JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B.Pharmacy IV Year PHARMACOVIGILANCE Previous Question Paper (June/July - 2024 - R17)
Note: i) Question paper consists of Part A, Part B. ii) Part A is compulsory, which carries 25 marks. In Part A, Answer all questions. iii) In Part B, Answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
Define unexpected Adverse drug reaction.
Answer
An unexpected adverse drug reaction is an adverse reaction, the nature, severity, or outcome of which is not consistent with the applicable product information (such as the Investigator's Brochure for an unapproved drug or the Summary of Product Characteristics for a marketed drug).
Outline the role of WHO collaborating centre.
Answer
The WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre) plays a key role in:
- Maintaining the global database (VigiBase) of individual case safety reports.
- Developing standardized terminology and coding systems like MedDRA and WHO-ART.
- Providing technical support, training, and guidance to national pharmacovigilance centers to strengthen global drug safety monitoring.
Define daily defined doses.
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Name the design concepts for Standard MedDRA Queries content.
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Define vaccine pharmacovigilance.
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Classify Adverse events following immunization.
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Define Periodic safety updates reports.
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List out the objectives of PSURs.
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Define pharmacogenomics.
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Outline the principle guiding Pediatric product development.
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Part B
Explain the classification of ADR.
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List out what to report for ADR.
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List out any 10 basic terminologies involved in adverse medication related events with definitions.
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Explain the management adverse drug reactions.
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List out the system-organ classes and codes.
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Explain about EUDRAVIIGILANCE Medical product dictionary.
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Explain basic drug information sources.
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Develop the plan for the establishment of pharmacovigilance system in hospital.
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What is Vaccine safety surveillance? Explain in detail different types of pharmacovigilance methods used for passive and active surveillance.
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Explain briefly about cross sectional study.
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Explain briefly about case control study and cohort study.
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Explain briefly about stimulated reporting.
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Explain about pre-clinical phase.
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What is the organization and objective of ICH guidelines in Pharmacovigilance? Explain in detail good clinical practices in Pharmacovigilance studies.
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Discuss briefly about pharmacovigilance plan.
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Summarize PSUD.
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Discuss about approaches for identification of causative gene.
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Explain about drug metabolizing enzyme.
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Elaborate about drug safety in lactation.
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Discuss the future prospective in pharmacogenomics.
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