Pharmacovigilance planning (ICH E2E) MCQs With Answer

Pharmacovigilance planning (ICH E2E) MCQs With Answer
This concise introduction explains pharmacovigilance planning under ICH E2E for B. Pharm students. It covers pharmacovigilance system design, safety data collection, Individual Case Safety Reports (ICSRs), aggregate reporting (PBRER/PSUR), signal detection, risk management plans, benefit–risk assessment, expedited reporting timelines, and regulatory expectations. Emphasis is on practical topics: safety specification, causality assessment, MedDRA coding, data sources, signal management, PV quality systems, and pharmacovigilance planning documents. These focused MCQs deepen understanding for clinical trials, post-marketing surveillance, periodic reporting, and regulatory submissions, preparing students for exams and careers in drug safety. It also highlights global harmonisation and practical examples. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of pharmacovigilance planning as described in ICH E2E?

• To develop marketing strategies for new drugs
• To define and organise safety data collection, analysis and reporting throughout development and post-marketing
• To replace clinical trials with observational studies
• To set drug pricing and reimbursement policies

Correct Answer: To define and organise safety data collection, analysis and reporting throughout development and post-marketing

Q2. Which document focuses on periodic aggregate evaluation of benefit–risk for marketed products?

• DSUR (Development Safety Update Report)
• PBRER (Periodic Benefit–Risk Evaluation Report)
• Clinical Study Report (CSR)
• Investigator’s Brochure (IB)

Correct Answer: PBRER (Periodic Benefit–Risk Evaluation Report)

Q3. Which report is primarily used during clinical development to provide an annual safety summary?

• PSUR
• DSUR
• PBRER
• Periodic Safety Update Report for marketed drugs

Correct Answer: DSUR

Q4. Which of the following is NOT a core element of an Individual Case Safety Report (ICSR)?

• Identifiable patient
• Detailed pharmacoeconomic analysis
• Suspected drug
• Description of adverse event

Correct Answer: Detailed pharmacoeconomic analysis

Q5. In pharmacovigilance planning, what does a “safety specification” typically describe?

• Marketing targets for safety departments
• Identified and potential safety concerns and missing information
• The pricing strategy for safety monitoring systems
• Laboratory procedures for manufacturing

Correct Answer: Identified and potential safety concerns and missing information

Q6. Which terminology system is commonly recommended for coding adverse events in ICSR and aggregate reports?

• ICD-10
• SNOMED CT
• MedDRA
• LOINC

Correct Answer: MedDRA

Q7. Which activity is central to signal detection in pharmacovigilance?

• Manufacturing quality control
• Identifying new or changing adverse event patterns from spontaneous reports and data sources
• Setting drug prices
• Marketing post-approval promotions

Correct Answer: Identifying new or changing adverse event patterns from spontaneous reports and data sources

Q8. Which of these is a common data source used in pharmacovigilance planning for signal generation?

• Spontaneous reporting databases
• Sales team reports
• Manufacturing batch records only
• Advertising metrics

Correct Answer: Spontaneous reporting databases

Q9. What is the WHO-UMC causality category that indicates a reasonable temporal relationship and response to withdrawal, but could also be explained by disease?

• Certain
• Possible
• Unlikely
• Unassessable

Correct Answer: Possible

Q10. Which section of a pharmacovigilance plan defines roles, responsibilities and interfaces with regulatory authorities?

• Data entry manual
• PV governance and organisational responsibilities
• Marketing plan
• Clinical protocol appendices

Correct Answer: PV governance and organisational responsibilities

Q11. Under ICH guidance, what is the purpose of expedited (rapid) reporting?

• To delay release of safety information
• To inform regulators promptly about serious unexpected suspected adverse reactions
• To summarise annual sales
• To communicate manufacturing changes

Correct Answer: To inform regulators promptly about serious unexpected suspected adverse reactions

Q12. Which of the following best describes a “SUSAR” in clinical trial safety reporting?

• Serious and unexpected suspected adverse reaction
• Standardized user safety assessment report
• Systematic unusual safety analysis result
• Summary of urgent statistical adverse risks

Correct Answer: Serious and unexpected suspected adverse reaction

Q13. What is an important objective of a Risk Management Plan (RMP) in pharmacovigilance planning?

• To outline clinical endpoints for efficacy only
• To describe planned pharmacovigilance activities and risk minimisation measures
• To replace individual safety reports
• To manage company finances

Correct Answer: To describe planned pharmacovigilance activities and risk minimisation measures

Q14. Which type of analysis is typically included in aggregate periodic reports like PBRER?

• Benefit–risk evaluation using cumulative safety and efficacy data
• Detailed patient-level billing history
• Marketing campaign effectiveness
• Manufacturing yield statistics

Correct Answer: Benefit–risk evaluation using cumulative safety and efficacy data

Q15. Which ICH document primarily provides recommendations on pharmacovigilance planning across the development lifecycle?

• ICH E2E
• ICH Q9
• ICH M4
• ICH S7

Correct Answer: ICH E2E

Q16. In an ICSR, which element helps determine that an adverse event is unexpected?

• Comparison with the product’s reference safety information
• Comparison with manufacturing specifications
• Comparison with marketing strategy
• Comparison with patient’s insurance details

Correct Answer: Comparison with the product’s reference safety information

Q17. What does proactive signal management include in pharmacovigilance planning?

• Only routine annual safety reporting
• Regular data review, follow-up evaluation and prioritisation of potential signals
• Delaying analysis until post-marketing monopoly
• Focusing solely on efficacy outcomes

Correct Answer: Regular data review, follow-up evaluation and prioritisation of potential signals

Q18. Which of the following best defines an “identified risk” in a safety specification?

• A theoretical hazard never observed in patients
• An adverse reaction observed and causally linked to the medicine
• An unrelated comorbidity
• A manufacturing impurity

Correct Answer: An adverse reaction observed and causally linked to the medicine

Q19. Which regulatory expectation is commonly addressed in PV planning regarding data quality?

• That all safety data are ignored in regulatory submissions
• Appropriate data cleaning, validation, and audit trails to ensure reliable safety information
• That only paper records are accepted
• That marketing teams validate safety data

Correct Answer: Appropriate data cleaning, validation, and audit trails to ensure reliable safety information

Q20. Which is a typical step after a potential safety signal is detected?

• Immediate global withdrawal without assessment
• Signal validation, causality assessment, prioritisation and further evaluation
• Ignore the signal until mandated by marketing
• Publish without internal review

Correct Answer: Signal validation, causality assessment, prioritisation and further evaluation

Q21. What does “missing information” in a safety specification usually refer to?

• Known risks that require no further data
• Areas where knowledge is limited, such as use in pregnancy or in certain age groups
• Marketing gaps in promoted regions
• Manufacturing documentation errors

Correct Answer: Areas where knowledge is limited, such as use in pregnancy or in certain age groups

Q22. Which stakeholder is typically responsible for submitting regulatory safety reports according to the PV plan?

• The clinical trial investigator only
• The marketing team exclusively
• The marketing authorisation holder or sponsor
• Patients directly

Correct Answer: The marketing authorisation holder or sponsor

Q23. Which assessment helps determine whether an individual adverse event is likely related to a drug?

• Causality assessment
• Financial risk assessment
• Market analysis
• Quality by design assessment

Correct Answer: Causality assessment

Q24. What is the role of periodic aggregate safety reports in regulatory decision-making?

• They are used to assess cumulative safety and support benefit–risk decisions
• They are primarily used for advertising approvals
• They are only for internal finance teams
• They replace the need for ongoing adverse event reporting

Correct Answer: They are used to assess cumulative safety and support benefit–risk decisions

Q25. Which is NOT a common method for signal detection?

• Disproportionality analysis of spontaneous reports
• Routine review of clinical trial safety data
• Analysis of electronic health records and registries
• Hearsay from non-verified marketing sources

Correct Answer: Hearsay from non-verified marketing sources

Q26. In PV planning, why is global harmonisation important?

• To ensure consistent safety monitoring and reporting practices across regions
• To harmonise manufacturing batch sizes
• To unify marketing messages
• To synchronise sales incentives

Correct Answer: To ensure consistent safety monitoring and reporting practices across regions

Q27. Which ICH document series deals with clinical safety data management and aggregate reporting?

• ICH Q series
• ICH E series
• ICH M series
• ICH S series

Correct Answer: ICH E series

Q28. What is a key consideration when designing a pharmacovigilance plan for a paediatric population?

• No additional considerations are required
• Specific safety concerns, dosing differences, and data collection tailored to children
• Only marketing materials need adaptation
• Exclude paediatric data from aggregate reports

Correct Answer: Specific safety concerns, dosing differences, and data collection tailored to children

Q29. Which activity ensures that spontaneous adverse event reports are consistently interpreted?

• Random data deletion
• Use of standardised coding (e.g., MedDRA) and documented case assessment procedures
• Relying solely on free-text descriptions
• Outsourcing interpretation to sales colleagues

Correct Answer: Use of standardised coding (e.g., MedDRA) and documented case assessment procedures

Q30. What is the value of including practical examples and scenarios in pharmacovigilance planning education for B. Pharm students?

• They distract from core theory
• They help apply concepts to real-world safety assessment, reporting and decision-making
• They increase marketing appeal only
• They replace the need for regulatory knowledge

Correct Answer: They help apply concepts to real-world safety assessment, reporting and decision-making

Download