PVC Regulatory Requirements & ICH Guidelines 2

Question 1

Under ICH E2A, what is the maximum timeframe for expedited reporting of a fatal or life-threatening unexpected SUSAR from a clinical trial?

Accepted Answer

7 calendar days

Answer

ICH E2A requires fatal or life-threatening unexpected SUSARs to be reported within 7 calendar days, with a follow-up report within 8 additional days.

Question 2

Which ICH guideline specifically addresses the format and content of individual case safety reports (ICSRs) submitted to regulatory authorities?

Accepted Answer

ICH E2B

Answer

ICH E2B defines the data elements and electronic transmission standards for ICSRs, including the E2B(R3) format based on HL7 ICSR.

Question 3

A company receives a serious adverse event report from a post-marketing study. Under FDA regulations, within what timeframe must they submit a 15-day Alert Report?

Accepted Answer

15 calendar days from initial receipt

Answer

FDA 21 CFR 314.81 requires 15-day Alert Reports for serious, unexpected post-marketing adverse drug reactions to be submitted within 15 calendar days of receipt.

Question 4

ICH E2E provides guidance on which pharmacovigilance planning activity?

Accepted Answer

Pharmacovigilance planning at the time of marketing authorization

Answer

ICH E2E guides development of pharmacovigilance plans as part of risk management at the time of marketing authorization application.

Question 5

Under EU GVP Module VI, which source of adverse event information does NOT typically qualify as a valid spontaneous report?

Accepted Answer

A report solicited through a patient support program

Answer

Solicited reports from organized data collection programs (e.g., patient support programs) are not considered spontaneous reports and should be handled as study reports.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Regulatory Requirements & ICH Guidelines 2