Regulatory Guidelines & Compliance Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Guidelines & Compliance flashcards as text
Which EU regulation established the legal basis for mandatory pharmacovigilance requirements for centrally authorized medicinal products?
Answer: Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010
Regulation (EC) No 726/2004 amended by Regulation (EU) No 1235/2010 established mandatory pharmacovigilance requirements including QPPV and PSMF for centrally authorized products.
In the context of US post-marketing surveillance, what is a 'Periodic Adverse Drug Experience Report' (PADER) and when is it submitted?
Answer: A quarterly then annual report summarizing all US post-marketing AE data required under 21 CFR 314.81
Under 21 CFR 314.81, PADERs are submitted quarterly for the first 3 years after approval, then annually, summarizing all post-marketing adverse drug experiences.
What is the legal obligation of an EU Marketing Authorization Holder (MAH) regarding a Pharmacovigilance System Master File (PSMF)?
Answer: Maintain it at the QPPV's principal place of business and make it available to competent authorities within 7 days upon request
The PSMF must be maintained at the QPPV's principal place of business and provided to competent authorities within 7 days upon request.
Under 21 CFR 312.32, which of the following obligates an IND sponsor to submit a 15-day expedited report?
Answer: A serious and unexpected adverse drug reaction from a foreign clinical study
21 CFR 312.32 requires IND sponsors to submit 15-day expedited reports for serious and unexpected adverse drug reactions regardless of whether they occur in US or foreign studies.
GVP Module IX defines signal management. Which of the following best describes a 'validated signal' in pharmacovigilance?
Answer: A signal for which the data are sufficient to justify further action such as a detailed evaluation
A validated signal is one where the available information justifies further evaluation; it does not yet confirm causality but warrants more detailed analysis.
Which FDA guidance document describes the content and format requirements for the Investigational New Drug Safety Reporting regulations finalized in 2011?
Answer: FDA Guidance: Safety Reporting Requirements for INDs and BA/BE Studies (2012)
The FDA's 2012 guidance 'Safety Reporting Requirements for INDs and BA/BE Studies' describes implementation of the 2011 final rule for IND safety reporting.
When assessing an adverse event for 'expectedness' in the post-marketing setting for an EU product, what document serves as the Reference Safety Information?
Answer: The Company Core Data Sheet (CCDS) or the locally approved Summary of Product Characteristics (SmPC)
For post-marketing products in the EU, expectedness is assessed against the Company Core Data Sheet (CCDS) or the locally approved SmPC, whichever is applicable.