PVC Regulatory Requirements & ICH Guidelines 3

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?

Accepted Answer

15 calendar days

Answer

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?

Accepted Answer

Reference Safety Information (RSI) or current labeling

Answer

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?

Accepted Answer

ICH E2C(R2)

Answer

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?

Accepted Answer

FDA Form 3500

Answer

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?

Accepted Answer

Every 3 years unless otherwise specified in the EURD list

Answer

The EMA's EURD (European Union Reference Dates) list specifies submission frequency; products without ongoing concerns typically move to 3-year cycles.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Regulatory Requirements & ICH Guidelines 3