CTA Pharmacovigilance & Drug Safety Flashcards
6 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CTA Pharmacovigilance & Drug Safety flashcards as text
What is the purpose of a Risk Management Plan (RMP) in pharmacovigilance?
Answer: To describe safety concerns of a medicine and how identified risks will be characterized, minimized, and communicated
An RMP is a regulatory document that describes a medicine's known and potential safety concerns and outlines the measures planned to minimize and monitor those risks.
What is a Periodic Benefit-Risk Evaluation Report (PBRER)?
Answer: A periodic regulatory submission that evaluates the benefit-risk profile of an authorized medicinal product
A PBRER is a periodic pharmacovigilance report submitted to regulatory authorities that evaluates the benefit-risk balance of an approved product based on all accumulated safety data.
What is the Medical Dictionary for Regulatory Activities (MedDRA)?
Answer: A standardized international medical terminology used to code adverse events and medical conditions in clinical trials
MedDRA is a globally harmonized, standardized medical terminology used by regulatory authorities and the pharmaceutical industry to code clinical data, including adverse events, in a consistent manner.
In signal detection for pharmacovigilance, what is a 'signal'?
Answer: Information from one or more sources suggesting a new or changed association between a medicine and an adverse event
A pharmacovigilance signal is information suggesting a new or changed association between a medicine and an adverse event that warrants further investigation, but does not necessarily confirm causality.
What is the primary function of a global safety database in pharmacovigilance?
Answer: To collect, manage, and report all individual case safety reports (ICSRs) for a product
A global safety database centralizes all individual case safety reports received for a product, enabling aggregate analysis, signal detection, and regulatory reporting.
What is a Dear Healthcare Provider (DHCP) letter used for in drug safety?
Answer: To communicate important new safety information about a marketed product to prescribers
A DHCP letter (also called a Dear Doctor letter) is a risk communication tool used to rapidly disseminate important safety information about a marketed drug to prescribers and other healthcare professionals.