AI in Drug Safety and Pharmacovigilance Quiz

Answers and explanations appear as you take the quiz.

1. What is the primary goal of pharmacovigilance?
   • Detecting, assessing, and preventing harm from medicines after they are used
   • Marketing new drugs to physicians
   • Setting the retail price of medications
   • Designing pill packaging
2. In the published n2c2 clinical NLP system, what information did the system extract from narrative notes?
   • Only patients’ handwritten signatures
   • Medication and adverse-event concepts and their relations
   • Only final regulatory decisions
   • Only medicine prices
3. What does disproportionality analysis detect in adverse-event databases?
   • The price difference between brand and generic drugs
   • Which hospital submitted the most reports
   • Drug-event pairs reported more often than statistical chance would predict
   • The expiry dates of medications
4. What is VigiBase, according to Uppsala Monitoring Centre?
   • A database of randomized clinical-trial efficacy results only
   • A list of confirmed causal side effects for every medicine
   • A commercial catalogue of approved drug prices
   • The WHO global database of reported adverse events for medicines and vaccines
5. What is MedDRA used for in pharmacovigilance pipelines?
   • A standardized medical vocabulary for coding reactions and conditions
   • A brand of pharmaceutical packaging
   • A scheduling app for doctors
   • A type of MRI scanner
6. Which sequence does UMC describe in its signal-management process?
   • Diagnosis, prescription, dispensing, billing and discharge
   • Detection, validation, prioritisation, assessment and communication
   • Data collection, automatic causality decision, recall and litigation
   • Model training, deployment, billing and marketing
7. How should a high disproportionality score in a spontaneous-report database be interpreted?
   • As a population incidence rate for all patients
   • As a confirmed causal adverse reaction
   • As a statistical signal for further assessment, not proof that the drug caused the event
   • As proof that no other factor contributed
8. Which four elements satisfy the minimum ICSR criteria in ICH E2D(R1)?
   • A confirmed causal link, a batch number, a prescriber signature, and a laboratory result
   • A product label, a randomized trial, a treatment response, and a safety committee vote
   • A hospital admission, a known dose, a genetic profile, and a published case report
   • An adverse event or other observation, a suspect or interacting product, an identifiable patient, and an identifiable reporter