PVC Regulatory Guidelines & Compliance

Question 1

Which international guideline provides standards for the collection and reporting of adverse drug reactions?

Accepted Answer

ICH E2A

Answer

ICH E6

Answer

ICH M4

Answer

FDA CFR Part 11

Question 2

What is the purpose of Good Pharmacovigilance Practices (GVP)?

Accepted Answer

To monitor and improve drug safety

Answer

To manage drug prices

Answer

To ensure laboratory compliance

Answer

To oversee medical device quality

Question 3

Which organization is responsible for issuing GVP guidelines in the European Union?

Accepted Answer

EMA

Answer

FDA

Answer

WHO

Answer

ICH

Question 4

Which document outlines the obligations of a Marketing Authorization Holder (MAH) in pharmacovigilance?

Accepted Answer

Risk Management Plan

Answer

Safety Data Sheet

Answer

Clinical Trial Protocol

Answer

Certificate of Analysis

Question 5

How soon must a serious, unexpected adverse drug reaction be reported to regulatory authorities?

Accepted Answer

15 calendar days

Answer

7 calendar days

Answer

21 working days

Answer

30 calendar days

Question 6

What is the primary objective of the Periodic Safety Update Report (PSUR)?

Accepted Answer

To monitor benefit-risk profile

Answer

To assess clinical efficacy

Answer

To evaluate marketing strategy

Answer

To identify drug-drug interactions