B.PharmSemester 82023-24PharmacovigilanceBP805ET

Pharmacovigilance (BP805ET) - AKTU Question Paper 2023-24

B.Pharm · Semester 8 · Free PDF Download

This is the official AKTU Pharmacovigilance Previous Year Question Paper for B.Pharm Semester 8, academic session 2023-24. Published by Dr. A.P.J. Abdul Kalam Technical University (AKTU/UPTU), Lucknow. Free PDF download — no login required.

Course:B.Pharm

Semester:Semester 8

Session:2023-24

University:AKTU / UPTU

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Questions Asked in 2023-24

Pharmacovigilance (BP805ET) — complete question paper · 75 marks · 3 Hours

Section AAttempt all q u e s t i o n s i n b r i e f . 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 t eratogenicity? j. What is ATC classification of drugs?

Section BAttempt any two p a r t s o f t h e f o l l o w i n g : 2 x 10 = 20

a
Discuss the importance of s afety monitoring of medicine. Highlight the salient features of the Pharmacovigilance Program of India (PvPI)
b
How will you set up the establishment & operation of drug sa fety department in industry? Mention its rationale of such set up
c
Discuss in detail of Cohort and case control study. Explain the applications of MedDRA and standard MedDra queries

Section CAttempt any five p a r t s o f t h e f o l l o w i n g : 7 x 5 = 35

a
Suggest some examples of v accination failure. How will you control such failures in future?
b
Mention the importance aspects of ICH guidelines for expedited reporting
c
What is the role of CDSCO in pharmacovigilance? Write a note on ATC classification of drugs
d
How will you carry out drug safety evaluation in pregnant woman and geriatric patients?
e
Write short notes on CIOMS
f
Suggest the role of genetic s related ADR with examples
g
Write short note on pharmacogenomics on adverse drug reaction

Question text is extracted from the official AKTU question paper PDF above. Hindi translations are omitted — every question is printed in English in the original paper. Last verified: 2026-08-23.

Repeated Questions — BP805ET

Questions that appeared in more than one session, found by comparing 3 years of Pharmacovigilance papers (2021-22, 2022-23, 2023-24)

What is adverse drug reaction?

Appeared in: 2022-23 · 2023-24

What is eudravigilance?