Introduction: Post-approval safety data generation and pharmacovigilance are essential components of drug lifecycle management for B. Pharm students. This topic covers post-marketing surveillance, adverse drug reaction (ADR) reporting, signal detection, risk management plans (RMP), Periodic Safety Update Reports (PSUR/PBRER), post-authorization safety studies (PASS), pharmacoepidemiology, spontaneous reporting systems, data mining (PRR, ROR), MedDRA coding, causality assessment, and regulatory frameworks (ICH, FDA, EMA, PvPI). Understanding these processes helps ensure patient safety, regulatory compliance, and effective benefit–risk assessment. The focus is practical: how safety data are collected, analyzed, communicated, and acted upon to minimize harm. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of post-marketing surveillance in pharmacovigilance?
- To replace clinical trials with marketing campaigns
- To continue monitoring safety and effectiveness after drug approval
- To increase drug sales through promotional events
- To reduce manufacturing costs
Correct Answer: To continue monitoring safety and effectiveness after drug approval
Q2. Which document provides a comprehensive, periodic summary of a drug’s worldwide safety profile?
- Clinical Study Report (CSR)
- Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
- Investigator’s Brochure (IB)
- Certificate of Pharmaceutical Product (CPP)
Correct Answer: Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
Q3. Which of the following is a spontaneous reporting system used to collect individual case safety reports (ICSRs)?
- Randomized controlled trial database
- Vaccine Adverse Event Reporting System (VAERS) and national pharmacovigilance centers
- Pharmaceutical marketing database
- Manufacturing batch records
Correct Answer: Vaccine Adverse Event Reporting System (VAERS) and national pharmacovigilance centers
Q4. What does MedDRA stand for and why is it used?
- Medical Device Regulatory Acts; to regulate devices
- Medical Dictionary for Regulatory Activities; to standardize adverse event coding
- Medicinal Drug Review Agency; to approve medicines
- Medication Documentation and Reporting Application; for prescriptions
Correct Answer: Medical Dictionary for Regulatory Activities; to standardize adverse event coding
Q5. Which method is commonly used for signal detection in large spontaneous reporting databases?
- Randomized clustering
- Disproportionality analysis (e.g., PRR, ROR)
- Single-case qualitative review only
- Manufacturing quality testing
Correct Answer: Disproportionality analysis (e.g., PRR, ROR)
Q6. What is an adverse drug reaction (ADR) as per pharmacovigilance definitions?
- An expected pharmacological effect of a drug
- Any harmful and unintended response to a medicinal product at normal doses
- A manufacturing defect unrelated to patient exposure
- A therapeutic success reported by clinicians
Correct Answer: Any harmful and unintended response to a medicinal product at normal doses
Q7. Which guideline defines requirements for expedited reporting of serious unexpected adverse events from clinical trials?
- ICH E6 (GCP)
- ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting)
- WHO GMP
- ICH Q7
Correct Answer: ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting)
Q8. Which causality assessment method is widely used in pharmacovigilance and relies on a structured questionnaire?
- WHO-UMC system and Naranjo algorithm
- CONSORT checklist
- GMP inspection checklist
- Bharat scoring system
Correct Answer: WHO-UMC system and Naranjo algorithm
Q9. What is the function of a Risk Management Plan (RMP)?
- To outline marketing strategies
- To describe measures for identifying, characterizing, preventing, or minimizing risks associated with a medicinal product
- To list manufacturing suppliers
- To reduce clinical trial sample size
Correct Answer: To describe measures for identifying, characterizing, preventing, or minimizing risks associated with a medicinal product
Q10. Which study type is designed specifically to evaluate safety after a drug has been marketed?
- Phase I clinical trial
- Post-Authorization Safety Study (PASS)
- Preclinical toxicology study
- Bioequivalence study
Correct Answer: Post-Authorization Safety Study (PASS)
Q11. What is the primary role of pharmacoepidemiology in post-marketing safety?
- To develop new drugs
- To study the use and effects of drugs in large populations and evaluate risk factors
- To manufacture pharmaceutical ingredients
- To manage clinical trial sites
Correct Answer: To study the use and effects of drugs in large populations and evaluate risk factors
Q12. Which organization coordinates pharmacovigilance activities in India?
- FDA India
- Pharmacovigilance Programme of India (PvPI)
- European Medicines Agency (EMA)
- World Bank
Correct Answer: Pharmacovigilance Programme of India (PvPI)
Q13. What is an Individual Case Safety Report (ICSR)?
- A manufacturing quality report
- A report documenting a single adverse event associated with a medicinal product
- A marketing expenditure report
- A stability testing report
Correct Answer: A report documenting a single adverse event associated with a medicinal product
Q14. Which term describes an adverse event that is both serious and unexpected?
- Known ADR
- Serious Unexpected Adverse Reaction (SUSAR)
- Non-serious expected event
- Placebo reaction
Correct Answer: Serious Unexpected Adverse Reaction (SUSAR)
Q15. In disproportionality analysis, what does a Reporting Odds Ratio (ROR) >1 suggest?
- No association between drug and event
- A potential signal indicating higher reporting of the event with the drug
- A manufacturing defect
- Guaranteed causality
Correct Answer: A potential signal indicating higher reporting of the event with the drug
Q16. Which regulatory agency maintains the EudraVigilance database?
- US FDA
- European Medicines Agency (EMA)
- Pharmacovigilance Programme of India
- Japanese PMDA only
Correct Answer: European Medicines Agency (EMA)
Q17. What is cohort event monitoring (CEM)?
- A method to monitor manufacturing cohorts
- A prospective observational method to actively follow a defined patient cohort for ADRs
- A technique for randomizing patients
- An advertising cohort study
Correct Answer: A prospective observational method to actively follow a defined patient cohort for ADRs
Q18. Which of the following is an example of an active surveillance method?
- Spontaneous reporting only
- Electronic health record monitoring and cohort event monitoring
- Waiting for voluntary reports
- Manufacturer’s promotional surveys
Correct Answer: Electronic health record monitoring and cohort event monitoring
Q19. What is the purpose of signal validation in pharmacovigilance?
- To increase drug prices
- To confirm whether an observed association is credible and merits further evaluation
- To create advertising material
- To hide adverse events from regulators
Correct Answer: To confirm whether an observed association is credible and merits further evaluation
Q20. Which report is submitted to regulators when an unexpected serious adverse reaction occurs during a clinical trial?
- Annual financial report
- Expedited SUSAR report
- Batch release certificate
- Labeling text
Correct Answer: Expedited SUSAR report
Q21. Which term refers to measures to minimize identified risks of a medicinal product?
- Risk minimization measures (RMM)
- Sales optimization strategies
- Clinical trial recruitment
- Inventory control
Correct Answer: Risk minimization measures (RMM)
Q22. What role do real-world data (RWD) and real-world evidence (RWE) play in post-approval safety?
- They are unrelated to safety monitoring
- They provide observational evidence from routine practice that informs safety and effectiveness
- They replace all randomized trials
- They are used only for pricing decisions
Correct Answer: They provide observational evidence from routine practice that informs safety and effectiveness
Q23. Who is typically responsible for reporting adverse drug reactions to national pharmacovigilance centers?
- Only pharmaceutical salespersons
- Healthcare professionals, patients, and marketing authorization holders
- Only manufacturing technicians
- Only regulatory inspectors
Correct Answer: Healthcare professionals, patients, and marketing authorization holders
Q24. What is the difference between PSUR and PBRER?
- They are totally unrelated documents
- PBRER places greater emphasis on benefit–risk evaluation and integrates global data; PSUR is an older format focused on safety updates
- PSUR is used only in preclinical studies
- PBRER is only for devices
Correct Answer: PBRER places greater emphasis on benefit–risk evaluation and integrates global data; PSUR is an older format focused on safety updates
Q25. Which coding practice ensures harmonized classification of medical terms in ICSRs?
- Random text entries
- Use of MedDRA preferred terms and system organ classes
- Local slang terms
- Only ICD-10 codes for all fields
Correct Answer: Use of MedDRA preferred terms and system organ classes
Q26. What is the significance of seriousness criteria in ADR reporting?
- It determines marketing tactics
- It defines whether an event is life-threatening, requires hospitalization, causes disability, or is fatal, affecting reporting timelines
- It is used to set drug prices
- It is used only for manufacturing quality
Correct Answer: It defines whether an event is life-threatening, requires hospitalization, causes disability, or is fatal, affecting reporting timelines
Q27. Which analytical approach assesses temporal relationships and background rates in pharmacoepidemiology?
- Case series without denominators
- Observed-versus-expected analysis and incidence rate comparisons
- Marketing share analysis
- Laboratory stability tests
Correct Answer: Observed-versus-expected analysis and incidence rate comparisons
Q28. What is a benefit–risk assessment in the context of pharmacovigilance?
- An assessment of manufacturing costs versus sales
- A systematic evaluation of therapeutic benefits compared to safety risks for a medicinal product
- A marketing SWOT analysis
- An environmental impact report
Correct Answer: A systematic evaluation of therapeutic benefits compared to safety risks for a medicinal product
Q29. Which international guideline focuses specifically on periodic benefit–risk evaluation and PSUR format?
- ICH E2C(R2)
- ICH Q9
- WHO GMP Annex 1
- ICH M4
Correct Answer: ICH E2C(R2)
Q30. What is the first step in the signal management process?
- Regulatory enforcement action
- Signal detection (identification of a potential safety issue)
- Product withdrawal without assessment
- Immediate changes to labeling without data review
Correct Answer: Signal detection (identification of a potential safety issue)
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com