Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Pharm SEMESTER-VII • EXAMINATION WINTER-2016
Subject Code: 2270010 Date: 29/11/2016
Subject Name: Pharmacovigilance
Time: 10.30 am 01.30 pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Define Pharmacovigilance. Write in brief about the methods of Pharmacovigilance
06

Write a short note on impact of ADRs on public health
05

Discuss pharmacogenetic causes of ADRs
05
Q.2

Define ADRs. What are the types of ADRs
06

Write a note on adverse drug reactions of liver.
05

Explain ICSR. Discuss its role in Pharmacovigilance
05
Q.3

Write a note on Pharmacovigilance in clinical trials
06

What are the merits and demerits of spontaneous ICSR reporting systems
05

Write a brief note on SSFFC medicines
05
Q.4

Discuss the causes and prevention of medication errors.
06

Explain the terms Medication errors medDRA
05

Discuss the format of spontaneous reporting system.
05
Q.5

Discuss sources and scope of signal detection.
06

Give brief account on WHO international drug monitoring programme
05

Discuss the various mechanisms of ADRs
05
Q. 6

Discuss the contents and structure of Individual Case Safety Reports
06

Write in short about the cutaneous adverse drug reactions
05

Give explanation to Pattern and scale of counterfeiting
05
Q.7

Discuss about Pharmacovigilance system in INDIA
06

Write a brief note on ADRs of various anti infective drugs
05

Discuss the validity and assessment of ICSRs reports
05