Regulatory Guidelines & Compliance 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 Guidelines & Compliance flashcards as text
ICH E2B(R3) specifies a standard for electronic transmission of individual case safety reports (ICSRs). Which technical format does it use?
Answer: HL7 ICSR message using ISO/HL7 21090 data types
ICH E2B(R3) uses an HL7 ICSR message format with ISO/HL7 21090 data types for electronic transmission of individual case safety reports.
A company receives a report of a serious adverse event from a patient advocacy group's social media post. Under GVP Module VI, is this considered a valid ICSR?
Answer: Yes, if the four minimum criteria are identifiable from the information provided
Social media reports can constitute valid ICSRs if the four minimum criteria (identifiable patient, reporter, suspect product, adverse event) can be identified from the available information.
Which US regulation requires manufacturers of OTC drug products marketed without an approved NDA to report adverse events to the FDA?
Answer: 21 CFR 310.305
21 CFR 310.305 requires manufacturers, packers, and distributors of marketed prescription and OTC drugs without an approved NDA to submit adverse drug experience reports to FDA.
Under EU GVP Module V, what is the primary risk characterization tool that MAHs must use to systematically evaluate potential and identified risks?
Answer: Risk Management Plan (RMP) safety specification
The RMP safety specification, as described in GVP Module V, is the primary structured tool for characterizing the known and potential risks of a medicinal product.
A sponsor receives a fatal SUSAR from an investigator site in Canada for a drug under a US IND. What is the correct regulatory action?
Answer: Submit a 7-day alert report to FDA and notify all investigators via IND Safety Report within 15 days
Under 21 CFR 312.32, fatal SUSARs anywhere in the world trigger a 7-day alert to FDA, followed by a full 15-day expedited report and notification to all investigators.
Which of the following best describes the concept of 'aggregate signal detection' under GVP Module IX?
Answer: Identifying new safety information from cumulative data across multiple sources including literature, registries, and spontaneous reports
Aggregate signal detection involves systematic review of cumulative data from spontaneous reports, clinical trials, literature, registries, and other sources to identify new safety signals.
What is the primary difference between a 'Direct Healthcare Professional Communication' (DHPC) and a standard product label update in EU pharmacovigilance?
Answer: A DHPC is sent proactively to prescribers when an urgent safety issue requires immediate communication, while label updates follow normal variation procedures
A DHPC is a direct, urgent communication sent proactively to healthcare professionals to inform them of important new safety information, while SmPC updates follow regulatory variation timelines.