PVC Regulatory Guidelines & Compliance 1

Question 1

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

Accepted Answer

ICH E2A

Answer

ICH E2A guideline outlines the clinical safety data management of individual case safety reports (ICSRs).

Question 2

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

Accepted Answer

To monitor and improve drug safety

Answer

GVP guidelines ensure the safety of medicinal products by defining responsibilities for pharmacovigilance systems within regulatory frameworks.

Question 3

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

Accepted Answer

EMA

Answer

The European Medicines Agency (EMA) is the authority that develops and maintains GVP modules in the EU.

Question 4

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

Accepted Answer

Risk Management Plan

Answer

The Risk Management Plan (RMP) specifies the pharmacovigilance obligations for MAHs to minimize product risks.

Question 5

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

Accepted Answer

15 calendar days

Answer

According to ICH E2A and GVP, serious and unexpected ADRs must be reported within 15 calendar days.

(PVC) Pharmacovigilance Certification Practice Test