PVC Periodic Safety Update Reports 2

Question 1

What is the International Birth Date (IBD) of a medicinal product used in PSUR scheduling?

Accepted Answer

The date the product received its first marketing authorization anywhere in the world

Answer

The IBD is the date of first marketing authorization for a medicinal product anywhere in the world, which anchors the PSUR submission schedule.

Question 2

In ICH E2C(R2), what does the 'data lock point' (DLP) refer to in a PSUR?

Accepted Answer

The date after which no new safety data is included in the current PSUR

Answer

The data lock point is the cut-off date for including safety data in a PSUR; data received after this date is excluded from the current report.

Question 3

Which section of the PSUR specifically addresses the benefit-risk evaluation of the product?

Accepted Answer

Integrated Benefit-Risk Analysis for Approved Indications

Answer

ICH E2C(R2) designates a dedicated Integrated Benefit-Risk Analysis section where the MAH evaluates the overall benefit-risk balance for approved indications.

Question 4

Under the EU pharmacovigilance legislation (Regulation 726/2004), what is the standard PSUR submission frequency for a product in the first two years post-authorization?

Accepted Answer

Every 6 months

Answer

EU legislation requires PSURs every 6 months for the first 2 years following initial marketing authorization.

Question 5

What is a PSUR Single Assessment (PSUSA) in the European context?

Accepted Answer

A single EU-coordinated assessment of PSURs for products containing the same active substance

Answer

PSUSA is a procedure where EMA coordinates a single harmonized assessment of PSURs for all EU-authorized products sharing the same active substance.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Periodic Safety Update Reports 2