Practice Test Geeks(PVC) Pharmacovigilance Certification Practice Test
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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.

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  1. Which ICH guideline specifically addresses pharmacovigilance for biotechnology-derived products and establishes principles for immunogenicity assessment?

    Answer: ICH S6(R1)

    ICH S6(R1) provides preclinical safety evaluation guidance for biotechnology-derived pharmaceuticals, including immunogenicity risk assessment principles.

  2. Under FDA 21 CFR Part 600, manufacturers of biological products are required to submit biological product deviation (BPD) reports for which type of events?

    Answer: Manufacturing or processing deviations that may affect safety, purity, or potency

    BPD reports under 21 CFR 600.14 are required for deviations in manufacturing, holding, testing, labeling, or distribution that may affect a biological product's safety, purity, or potency.

  3. The International Birth Defects Information Systems (IBIS) and pregnancy registries in pharmacovigilance primarily serve what purpose?

    Answer: Detecting teratogenic signals through prospective and retrospective collection of pregnancy outcome data

    Pregnancy registries prospectively enroll pregnant women exposed to a drug to detect teratogenic and other pregnancy-related safety signals through systematic outcome collection.

  4. Under EU Regulation 536/2014 (Clinical Trials Regulation), which database serves as the single EU portal for clinical trial information and safety reporting?

    Answer: CTIS (Clinical Trials Information System)

    The Clinical Trials Information System (CTIS) is the EU portal and database established under EU CTR 536/2014 for submission and management of clinical trial applications and safety reporting.

  5. A pharmacovigilance auditor finds that a company's SUSAR reporting timelines were consistently met, but narrative quality was poor. Under GVP Module I, this finding most directly impacts which obligation?

    Answer: Completeness and quality standards for ICSRs required under pharmacovigilance system obligations

    GVP Module I requires that pharmacovigilance systems ensure complete and high-quality ICSRs; poor narrative quality is a compliance gap even when timelines are met.

  6. Which provision of the FDA Safety and Innovation Act (FDASIA 2012) strengthened FDA's authority to require post-market safety studies or clinical trials?

    Answer: Section 505(o)(3) of the FD&C Act

    Section 505(o)(3) of the FD&C Act, as strengthened by FDASIA, gives FDA authority to require post-approval studies or clinical trials to assess known serious risks or new safety signals.

  7. Under GVP Module VII, which of the following is a core requirement for the Periodic Safety Update Report (PSUR) summary tabulations?

    Answer: Patient exposure must be expressed in patient-years using the DDD method where possible

    GVP Module VII requires exposure data to be expressed in patient-years, using defined daily dose (DDD) methodology where applicable, to enable meaningful risk contextualization.