Pharmacovigilance At Cipla Training Assessment 2016
.
- 1.The science related to detection, monitoring and prevention of______________ is termed as Pharmacovigilance.
- A.
All Complaints received on medicines
- B.
Adverse events
- C.
Diseases
- D.
Product Quality Complaints
- 2.A patient informs you about having an allergy when she started a Cipla drug, within what time frame should you forward a report the Cipla SA, Drug Safety Unit?
- A.
Within 1 business day, or 3 calendar days (whichever is earlier) of when you read the information
- B.
Within 1 business day, or 3 calendar days (whichever is earlier) from when the information is first received
- C.
Within 48 hours of your awareness
- D.
No safety report is required because the AE is mentioned in the Product label
- 3.All Adverse Events on Cipla products should be emailed to:
- A.
- B.
- C.
- D.
- 4.Pharmacovigilance activities, if not conducted in line with regulatory requirements can lead to product withdrawal.
- A.
True
- B.
False
- 5.Your friend mentions to you that her doctor has prescribed Ginette for treatment of hair loss, even though you are aware that this is not an approved indication/use of the drug. According to your friend's HCP, several patients have seen great results and she is optimistic about the treatment. Do you have to report this?
- A.
No, you do not need to forward a report since the Health Care Professional has written a script for the patient.
- B.
No, it is not required to forward a report as it is not part of your obligation.
- C.
Yes, Forward a product safety report of this off-label use.
- D.
No safety report is required because there were no unexpected adverse events.
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