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Pharmacovigilance Quiz

Question 1 of 12

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Question 1

What is Pharmacovigilance?

Drug marketing process

Monitoring drug safety

Clinical diagnosis

Drug manufacturing

Question 2

ADR stands for:

Adverse Drug Reaction

Advanced Drug Review

Additional Drug Report

Adverse Dose Record

Question 3

SAE stands for:

Safety Assessment Event

Serious Adverse Event

Standard Adverse Effect

Safety Analysis Error

Question 4

Who can report an adverse event?

Only doctors

Only pharma companies

Healthcare professionals and patients

Only regulators

Question 5

Which database is used globally for ADR reporting?

PubMed

VigiBase

Google Scholar

Medline

Question 6

What is causality assessment?

Checking drug price

Finding relation between drug and event

Manufacturing review

Clinical diagnosis

Question 7

What does MedDRA stand for?

Medical Dictionary for Regulatory Activities

Medical Drug Research Authority

Medicine Data Review Analysis

Medical Drug Registration Act

Question 8

PSUR stands for:

Product Safety Usage Report

Periodic Safety Update Report

Patient Safety Update Review

Pharmacology Study Update Record

Question 9

What is ICSR?

International Clinical Study Report

Individual Case Safety Report

Internal Case Study Review

Individual Clinical Safety Record

Question 10

Which phase detects rare adverse effects mostly?

Phase I

Phase II

Phase III

Phase IV

Question 11

What is signal detection?

Marketing strategy

Finding potential safety concerns

Drug manufacturing

Medical coding

Question 12

SUSAR means:

Suspected Unexpected Serious Adverse Reaction

Serious Unknown Safety Adverse Report

Safety Update Serious Adverse Reaction

Standard Unexpected Safety Assessment Report

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