What is NOT correct about the content of the PSUR

Only confirmed signals should be described

The abbreviation PSMF stands for?

Pharmacovigilance System Master File

What are the 4 minimum criterias for a valid Adverse Drug Reaction?

Suspected product, Identifiable reporter, Adverse event, Patient info

Which of the following is NOT considered as a serious criterium for an Adverse Reaction?

The adverse reaction has economic consequences for the patient

What is the definition of an Adverse Drug Reaction?

A response to a medicinal product which is noxious and unintended

What is the definition of a SUSAR

Suspected Unexpected Serious Adverse Reaction

How are patients informed about the risk associated with taking a product?

They can find the information in the Patient Information Leaflet

The QPPV is responsible for…?

Establish and maintain the MAHs PV system

In clinical trials: Is an abnormal blood test result to be considered as an adverse event?

Yes, if the test is taken after signing off the inform consent

According to the Clinical Trial Directive which Adverse Events require single case reporting to the Regulatory Authority

All SUSARs (Suspected Unexpected Serious Adverse Reactions)

What is the meaning of a Listed/Expected adverse reaction?

The adverse reaction is mentioned in the safety reference document

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Intro to Drug Safety & Pharmacovigilance

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Questions 22

Answers

1
What is NOT correct about the content of the PSUR
Evaluation of product Risk/Benefit should be included
Table with Adverse Reaction should be split in different population
SAEs from clinical trials are included in a line listing
Only confirmed signals should be described
2
The abbreviation PSMF stands for?
Pharmacovigilance System Master File
Personal Summary of Manufacturing Files
Personal System Master File
Pharmacovigilance Summary of Manufacturing Files
3
According to Peter; Coding with MedDRA is....
Difficult
Insignificant
Fun
Boring
4
Which of the following cannot be coded in MedDRA
Social and family history
Descriptors of severity
Signs & symptoms
Surgical and medical procedures
5
How many LLT terms exist in the MedDRA coding dictionary?
89774 terms
8181 terms
Between 1000-2000 terms
27 terms
6
What are the 4 minimum criterias for a valid Adverse Drug Reaction?
Suspect product, Medical confirmation, Identifiable reporter, Adverse event
Patient info, Suspect product, Identifiable reporter, Medical confirmation
Suspected product, Identifiable reporter, Adverse event, Patient info
Medical confirmation, Identifiable reporter, Adverse event, Suspect product
7
Which of the following is NOT a Health Care Professional?
Physician
Nurse
Lawyer
Pharmacist
8
In clinical development how many ideas reaches the market?
1:10000
1:100000
1:100
1:1000
9
Which of the following is NOT considered as a serious criterium for an Adverse Reaction?
The adverse reaction caused hospitalization
The adverse reaction caused disability
The adverse reaction has economic consequences for the patient
The reaction required intervention to avoid a life threatening situation
10
What is the definition of an Adverse Drug Reaction?
A response to a medicinal product which is noxious and unintended
A response to a medicinal product which is unintended
A response to a medicinal product that has not previously been observed
A response to a medicinal product which is noxious and intended
11
What is the definition of a SUSAR
Serious Unexpected Suspected Adverse Reaction
Serious Unrelated Suspected Adverse Reaction
Suspected Unexpected Serious Adverse Reaction
Suspected Unrelated Serious Adverse Reaction
12
In clinical trials: What is the investigators timeline for reporting of Serious Adverse Event to the sponsor?
When he has time to fill in the SAE form
2 business days
24 hours
2 calendar days
13
How are patients informed about the risk associated with taking a product?
They only know if they experience something abnormal themselves
They will have to look on the internet
They can find the information in the Patient Information Leaflet
They only know if the physician tells them
14
The QPPV is responsible for…?
Establish and maintain the MAHs PV system
Create an ambitious pipeline for the survival of the company
Ensuring good cooking in the canteens to keep employees healthy
The QPPV is the ‘Quiz ProPerson virtual’ in a company
15
In clinical trials: Is an abnormal blood test result to be considered as an adverse event?
No
Yes, if the test is taken after signing off the inform consent
Only if the test is taken after product administration
I don't know
16
What should you preferable be when conducting non-interventional studies
An elephant in a porcelain shop
Sly as a fox
A fly on the wall
Bambi on the ice
17
According to the Clinical Trial Directive which Adverse Events require single case reporting to the Regulatory Authority
All SAR (Serious Adverse Reactions)
All SUSARs (Suspected Unexpected Serious Adverse Reactions)
All ARs (Adverse Reactions)
All SAEs (Serious Adverse Events)
18
What is the meaning of a Listed/Expected adverse reaction?
The adverse reaction is mentioned in the safety reference document
The consumer suspect that the adverse reaction is caused by the product
The adverse reaction is considered caused by the product by a physician
The MAH suspect that the adverse reaction is caused by the product
19
What is NOT an abbreviation of a Reference Safety Document in a product lifecycle?
DCSI
NCIS
SmPC
CCSI
20
How many patients are estimated to suffer from Adverse Reactions during a hospitalisation
2%
5%
20%
10%
21
What is the reporting timeline for non-serious Adverse Drug Reactions in EU ?
30 days
90 days
2 weeks
15 days
22
In which section of the Reference Safety Document will you look for the Adverse Reactions?
In section 4.8
In all sections of the Reference document
The Document does not contain information about Adverse reactions
In the section containing information about result from clinical studies

Intro to Drug Safety & Pharmacovigilance Flashcards | StudBud