B.PharmSemester 82021-22PharmacovigilanceBP805ET

Pharmacovigilance (BP805ET) - AKTU Question Paper 2021-22

B.Pharm · Semester 8 · Free PDF Download

This is the official AKTU Pharmacovigilance Previous Year Question Paper for B.Pharm Semester 8, academic session 2021-22. 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:2021-22

University:AKTU / UPTU

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Questions Asked in 2021-22

Pharmacovigilance (BP805ET) — complete question paper

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 drug event monitoring?
b
List four drugs contraindicated in pregnant and lactating women
c
Suggest the requirements for CIOMS form
d
What is eudravigilance?
e
What is teratogenicity? Give examples
f
What is post marketing safety?
g
Narrate the minimum criteria required for a valid report?
h
What is phase IV of clinical trials? i. What are the basic objectives of pharmacovigilance planning? j. Mention few examples of predictable adverse drug reactions

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
Classify adverse drug reac tion. How will you detect and report ADR along with causality assessment scales?
b
Discuss in detail basic and specialized drug information resour ces in
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
Explain the establishing pharmacovigilance program in the hospital
b
What is vaccine safety surveillan ce? Explain in detail differen t types of pharmacovigilance methods used for passive and active surveillance
c
Discuss in detail establishment and operation of drug safety de partment in pharmaceutical industry
d
Mention the importance aspects of ICH guidelines for expedited reporting
e
Write short note on pharmacoge nomics on adverse drug reaction
f
How will you carry out drug safety evaluation in geriatric and pediatric populations?
g
What is the role of CDSCO in pharmacovigilance? Write a note on ATC classification of drugs

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 drug event monitoring?