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[Max. Marks: 100]
REGULATORY AFFAIRS PHARMACOVIGILANCE AND
PHARMACOECONOMICS ? PAPER I
Q.P. CODE: 9684
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY
2 X 20 = 40 Marks
1.
How does anyone report an adverse drug reaction?
2.
are the timelines and responsibilities of sponsor in reporting SAE in any clinical trial
SHORT ESSAY
3.
What is a Standard Operating Procedure (SOP)? What is the importance of an SOP? Write in
4.
Responsibilities of sponsor in a clinical trial
5.
Audit in Clinical Trial Brief the difference between Inspection and Audit
How is causality assessment done in a suspected adverse drug reaction. Mention some scales
and tools used for causality assessment with examples.
What is direct cost and indirect costs? Describe this in the context of a pharmacoeconomic
study.
2 X 5 =10 Marks
8.
Periodic Safety Update of reports (PSUR)
9.
* * * * *
[Max. Marks: 100]
REGULATORY AFFAIRS PHARMACOVIGILANCE AND
--- Content provided by FirstRanker.com ---
PHARMACOECONOMICS ? PAPER I
Q.P. CODE: 9684
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Your answers should be specific to the questions asked.Draw neat, labeled diagrams wherever necessary.
LONG ESSAY
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2 X 20 = 40 Marks
1.
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How do we monitor adverse drug reaction in India? What is the name of the national program.How does anyone report an adverse drug reaction?
2.
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What is definition of a Serious Adverse Event as per Schedule Y of the Indian D&C Act. Whatare the timelines and responsibilities of sponsor in reporting SAE in any clinical trial
SHORT ESSAY
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5 X 10 = 50 Marks3.
What is a Standard Operating Procedure (SOP)? What is the importance of an SOP? Write in
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short, a SOP for measuring blood pressure.4.
Responsibilities of sponsor in a clinical trial
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5.
Audit in Clinical Trial Brief the difference between Inspection and Audit
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6.How is causality assessment done in a suspected adverse drug reaction. Mention some scales
and tools used for causality assessment with examples.
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7.What is direct cost and indirect costs? Describe this in the context of a pharmacoeconomic
study.
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SHORT NOTES2 X 5 =10 Marks
8.
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Periodic Safety Update of reports (PSUR)
9.
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CTRI and its importance* * * * *