners (insurers, health systems) run queries locally on EHR and claims data without sharing patient-level data centrally.
Under GVP Module V, a Risk Management Plan (RMP) must include which of the following as a core component?
Answer: Safety specification summarizing known and potential risks
The RMP safety specification, per GVP Module V, provides a comprehensive summary of the product's known risks, potential risks, and missing information.
According to ICH E2A, which of the following criteria is NOT required to classify an adverse event as a SUSAR?
Answer: The event must be fatal
A SUSAR requires serious + unexpected + reasonable causal relationship — it does not need to be fatal; fatal events are a subset of serious events.
Which MedDRA hierarchy level is used for signal detection and regulatory submission coding of adverse events?
Answer: Preferred Term (PT)
Preferred Terms (PTs) are the primary level used for ICSR coding, signal detection, and regulatory reporting within the MedDRA hierarchy.
A MAH in the US receives an adverse event report lacking a patient identifier and a reporter. Under FDA guidance, how should this case be handled?
Answer: Processed as a valid report if at least an identifiable patient OR reporter is present along with a suspect drug and adverse event
FDA requires four minimum criteria for a valid ICSR: identifiable patient, identifiable reporter, suspect drug, and adverse event — but 'identifiable' can be indirect (e.g., age/sex without name).
Under EU GVP Module XVI, which category of additional risk minimization measures requires evaluation of their effectiveness?
Answer: All additional risk minimization measures including educational materials and controlled access programs
GVP Module XVI requires MAHs to evaluate the effectiveness of all additional risk minimization measures, including educational programs, patient cards, and controlled access programs.