Pharmacovigilance Awareness Training, Module-I

10 Questions | Total Attempts: 694

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Pharmacovigilance Awareness Training, Module-I - Quiz


Questions and Answers
  • 1. 
    The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems is called Pharmacovigilance. This information is: 
    • A. 

      True

    • B. 

      False

  • 2. 
    Why Pharmacovigilance is needed for our products?
    • A. 

      Protection of patients

    • B. 

      Minimizing risks and taking appropriate measures

    • C. 

      Fulfil regulatory requirement of DGDA and/or PV Agreements with business partners

    • D. 

      All of the above

  • 3. 
    Any one can send an AE report to PV:
    • A. 

      Only in Office hour

    • B. 

      For 12 hours in a day

    • C. 

      For 24/7

    • D. 

      Open only for out of office coverage

  • 4. 
    You can send report to Department of Pharmacovigilance by:
    • A. 

      Phone call

    • B. 

      SMS

    • C. 

      E-mail

    • D. 

      All of the above

  • 5. 
    The basic criteria for a valid AE reports are:
    • A. 

      2

    • B. 

      3

    • C. 

      4

    • D. 

      5

  • 6. 
    Dedicated PV e-mail address of Department of Pharmacovigilance is:
  • 7. 
    A patient taking Radiant’s product ‘A’ informs you that she is experiencing arm pain. This is a known event already mentioned in the product label. Is this a reportable event?
    • A. 

      Yes, because this is an adverse event and must be reported even if the event is mentioned in the product label

    • B. 

      No, it is only necessary if the arm pain continues

    • C. 

      No, because the event is already mentioned in the product label so the patient should have expected it

  • 8. 
    At Radiant, what is the timeframe in which Adverse Event information must be reported to Department of Pharmacovigilance?
    • A. 

      Always report as soon as possible within 24 hours from when information first received

    • B. 

      Report within 24 hours in working days, however time may be extended in holidays and disruptive situation

  • 9. 
    Radiant & its Affiliates employees might learn about an “Adverse Event” from:  
    • A. 

      Patient

    • B. 

      Healthcare Professionals

    • C. 

      Literature article, social media

    • D. 

      All of the above

  • 10. 
    What should you do if you are not sure whether an information received by you is a reportable Adverse Event?
    • A. 

      Hold off reporting until you can receive more information

    • B. 

      Do not forward unless you are sure it is reportable

    • C. 

      Consult with PV Department in case of doubt

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