PVC Regulatory Guidelines & Compliance 2

Question 1

Under 21 CFR Part 314.81, what is the required timeframe for submitting a US IND Annual Report to the FDA?

Accepted Answer

Within 30 days of the IND anniversary date

Answer

The IND Annual Report must be submitted within 60 days of the anniversary of the IND effective date per 21 CFR 312.33.

Question 2

Which ICH guideline specifically addresses the content and format of the Development Safety Update Report (DSUR)?

Accepted Answer

ICH E2F

Answer

ICH E2F provides guidance on the development, format, and content of the Development Safety Update Report (DSUR).

Question 3

A marketed drug's PSUR/PBRER covers a data lock point. According to ICH E2C(R2), what is the maximum submission timeline for a PBRER covering a 12-month period?

Accepted Answer

90 days after the data lock point

Answer

ICH E2C(R2) requires that a PBRER for a 12-month period be submitted within 90 days of the data lock point.

Question 4

EMA's Good Pharmacovigilance Practices (GVP) Module VI specifies which of the following as a non-serious adverse reaction reporting timeframe for marketed products?

Accepted Answer

Included in periodic reports only

Answer

Under GVP Module VI, non-serious ADRs for marketed products are not individually expedited but are included in periodic safety reports.

Question 5

Which regulatory framework governs pharmacovigilance obligations for sponsors conducting clinical trials within the European Union?

Accepted Answer

EU Clinical Trials Regulation (EU) No 536/2014

Answer

EU Clinical Trials Regulation (EU) No 536/2014 governs pharmacovigilance and safety reporting for clinical trials conducted in the EU.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Regulatory Guidelines & Compliance 2