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BPHARM
(SEM VIII) THEORY EXAMINATION 2023-24
PHARMACOVIGILANCE
TIME: 3 HRS M.MARKS: 75
Note: Attempt all Sections. If require any missing data; then choose suitably.
SECTION A
1. Attempt all questions in brief. 10 x 2 = 20
a. What is adverse drug reaction?
b. Mention the differences between drug toxicity and drug abuse.
c. What is eudravigilance?
d. What is drug event monitoring?
e. List four drugs contraindicated in padiatric patients.
f. What is post marketing safety?
g. Narrate the minimum criteria required for a valid report.
h. Mention the salient features of Phase III of clinical trial.
i. What do you mean by teratogenicity?
90
1
j. What is ATC classification of drugs?
13
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2.
SECTION B
P1
24
2. Attempt any two parts of the following: 2 x 10 = 20
4D
a. Discuss the importance of safety monitoring of medicine. Highlight the salient
5.
features of the Pharmacovigilance Program of India (PvPI)
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P2
17
b. How will you set up the establishment & operation of drug safety department in
Q
industry? Mention its rationale of such set up.
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c. Discuss in detail of Cohort and case control study. Explain the applications of
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MedDRA and standard MedDra queries.
4
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SECTION C
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3. Attempt any five parts of the following: 7 x 5 = 35
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a. Suggest some examples of vaccination failure. How will you control such failures
4
in future?
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b. Mention the importance aspects of ICH guidelines for expedited reporting
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c. What is the role of CDSCO in pharmacovigilance? Write a note on ATC
01
classification of drugs
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d. How will you carry out drug safety evaluation in pregnant woman and geriatric
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patients?
e. Write short notes on CIOMS
f. Suggest the role of genetics related ADR with examples
g. Write short note on pharmacogenomics on adverse drug reaction
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QP24DP1_290 | 24-01-2024 13:41:49 | 117.55.242.131
Printed Pages: 01 Sub Code: BP-805ET
Paper Id: 231140 Roll No.
B PHARM
(SEM VIII) THEORY EXAMINATION 2022-23
PHARMACOVIGILANCE
Time: 3 Hours Total Marks: 75
Note: Attempt all Sections. If require any missing data; then choose suitably.
SECTION A
1. Attempt all questions in brief. 2 x 10 = 20
(a) Define the adverse drug reaction.
(b) Compute the limitations of detecting ADRs in clinical trials.
(c) Discuss the PSUR.
(d) Classify ADRs according to severity.
(e) List out factors affecting adverse effects of the vaccine.
(f) What is phase IV of clinical trials?
(g) What are CIOMS working groups?
(h) Discuss the cohort study with example.
2
(i) Discuss the Defined daily doses.
90
13
(j) Illustrate the importance of Pharmacogenomics.
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2.
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SECTION B
5.
3D
2. Attempt any two parts of the following: .5 10 x 2 = 20
P2
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(a) Differentiate between adverse drug reactions and adverse events with suitable examples.
Q
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Explain the mechanisms of Type-A and Type-B ADRs.
2
(b) Illustrate the vaccine safety surveillance along with the different types of
5
pharmacovigilance methods used for passive and active surveillance.
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(c) Explain the drug safety evaluation in pediatrics and geriatrics.
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13
SECTION C
3
02
3. Attempt any five parts of the following: 7 x 5 = 35
-2
(a) Characterize the different methods of causality and severity assessment of ADRs and
01
explain Naranjo’s scale.
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(b) Demonstrate the prerequisite for setting up a pharmacovigilance center in a CRO and
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hospital.
(c) Define vaccine. Explain reasons for vaccination failure.
(d) Summarize the ATC classification of drugs with example.
(e) Explore the Pre- marketing and Post-marketing clinical trials.
(f) Illustrate the organization and objectives of ICH.
(g) Explain the Schedule Y of Drugs and Cosmetics Act in brief.
QP23DP1_290 | 07-01-2023 13:31:52 | 117.55.242.132