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
Under EU GVP Module VII, what is the primary purpose of the Risk Management Plan (RMP)?
Answer: To describe the safety profile and outline measures to prevent or minimize risks
The RMP describes a product's safety profile, pharmacovigilance plan, and risk minimization measures to prevent or reduce risks.
The MedWatch 3500A form is used by whom for mandatory reporting of serious adverse events to the FDA?
Answer: Manufacturers, importers, and device user facilities for mandatory reporting
Form FDA 3500A is the mandatory reporting form used by manufacturers, importers, and device user facilities for serious adverse events.
Which section of the Code of Federal Regulations requires manufacturers to submit Field Alert Reports (FARs) for drug products?
Answer: 21 CFR 314.81(b)(1)
21 CFR 314.81(b)(1) requires NDA holders to submit Field Alert Reports within 3 working days for certain product quality concerns.
Under ICH E2A, a 'suspected unexpected serious adverse reaction' (SUSAR) in a clinical trial must be reported to the FDA within how many calendar days if it is life-threatening?
Answer: 7 calendar days
ICH E2A requires that fatal or life-threatening SUSARs be reported to the regulatory authority within 7 calendar days.
What does the term 'Reference Safety Information (RSI)' refer to in the context of pharmacovigilance reporting?
Answer: The safety information used to assess expectedness of adverse reactions, typically the IB or SmPC
RSI is the safety document (Investigator's Brochure or core data sheet/SmPC) used to determine whether an adverse reaction is expected or unexpected.
According to GVP Module VI, which of the following is a minimum criterion required to consider a case report valid for expedited reporting?
Answer: An identifiable patient, identifiable reporter, a suspect product, and an adverse event
The four minimum criteria for a valid ICSR are: an identifiable patient, an identifiable reporter, a suspect medicinal product, and an adverse event.
Japan's PMDA requires initial reporting of unexpected serious adverse drug reactions from clinical trials within which timeframe?
Answer: 7 days for fatal/life-threatening; 15 days for other serious unexpected
PMDA requires 7-day reporting for fatal or life-threatening unexpected serious ADRs and 15-day reporting for other unexpected serious ADRs in clinical trials.