Quiz 1 - Pharmacovigilance internship

What is Pharmacovigilance?
All of the above
Detection of adverse events
Understanding of adverse events
Prevention of adverse events
Select the correct answers:
There is a reasonable possibility that an adverse event has a causal relationship with the suspect product
The 4 minimum criteria for reporting an ICSR are: identifiable patient, adverse reaction, pharmaceutical form, suspect product
The adverse reaction is clearly related to the suspect drug
Adverse events reported from patient support programs are considered spontaneous sources
Which of the following reactions are included in type C (chronic)?
Fracture - bisphosphonates
Sore arm - vaccine
Anaphylactic reaction - Antibiotics
Gastritis - NSAID
PSMF and QPPV should be located in EU/EEA.
True
False
It is not necessary to update the RMP.
True
False
0
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