Pharmaceutical regulatory sciences

Pharmaceutical regulatory sciences question bank

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Pharmaceutical regulatory sciences question bank Semester-8 B pharmacy

Pharmaceutical regulatory sciences question bank released by rguhs Bangalore. It contains all the important questions according to PCI syllabus, also contains all the questions in 10, 5, and 2 marks format.

Long Essays 10M Pharmaceutical regulatory sciences question bank

  1. Explain in detail on DMF system in India
  2. Explain the approval process and timeline for investigational new drug.
  3. Define common technical document (CTD) and electronic common technical document (eCTD). Explain different modules in CTD and eCTD.
  4. Explain the stages in development of new drug
  5. What is CTD and eCTD. Explain the different modules of CTD in detail
  6. Discuss the application and approval process for ANDA
  7. Explain the stages in drug development process
  8. Explain the regulatory approval process for New Drug Application.
  9. Discuss briefly open part and closed part of DMF.
  10. What is innovator and generic products?
  11. Explain stage in development of generic formulations
  12. Define CTD and discuss the process involved in its submission
  13. Explain the organization and functions of regulatory bodies of EU and Australia
  14. Explain the regulatory approval process for ANDA
  15. Explain different stages of drug discovery
  16. Explain the application and approval process of IND
  17. Explain different stages involved in development of new drugs
  18. Explain the organization and functions of Australia and US drug regulatory bodies
  19. Explain the application and regulatory approval process for IND
  20. Discuss the process of DMF system
  21. Explain the different modules of CTD in detail
  22. Explain the different modules of ACTD
  23. Discuss the various stages involved in generic product development
  24. Discuss approval process of NDA
  25. Explain the organization and functions of regulatory bodies of EU and Japan
  26. Discuss different stages of pre-clinical studies
  27. Discuss the application and approval process of ANDA
  28. Discuss the procedure for the export of the pharmaceutical products
  29. Explain stages in drug development process
  30. Explain different modules of ACTD.
  31. Explain the organization and functions of regulatory bodies of EU and Japan.

Short essays 5M Pharmaceutical regulatory sciences question bank

  1. Explain code for federal regulation with respect to Part 21
  2. What is CTD and eCTD? Differentiate them.
  3. Explain inclusion and exclusion in clinical trials
  4. Explain changes made to approved NDA
  5. Explain salient features of orange book
  6. Discuss the criteria for selection of human volunteers in clinical trials
  7. Explain the development of clinical trial protocols.
  8. Explain different stages in non-clinical studies.
  9. Explain the application and approval process for IND
  10. Explain the organization structure and functions of Japan drug regulatory body
  11. Explain the stages of drug discovery process
  12. Discuss the importance of orange book in development of generic product
  13. Explain the application and approval of ANDA
  14. Write briefly on clinical trial protocol
  15. Explain the salient features of pharmacovigilance
  16. Explain the differences between brand and generic products
  17. Explain organization structure and functions of Europe drug regulatory authority
  18. Write an overview on ACTD
  19. Explain the non -eCTD electronic submission form (NeeS).
  20. Explain the organization and functions of CDSCO
  21. Explain the salient features of purple book.
  22. Define clinical trial and explain Phase II
  23. Explain the constitution and functions of Institutional Review Board
  24. Regulatory approval process for IND
  25. Explain the salient features of Pharmacovigilance
  26. Write a note on ANDA and its approval process
  27. Differentiate between innovator and generic products
  28. Explain independent ethics committee
  29. Write a note on different modules of DMF
  30. Discuss salient features of orange book
  31. Discuss Phase I clinical trials
  32. Discuss briefly stages of drug discovery process
  33. Differentiate innovator and generic products
  34. Explain monitoring of clinical trials
  35. Write briefly on changes made to approved ANDA
  36. Write an overview on ACTD
  37. Explain the eCTD.
  38. Explain code of federal regulation.
  39. Write a note on ANDA and its approval process.
  40. Explain regulatory change over from NDA to ANDA
  41. Define and explain ethical principles of informed consent process
  42. Explain salient features of purple book
  43. Explain independent ethics committee
  44. Discuss organization structure and functions of regulatory authority for EU
  45. Explain regulatory approval process of IND
  46. What is clinical trial protocol? Write a note on informed consent process.
  47. Write briefly on organization structure and functions of USFDA.
  48. Explain the salient features of orange book.
  49. Define clinical trial and explain Phase III
  50. Explain the constitution and functions of Institutional Review Board
  51. Write a note on 21 CFR
  52. Write different modules of ACTD
  53. Explain the importance of pharmacovigilance
  54. Explain organization structure and functions of drug regulatory authority of Australia
  55. Explain the salient features of pharmacovigilance
  56. Explain the organization structure and functions of CDSCO
  57. Explain the working procedure for preparation of clinical trial protocol
  58. Explain the application and approval of IND
  59. Explain the constitution and functions of clinical review board
  60. What is CTD and explain different sections of CTD
  61. Discuss the importance of orange book
  62. Explain organization structure and functions of USFDA
  63. Explain different changes made to an approved NDA
  64. Explain CTD and eCTD
  65. Explain inclusion and exclusion in clinical trials
  66. Explain code for federal regulation with respect to Part 21
  67. Explain changes made to approved NDA
  68. Explain salient features of purple book
  69. Explain the organization and functions of CDSCO
  70. Explain briefly generic product development process
  71. Explain the formation and functions of institutional review board
  72. Briefly write a note on submission of DMF
  73. Define and differentiate CTD and eCTD
  74. Explain the Phase II clinical trials
  75. With example differentiate between brand and generic products
  76. Explain the process involved in shifting from NDA to ANDA
  77. Explain the importance of 21 CFR
  78. Explain the procedure for the export of generic formulations
  79. Explain the inclusion and exclusion criteria in clinical trials
  80. Discuss the importance of pharmaceutical regulatory affairs in industry
  81. Explain the safety monitoring in clinical trials
  82. Explain the organization structure and functions of Australian drug regulatory body
  83. Explain code of federal regulation
  84. Write briefly on the development of clinical trial protocol
  85. Explain the salient features of orange book
  86. Explain the formation and functions of independent ethics committee
  87. What is DMF? Explain the contents of DMF
  88. Explain organization structure and functions of drug regulatory authority of Japan
  89. Explain the ethical principles of informed consent form for clinical trial process
  90. Concept of generic drug product development.

Short essays 2M Pharmaceutical regulatory sciences question bank

  1. Purple book
  2. Enlist different applications used for approval in EU
  3. Pre-clinical studies
  4. Organogram of CDSCO
  5. Difference between brand and generic products
  6. Difference between NDA and ANDA
  7. Enlist the stages of drug development process
  8. Name the regulatory authorities of India, US, EU and Australia
  9. Write a note on Phase II
  10. List out the items of module III in ANDA
  11. Exclusion criteria in clinical trials
  12. Constitution of Australian authority
  13. Export of generic products
  14. Process of informed consent
  15. Phase II clinical trials
  16. Significance of pharmacovigilance
  17. Role of regulatory affairs in pharmaceutical industry
  18. eCTD
  19. CFR
  20. Functions of US regulatory authority
  21. Functions of Japan drug regulatory authority
  22. Importance of DMF
  23. Modules of CTD
  24. Non-clinical studies
  25. Functions of CDSCO
  26. Non – eCTD submission form
  27. Informed consent form
  28. Purple book
  29. Constitution of IRB
  30. Module III in eCTD
  31. Functions of Japan drug regulatory body
  32. Salient features of DMF
  33. Phase II clinical trials
  34. Export of generic products
  35. Institutional Review Board
  36. Safety monitoring in clinical trials
  37. Open parts of DMF
  38. Objectives of regulatory affairs
  39. Differentiate innovator and generic products
  40. Functions of US FDA
  41. Orange book
  42. Safety monitoring in clinical trials
  43. Phase I
  44. Importance of DMF
  45. Modules of ACTD
  46. Non-clinical studies
  47. Mention the general list of 21 CFR
  48. Difference between CTD and eCTD
  49. Give examples for brand and the respective generic products
  50. Constitution of CDSCO
  51. Objectives of regulatory affairs department in pharma industry
  52. Enlist the types of DMF
  53. Non-clinical studies
  54. Pharmacovigilance
  55. Differentiate innovator and generic products
  56. Modules in ACTD
  57. Functions of US FDA
  58. What is clinical trial protocol?
  59. Write a note on IND
  60. Enlist the functions of CDSCO
  61. What is DMF? Enlist the types
  62. NDA vs ANDA
  63. Enlist the different applications used for approval in USFDA
  64. Role of regulatory affairs personnel in pharmaceutical industry
  65. Briefly write on Phase I studies
  66. Importance of purple book
  67. Informed consent form
  68. Mention the general list of 21 CFR
  69. Non-clinical trials
  70. Inclusion criteria for clinical trials
  71. Phase III studies
  72. Write a note on generic products
  73. 21 CFR
  74. Enlist the functions of TGA
  75. Open parts of DMF
  76. Define the term TGA and EMEA
  77. List out the parts in module III
  78. Non-clinical studies
  79. Define regulatory affairs
  80. Difference between NDA and ANDA
  81. List out the items in module III in ANDA
  82. Write a brief note on 21 CFR
  83. Define regulatory affairs
  84. Enlist the functions of Australian drug regulatory authority
  85. What is clinical trial protocol?
  86. Differentiate between generic and innovator products
  87. Enlist parts of DMF
  88. Modules of ASEAN common technical document
  89. Exclusion criteria in clinical trials
  90. Generic vs Innovator
  91. Phase II clinical trials
  92. Modules of ASEAN common technical document
  93. Safety monitoring in clinical trials
  94. Monitoring clinical trials
  95. Define the term USFDA and EMDA
  96. Pre-clinical studies
  97. Salient features of purple book
  98. Define the term IND and NDA
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