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    Unit I & II Question Bank

    Uploaded by

    Mohamed Muhsin
    1) The document outlines questions for a pharmacovigilance exam covering topics like the yellow card scheme, definitions of key terms like pharmacovigilance and adverse drug reactions, the missions of organizations like UMC, and the structure and functions of organizations like PvPI. 2) It also includes questions about drug classification systems like ATC and coding systems like MedDRA, resources used in pharmacovigilance like drug dictionaries, and the roles of pharmacists and industry in monitoring and reporting adverse drug reactions. 3) The document provides short answer questions worth 2-5 marks and longer answer questions worth 10 marks on topics relating to the monitoring, detection, reporting and

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    © All Rights Reserved
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    Unit I & II Question Bank

    Uploaded by

    Mohamed Muhsin
    324 views3 pages
    1) The document outlines questions for a pharmacovigilance exam covering topics like the yellow card scheme, definitions of key terms like pharmacovigilance and adverse drug reactions, the missions of organizations like UMC, and the structure and functions of organizations like PvPI. 2) It also includes questions about drug classification systems like ATC and coding systems like MedDRA, resources used in pharmacovigilance like drug dictionaries, and the roles of pharmacists and industry in monitoring and reporting adverse drug reactions. 3) The document provides short answer questions worth 2-5 marks and longer answer questions worth 10 marks on topics relating to the monitoring, detection, reporting and

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    Pharmacovigilance question

    Original Title

    Unit I & II question bank

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    1) The document outlines questions for a pharmacovigilance exam covering topics like the yellow card scheme, definitions of key terms like pharmacovigilance and adverse drug reactions, the missions of organizations like UMC, and the structure and functions of organizations like PvPI. 2) It also includes questions about drug classification systems like ATC and coding systems like MedDRA, resources used in pharmacovigilance like drug dictionaries, and the roles of pharmacists and industry in monitoring and reporting adverse drug reactions. 3) The document provides short answer questions worth 2-5 marks and longer answer questions worth 10 marks on topics relating to the monitoring, detection, reporting and

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    324 views3 pages

    Unit I & II Question Bank

    Uploaded by

    Mohamed Muhsin
    1) The document outlines questions for a pharmacovigilance exam covering topics like the yellow card scheme, definitions of key terms like pharmacovigilance and adverse drug reactions, the missions of organizations like UMC, and the structure and functions of organizations like PvPI. 2) It also includes questions about drug classification systems like ATC and coding systems like MedDRA, resources used in pharmacovigilance like drug dictionaries, and the roles of pharmacists and industry in monitoring and reporting adverse drug reactions. 3) The document provides short answer questions worth 2-5 marks and longer answer questions worth 10 marks on topics relating to the monitoring, detection, reporting and

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    BP805T: Pharmacovigilance

    Unit I:

    2Marks questions:

    1) What is mean of yellow card scheme?


    2) Define the following:
    a. Pharmacovigilance
    b. ADR and AE
    c. Causality assessment
    d. De-challenge
    e. ICSR
    f. Omega
    g. PSUR
    h. Predisposing factors
    i. Reference and Relative risk
    j. Signal
    k. MedDRA
    3) Mention different classes of ADR.
    4) Enumerate the missions of UMC.
    5) What is PvPI? Give its operating centers
    6) Name any two software and database used in pharmacovigilance program.
    7) Give the application of Hartwig’s scale.
    8) Enlist the mandatory information for ADR reporting.
    9) Define Adverse event.

    5 Marks questions

    1) Briefly discuss the missions of UMC


    2) Write about need of pharmacovigilance in present scenario.
    3) Discuss the objectives and goals of PvPI
    4) Outline the organization structure and communication system of PvPI
    5) Discuss the severity and seriousness assessment of ADR
    6) Discuss the predictability and preventability of ADR
    7) Write a note on Hartwig’’s scale and its application.

    8) Role of Pharmacist in management of ADRs


    9) Discuss the predisposing factors influencing ADR.

    10 Marks questions

    1) Explain in detail the structure and function of PvPI.


    2) Elaborate the methods in causality assessment for ADR
    3) Give detailed account on monitoring and reporting system on ADR
    4) Explain the methods for detection and reporting of ADR.

    Unit-II

    2 Marks questions

    1) What are the general principles of ATC classification


    2) Mention the purpose of ATC classification.
    3) Describe ICD. Give its importance.
    4) Define DDD and give any two applications of it.
    5) Expand the term ‘INN’ and Give its uses.
    6) State the types of resources with example for each.
    7) Name various drug dictionaries used in pharmacovigilance.
    8) Enlist any four specialized resources for ADR.
    9)

    5 Marks Questions

    1) Write a note on ATC classification and coding on drugs.


    2) Briefly discuss the international classification of disease
    3) Give account on basic drug information resources and its types.
    4) Write a note on specialized resources of ADR.
    5) Write a note on MedDRA and coding.
    6) Write a note the scope and development of MedDRA.
    7) Outline the features of Eudravigilance-medical product dictionary.
    8) Explain the minimum information to be furnished in case reporting form.

    10 Marks Questions

    1) Explain the drug dictionaries and coding in pharmacovigilance.


    2) Write in detail about various resources in pharmacovigilance
    3) Elaborate the establishment of pharmacovigilance program in hospital.
    4) Explain the construction and function of drug safety department in pharmaceutical
    industry.

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