what is another word for Pharmacovigilance
All adverse events received must be reported within what timeframe?
24hours
What is the full meaning of FDA?
Food and Drug Administration
What does ICSR Stand for ?
Individual Case Safety Report.
What are the four things needed to have a reportable event?
A patient, a reporter, a product, and an event
Who is the LPVRP for the US Region?
Liang Huang (Leon)
What is the full meaning of WHO
World Health Organization
Adverse Event of Special Interest
Who is the Deputy LPVRP for the US region?
Sunanda Sharma
What is the full meaning of LPVRP
Local Pharmacovigilance Responsible Person
What does SAE Stand for ?
Serious Adverse Event.
These must be submitted to regulatory authority within 7-15 days
How many pharmacovigilance personnel are there in the US office?
Five
Which of the following special situation scenarios should be reported?
Drug Abuse, Misuse, Overdose
Off-label use
Lack of therapeutic efficacy
Patient becoming pregnant while on Glenmark Medicine
Occupational Exposure
Medication errors
All of Above
is experiencing diarrhea after using a product is a reportable event?
Yes
What is the name of the new Global PV Head?
Rajendra Kasi