B pharmacy 8 sem Pharmacovigilance questions bank

Pharmacovigilance questions bank, this questions bank is released by rguhs Bangalore, it contains all the important questions covered by the syllabus of pharmacovigilance b pharmacy 8 sem.

 Long Essays 10 marks

  1. Define pharmacovigilance. Discuss in detail reporting and management of ADRs along with causality assessment scales
  2. Discuss in detail setting up of a  pharmacovigilance system in hospital 
  3. What do you meant by Vaccine Pharmacovigilance. Discuss in detail Passive and active surveillance for vaccine safety  study
  4. Define Adverse Drug Reactions. Classify ADRs with suitable examples. Explain the mechanism of Type-B adverse drug reactions
  5. Explain in detail comparative observational  researches as tools for vaccine safety studies
  6. Discuss in detail establishment and operation of drug safety department in pharmaceutical industry.        
  7. Define ADR. Discuss in detail about the detection and reporting of ADR
  8. Discuss in detail about spontaneous case reports and case series
  9. Explain the drug information sources and give the specialized  resources or ADR
  10. Enumerate the different method of causality  and severity assessment of ADR and explain the WHO scale
  11. Explain the establishing pharmacovigilance program in the hospital
  12. Discuss in details of passive surveillance and active surveillance. Explain the drug event monitoring program
  13. Discuss the causality assessment of ADR. Explain Narinjo scale
  14. Discuss in detail of Cohort and case control study
  15. Explain  the applications of MedDRA and standard MedDra queries
  16. Discuss in detail basic and specialized drug information resources in pharmacovigilance
  17. What is Vaccine safety surveillance? Explain in detail different types of pharmacovigilance methods used for passive and active surveillance.
  18. Define adverse drug reactions. Discuss in detail causality, severity and seriousness assessment of ADRs
  19. Discuss in details vaccine safety surveillance
  20. Define Pharmacovigilance. Discuss the role of Pharmacist in detection,reporting and management of ADRs in hospital
  21. Explain in detail MedDRA and WHO-AR
  22. What are the objectives of pharmacovigilance programme of India. .Explain in details various methods of monitoring,detecting and reporting of ADRs
  23. Discuss  various factors to be considered  for setting up Pharmacovigilancecentre in industry and  in hospital
  24. Explain in details spontaneous case reports and case series as pharmacovigilance methods for vaccine safety surveillance.
  25. Explain scope of pharmacovigilance and methods of ADR reporting in India
  26. Discuss in detail setting up of a  drug safety department  in   Industry
  27. What do you meant byVaccinePharmacovigilance..Compare and contrast various observational methods for vaccine safety study.

Short Essays  ( 5 marks)

  1. Discuss in details preventability assessment of ADRs
  2. Estabilishing National  pharmacovigilanceprogramme
  3. Scope of MedDRA and  Clinical research organization
  4. Advantages and disadvantages of case control studies in  vaccine safety evaluation
  5. Discuss in details clinical trials for  drug safety data generation
  6. Write a note on Good clinical practice in pharmacovigilance studies
  7. Mention the importance aspects of ICH  guidelines for expedited reporting
  8. Drug safety evaluation in geriatric and pediatric populations
  9. Discuss Naranjo’S and WHO  causality assessment scales
  10. Idiosyncratic and hypersensitivity reaction What are the basic guidelines for coding as per ICD-10 system
  11. Define vaccine. Explain reasons for vaccination failure
  12. Explain Pre- marketing and Post marketing clinical trials.
  13. Role of Pharmacist   in management of ADRs
  14. Write a note on clinical trial regulations in India
  15. Explain predisposing factors of adverse drug reactions
  16. Write a note on ATC classification of drugs
  17. How will you investigate AEFI
  18. Role o CDSCO in pharmacovigilance
  19. Write a note on post approval expedited reporting
  20. Write a note on pharmacovigilance of India(PvPI)
  21. What are the prerequisite for setting up pharmacovigilancecentre in a hospital
  22. Write a note on risk benefit assessment of vaccine
  23. Writ a note on post approval expedited reporting
  24. Describe organization and objective of ICH
  25. Writ a note on Schedule Y
  26. What are the requirements of ICSR
  27. What is periodic safety update reports
  28. Discuss in detail mechanisms of type A adverse drug reactions
  29. GCP-ICH guidelines
  30. Write a note on targeted clinical investigations
  31. What are the factors to be considered for the drug safety evaluation in Geriatrics
  32. Write a note on Cross-sectional study
  33. Discuss in detail drug safety evaluation in  pregnant and lactating women
  34. what are the requirements of individual case safety reports
  35. Discuss in detail WHO drug dictionary and coding in pharmacovigilance
  36. Explain periodic safety update reports (PSURs)Importance of safety monitoring of drug
  37. Severity assessment of ADR
  38. Establishing national pharmacovigilance program
  39. Operation of drug safety department in industry
  40. ATC classification of drugs
  41. Give the different types ADE on vaccine
  42. Explain safety data generation
  43. Functions of CDSCO in pharmacovigilance
  44. Write a note on drug safety evaluation in paediatric population  
  45. Write a note on GCP guidelines in pharmacovigilance
  46. Define and classify Adverse drug reactions 
  47. Discuss the importance of  effective communication in Pharmacovigilance
  48. Write a note on international classifications of  diseases
  49. Discuss briefly preclinical phase of safety data generation  
  50. What are the specialized drug information resources for ADRs
  51. Explain individual case study reports(ICSR)   
  52. Importance of safety monitoring of Medicines  
  53. Explain briefly Schedule Y of  D&C  Act 
  54. Write a note on  Expedited reporting and post approval expedited reporting
  55. Discuss  various methods used to detect and monitor ADRs with its merits and demerits
  56. How will you communicating  vaccine safety issues with healthcare facilities and Media
  57. Write a note on Med DRA
  58. Discuss in detail post approval phase of drug safety data generation
  59. What are the  basic drug information resources for ADRs
  60. Organization and functions of ICH
  61. Discuss briefly  scales used for predictability and preventability assessment of ADRs
  62. Describe briefly on WHO international drug monitoring program
  63. Explain the predictability and preventability of ADR
  64. Explain the adverse event following immunization
  65. Write a note on Post approval phase
  66. Mention the role of contract research organization
  67. Write a  note on periodic safety reports
  68. Describe standard Med DRA queries
  69. Describe the drug safety evaluation in Geriatrics
  70. Write a note on ICH
  71. Describe Safety monitoring of medicine
  72. Explain international classification of disease
  73. Describe briefly on good clinical practice in pharmacovigilance study
  74. Individual case safety reports
  75. Describe organization and objective of ICH
  76. Short note on functions of contract research organization
  77. Explain CIOMS requirements for ADR reporting
  78. Explain immunization safety surveillance system
  79. Write a note on predictable ADR

Short Answers  (2 marks)

  1. Different software used in ADR
  2. Define PvPI
  3. What is Drug event monitoring
  4. Give the application of Defined daily dose in pharmacovigilance
  5. Prescription event monitoring
  6. Requirements for CIOMS form
  7. Reporting ADR
  8. Importance of vaccine safety
  9. What is preclinical phase
  10. Vaccination failure
  11. Give examples of ADRs due to genetic defect in distribution
  12. What are the factors to be considered while evaluating drug safety in Geratrics
  13. Eudravigilance
  14. List out applications of causality assessment
  15. Mention the  levels of ATC
  16. Targeted clinical investigations
  17. Reasons for vaccine failures
  18. What is AEFI ?
  19. Objectives of ICH
  20. Mention few primary sources of drug information
  21. Importance of Pharmacogenomics
  22. Sentinel sites as  active surveillance
  23. What is teratogenicity  .Give examples
  24. What is phase II of clinical trials
  25. Mention few predictable adverse drug reactions
  26. Genetically determined toxicities
  27. VSD
  28. Advantages and disadvantages of passive surveillance vaccine safety
  29. Importance of post approval expedited reporting
  30. ICH guidelines for pharmacovigilance planning
  31. Goals of CDSCO(India)
  32. Genetic related ADRs with examples
  33. Databases for pharmacovigilance study
  34. What is PSUR and DSUR
  35. What  is primary purpose of ICH?
  36. List few drugs causing teratogenicity ?
  37. What do you meant by Dechallenge and rechallenge
  38. List out types of products in WHO-drug dictionary
  39. List out steps involved in vaccine pharmacovigilance
  40. Advantages Case series for vaccine safety study
  41. What are the limitations of pre clinical phases
  42. Explain the objectives of ICH
  43. What is post marketing safety?
  44. Organization of ICH
  45. List out the role of  CDSCO(India) and CIOMS
  46. What is pharmacogenomics?
  47. What is CIOMS form
  48. Write a note on Vaccine safety datalink
  49. Coding for ADR
  50. Define Vigiflow, WHO-ADR, ADEWhat is AEFI ?
  51. Mention the objectives of ICH
  52. Genetic polymorphism
  53. Define  Pharmacogenomics
  54. Sentinel sites
  55. Classify ADRs according to severity
  56. Importance of  using standard dictionary
  57. List out factors affecting adverse effects of vaccine
  58. Define safety surveillance
  59. Spontaneous case reports
  60. What are the minimum criteria required for a valid Report?
  61. What are the three  minimum GCP principals
  62. Responsibilities of CDSCO(Indian)
  63. Give examples of  Pharmacokinteic ADRs
  64. List four drugs contraindicated in pregnant and lactating women
  65. What is teratogenicity and idiosyncrasy
  66. What is phase IV of clinical trials
  67. Defined daily doses
  68. Genetically determined toxicities
  69. VSD
  70. Factors affecting AEFI surveillance
  71. What is CIOMS working groups
  72. What are the main guidelines of ICH
  73. Give two examples of ADRs due to genetic defect in metabolism
  74. VERS
  75. Safety  Signals
  76. What is phase .III of clinical trials
  77. How will you calculate DDD?
  78. Objectives of CDSCO(India)
  79. Stimulated reporting
  80. Classification of ADR
  81. Defined daily doses
  82. Write a note on Sentinel sites
  83. Role of CDSCO
  84. Vaccination failure
  85. Factors affecting immunization safety
  86. Individual case safety reports
  87. Give two example for Genetics related ADR
  88. Write a note on volunteers involved in clinical phases
  89. Short note on CIOMS form
  90. Write a note on anaphylactic reaction
  91. Write a note on Probable, Predictable
  92. Drug safety crisis management
  93. Give the importance of VARES
  94. Cross sectional studies
  95. Periodic safety update reports
  96. Classification of ADE
  97. Drug safety on geriatrics
  98. Define pharmacogenomics
  99. Write a note on Eudravigilance

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