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) — extracted question text · 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. Check the original PDF for equations, diagrams and complete wording. Extracted: 2026-08-23.

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