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

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Sc in Clinical Research (Master of Science in Clinical Research) 2019 October 4th Semester 9698 Pharmacovigilance Paper IV Previous Question Paper

Rajiv Gandhi University of Health Sciences

IV Semester M.Sc. [Clinical Research] Degree Examination ? OCT-2019

[Time: 3 Hours]

[Max. Marks: 50]

PAPER IV: PHARMACOVIGILANCE

Section B

Q.P. CODE : 9698

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)

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

LONG ESSAY

1 X 20 = 20 Marks

1.

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

ICH. Add a note on Safety Signal.

SHORT ESSAY

2 X 10 = 20 Marks

2.

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

3.

Differentiate the following ?
AE-SAE
AE-ADR
ICSR-PSUR
RMP-GMP
GCP-GLP

SHORT NOTES

2 X 05 = 10 Marks

4.

Write a note on the pharmacovigilance obligations of pharmaceutical companies.

5.

Describe the important factors considered for causality assessment.

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