Download RGUHS MSc Clinical Research 2019 October 4th Semester 9698 Pharmacovigilance Paper IV Question Paper

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[Time: 3 Hours]

[Max. Marks: 50]

PAPER IV: PHARMACOVIGILANCE

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Section B

Q.P. CODE : 9698

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Your answers should be specific to the questions asked.

Draw neat labeled diagrams wherever necessary. Answer all questions

(Note : Both QP Codes 9697 and 9698 are to be answered within total duration of 3 hours)

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(Use separate answer booklets for section A and section B)

LONG ESSAY

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1 X 20 = 20 Marks

1.

What is an ICSR? Discuss its sources, assessment and reporting requirements according to

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ICH. Add a note on Safety Signal.

SHORT ESSAY

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2 X 10 = 20 Marks

2.

Write a note on post marketing surveillance. Add a note on methods of surveillance.

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3.

Differentiate the following ?
AE-SAE

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AE-ADR
ICSR-PSUR
RMP-GMP
GCP-GLP

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SHORT NOTES

2 X 05 = 10 Marks

4.

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Write a note on the pharmacovigilance obligations of pharmaceutical companies.

5.

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Describe the important factors considered for causality assessment.

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