PVC Regulatory Requirements & ICH Guidelines 3 — Questions and Answers
Question 1: Under 21 CFR 312.32, a sponsor must notify FDA of an IND safety report for an unexpected serious adverse reaction within what timeframe?
- 15 calendar days (Correct answer)
- 7 calendar days
- 30 calendar days
- 24 hours
Correct answer: 15 calendar days
Under 21 CFR 312.32(c)(1), sponsors must report unexpected serious adverse reactions that suggest significant risk within 15 calendar days.
Question 2: The concept of 'expectedness' in pharmacovigilance is determined by comparing an adverse event to which reference document?
- Reference Safety Information (RSI) or current labeling (Correct answer)
- ICH E2A guideline definitions
- MedDRA lowest-level term dictionary
- WHO-UMC causality criteria
Correct answer: Reference Safety Information (RSI) or current labeling
Expectedness is assessed against the Reference Safety Information (RSI), which for marketed products is typically the current approved labeling (e.g., SmPC or USPI).
Question 3: Which ICH guideline introduced the concept of the Periodic Benefit-Risk Evaluation Report (PBRER) to replace the traditional PSUR?
- ICH E2C(R2) (Correct answer)
- ICH E2D
- ICH E2F
- ICH E2E
Correct answer: ICH E2C(R2)
ICH E2C(R2) replaced the earlier E2C(R1) PSUR format with the PBRER, which requires an integrated benefit-risk evaluation as a core component.
Question 4: Under FDA's MedWatch program, which form is used by consumers and healthcare professionals to voluntarily report adverse events for marketed drugs?
- FDA Form 3500 (Correct answer)
- FDA Form 3500A
- FDA Form 356h
- FDA Form 1571
Correct answer: FDA Form 3500
FDA Form 3500 is the voluntary MedWatch reporting form for consumers and healthcare professionals, while Form 3500A is the mandatory version for industry.
Question 5: A pharmaceutical company must submit a PSUR/PBRER to the EMA at what frequency for a product that has been on the market for 3 years without safety concerns?
- Every 3 years unless otherwise specified in the EURD list (Correct answer)
- Every 6 months regardless of time on market
- Annually for the first 5 years post-approval
- Only when a safety signal is detected
Correct answer: Every 3 years unless otherwise specified in the EURD list
The EMA's EURD (European Union Reference Dates) list specifies submission frequency; products without ongoing concerns typically move to 3-year cycles.
Question 6: According to GVP Module I, what is the primary objective of a pharmacovigilance system master file (PSMF)?
- To describe the pharmacovigilance system and demonstrate compliance with EU GVP obligations (Correct answer)
- To document all individual case safety reports received by a MAH
- To outline the risk management plan for each authorized product
- To record signal detection activities and outcomes
Correct answer: To describe the pharmacovigilance system and demonstrate compliance with EU GVP obligations
The PSMF is a detailed description of the pharmacovigilance system used by an MAH, required to demonstrate that the system meets EU regulatory requirements.
Question 7: Which regulatory framework requires a Qualified Person for Pharmacovigilance (QPPV) to be based in the European Union?
- EU Directive 2001/83/EC as amended by Directive 2010/84/EU (Correct answer)
- ICH E2E guideline
- FDA 21 CFR Part 314
- WHO pharmacovigilance indicators
Correct answer: EU Directive 2001/83/EC as amended by Directive 2010/84/EU
EU Directive 2001/83/EC (amended by 2010/84/EU) mandates that marketing authorization holders designate a QPPV permanently and continuously available in the EU.
PVC Regulatory Requirements & ICH Guidelines 3
Under 21 CFR 312.32, a sponsor must notify FDA of an IND safety report for an unexpected serious adverse reaction within what timeframe?