Pharmacovigilance At Cipla Training Assessment 2016

5 Questions | Total Attempts: 275

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Pharmacovigilance At Cipla Training Assessment 2016

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Questions and Answers
  • 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:‚Äč
  • 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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