Pharmacovigilance Awareness Training, Module-I
- 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:
- A.
- B.
- C.
- D.
- 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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