PVC Regulatory Guidelines & Compliance 2 — Questions and Answers
Question 1: Under 21 CFR Part 314.81, what is the required timeframe for submitting a US IND Annual Report to the FDA?
- Within 30 days of the IND anniversary date (Correct answer)
- Within 60 days of the IND anniversary date
- Within 12 months of the IND anniversary date
- Within 90 days after year-end
Correct answer: Within 30 days of the IND anniversary date
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)?
- ICH E2A
- ICH E2B
- ICH E2F (Correct answer)
- ICH E2C(R2)
Correct answer: ICH E2F
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?
- 60 days after the data lock point
- 70 days after the data lock point
- 90 days after the data lock point (Correct answer)
- 30 days after the data lock point
Correct answer: 90 days after the data lock point
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?
- 7 calendar days
- 15 calendar days
- Included in periodic reports only (Correct answer)
- 30 calendar days
Correct answer: Included in periodic reports only
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?
- EU Clinical Trials Directive 2001/20/EC only
- EU Clinical Trials Regulation (EU) No 536/2014 (Correct answer)
- ICH E6(R2) GCP guideline
- EMA GVP Module I
Correct answer: EU Clinical Trials Regulation (EU) No 536/2014
EU Clinical Trials Regulation (EU) No 536/2014 governs pharmacovigilance and safety reporting for clinical trials conducted in the EU.
Question 6: Under FDA 21 CFR Part 600.80, what is the expedited reporting requirement for a serious, unexpected adverse experience associated with a biological product?
- 7 calendar days for fatal/life-threatening; 15 calendar days for other serious unexpected (Correct answer)
- 15 calendar days for all serious unexpected
- 30 days for all serious unexpected
- 7 calendar days for all serious unexpected
Correct answer: 7 calendar days for fatal/life-threatening; 15 calendar days for other serious unexpected
For biologics, fatal or life-threatening unexpected AEs require a 7-day alert report; other serious unexpected AEs require a 15-day expedited report.
Question 7: When the Responsible Person (RP) at an EU marketing authorization holder identifies a signal requiring urgent safety action, which GVP module guides the urgent safety restriction process?
- GVP Module V
- GVP Module IX
- GVP Module XVI (Correct answer)
- GVP Module VI
Correct answer: GVP Module XVI
GVP Module XVI specifically covers risk minimization measures, including urgent safety restrictions triggered by new safety signals.
PVC Regulatory Guidelines & Compliance 2
Under 21 CFR Part 314.81, what is the required timeframe for submitting a US IND Annual Report to the FDA?