Practice Test Geeks(PVC) Pharmacovigilance Certification Practice Test
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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.

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  1. Under 21 CFR Part 314.81, what is the required timeframe for submitting a US IND Annual Report to the FDA?

    Answer: Within 30 days of the IND anniversary date

    The IND Annual Report must be submitted within 60 days of the anniversary of the IND effective date per 21 CFR 312.33.

  2. Which ICH guideline specifically addresses the content and format of the Development Safety Update Report (DSUR)?

    Answer: ICH E2F

    ICH E2F provides guidance on the development, format, and content of the Development Safety Update Report (DSUR).

  3. A marketed drug's PSUR/PBRER covers a data lock point. According to ICH E2C(R2), what is the maximum submission timeline for a PBRER covering a 12-month period?

    Answer: 90 days after the data lock point

    ICH E2C(R2) requires that a PBRER for a 12-month period be submitted within 90 days of the data lock point.

  4. EMA's Good Pharmacovigilance Practices (GVP) Module VI specifies which of the following as a non-serious adverse reaction reporting timeframe for marketed products?

    Answer: Included in periodic reports only

    Under GVP Module VI, non-serious ADRs for marketed products are not individually expedited but are included in periodic safety reports.

  5. Which regulatory framework governs pharmacovigilance obligations for sponsors conducting clinical trials within the European Union?

    Answer: EU Clinical Trials Regulation (EU) No 536/2014

    EU Clinical Trials Regulation (EU) No 536/2014 governs pharmacovigilance and safety reporting for clinical trials conducted in the EU.

  6. Under FDA 21 CFR Part 600.80, what is the expedited reporting requirement for a serious, unexpected adverse experience associated with a biological product?

    Answer: 7 calendar days for fatal/life-threatening; 15 calendar days for other serious unexpected

    For biologics, fatal or life-threatening unexpected AEs require a 7-day alert report; other serious unexpected AEs require a 15-day expedited report.

  7. When the Responsible Person (RP) at an EU marketing authorization holder identifies a signal requiring urgent safety action, which GVP module guides the urgent safety restriction process?

    Answer: GVP Module XVI

    GVP Module XVI specifically covers risk minimization measures, including urgent safety restrictions triggered by new safety signals.