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) — extracted question text
Section AAttempt all q u e s t i o n s i n b r i e f . 10 x 2 = 20
- aWhat is drug event monitoring?
- bList four drugs contraindicated in pregnant and lactating women
- cSuggest the requirements for CIOMS form
- dWhat is eudravigilance?
- eWhat is teratogenicity? Give examples
- fWhat is post marketing safety?
- gNarrate the minimum criteria required for a valid report?
- hWhat 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
- aClassify adverse drug reac tion. How will you detect and report ADR along with causality assessment scales?
- bDiscuss in detail basic and specialized drug information resour ces in
- cDiscuss 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
- aExplain the establishing pharmacovigilance program in the hospital
- bWhat is vaccine safety surveillan ce? Explain in detail differen t types of pharmacovigilance methods used for passive and active surveillance
- cDiscuss in detail establishment and operation of drug safety de partment in pharmaceutical industry
- dMention the importance aspects of ICH guidelines for expedited reporting
- eWrite short note on pharmacoge nomics on adverse drug reaction
- fHow will you carry out drug safety evaluation in geriatric and pediatric populations?
- gWhat 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. Check the original PDF for equations, diagrams and complete wording. Extracted: 2026-08-23.
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