Regulatory Requirements & ICH Guidelines Flashcards
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Read the first 7 Regulatory Requirements & ICH Guidelines flashcards as text
Under ICH E2A, what is the maximum timeframe for expedited reporting of a fatal or life-threatening unexpected SUSAR from a clinical trial?
Answer: 7 calendar days
ICH E2A requires fatal or life-threatening unexpected SUSARs to be reported within 7 calendar days, with a follow-up report within 8 additional days.
Which ICH guideline specifically addresses the format and content of individual case safety reports (ICSRs) submitted to regulatory authorities?
Answer: ICH E2B
ICH E2B defines the data elements and electronic transmission standards for ICSRs, including the E2B(R3) format based on HL7 ICSR.
A company receives a serious adverse event report from a post-marketing study. Under FDA regulations, within what timeframe must they submit a 15-day Alert Report?
Answer: 15 calendar days from initial receipt
FDA 21 CFR 314.81 requires 15-day Alert Reports for serious, unexpected post-marketing adverse drug reactions to be submitted within 15 calendar days of receipt.
ICH E2E provides guidance on which pharmacovigilance planning activity?
Answer: Pharmacovigilance planning at the time of marketing authorization
ICH E2E guides development of pharmacovigilance plans as part of risk management at the time of marketing authorization application.
Under EU GVP Module VI, which source of adverse event information does NOT typically qualify as a valid spontaneous report?
Answer: A report solicited through a patient support program
Solicited reports from organized data collection programs (e.g., patient support programs) are not considered spontaneous reports and should be handled as study reports.
Which section of the EMA's GVP Modules specifically addresses signal management?
Answer: Module IX
GVP Module IX covers signal management, including detection, validation, prioritization, assessment, and recommendation of regulatory action.
Under ICH E2C(R2), what is the primary purpose of the Development Safety Update Report (DSUR)?
Answer: Annual comprehensive safety review for investigational products in clinical development
The DSUR, defined in ICH E2C(R2), is an annual report summarizing cumulative safety data for investigational medicinal products during clinical development.