PVC Regulatory Guidelines & Compliance 3 — Questions and Answers
Question 1: Under EU GVP Module VII, what is the primary purpose of the Risk Management Plan (RMP)?
- To summarize all adverse events reported during clinical trials
- To describe the safety profile and outline measures to prevent or minimize risks (Correct answer)
- To replace the PSUR for post-authorization reporting
- To document all pharmacokinetic data for a product
Correct 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.
Question 2: The MedWatch 3500A form is used by whom for mandatory reporting of serious adverse events to the FDA?
- Patients and consumers only
- Healthcare professionals for voluntary reporting
- Manufacturers, importers, and device user facilities for mandatory reporting (Correct answer)
- Insurance companies for billing purposes
Correct 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.
Question 3: Which section of the Code of Federal Regulations requires manufacturers to submit Field Alert Reports (FARs) for drug products?
- 21 CFR 310.305
- 21 CFR 314.81(b)(1) (Correct answer)
- 21 CFR 600.80
- 21 CFR 312.32
Correct 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.
Question 4: 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?
- 15 calendar days
- 7 calendar days (Correct answer)
- 3 calendar days
- 30 calendar days
Correct answer: 7 calendar days
ICH E2A requires that fatal or life-threatening SUSARs be reported to the regulatory authority within 7 calendar days.
Question 5: What does the term 'Reference Safety Information (RSI)' refer to in the context of pharmacovigilance reporting?
- The list of all marketed formulations of a product
- The safety information used to assess expectedness of adverse reactions, typically the IB or SmPC (Correct answer)
- The FDA's list of approved indications for a drug
- The database of spontaneous reports used as a reference benchmark
Correct 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.
Question 6: According to GVP Module VI, which of the following is a minimum criterion required to consider a case report valid for expedited reporting?
- An identifiable patient, identifiable reporter, a suspect product, and an adverse event (Correct answer)
- A confirmed diagnosis, lab results, patient name, and prescribing physician
- A serious outcome, causality assessment, and product batch number
- A MedDRA code, narrative, and patient age
Correct 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.
Question 7: Japan's PMDA requires initial reporting of unexpected serious adverse drug reactions from clinical trials within which timeframe?
- 7 days for fatal/life-threatening; 15 days for other serious unexpected (Correct answer)
- 15 days for all serious unexpected
- 30 days for all serious unexpected
- 3 days for fatal; 7 days for others
Correct 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.
PVC Regulatory Guidelines & Compliance 3
Under EU GVP Module VII, what is the primary purpose of the Risk Management Plan (RMP)?