IMP QUESTION
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Regulatory Affair(MAT104T) GTU SEM – 1 IMP QUESTIONS
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Based on the analysis of the GTU 2018- 23 Year exam papers, the top 25 most frequently appearing questions are as follows:
1. Explain IND submission for worldwide.
2. Write a note on ANDA. Explain PARA I to IV filling in ANDA.
3. Describe CFR 21 (code of federal regulation) in detail.
4. Define CTD and eCTD. Explain in detail.
5. Discuss Pharmacovigilance programs of USFDA and MHRA.
6. Discuss outsourcing of BA and BE to CRO.
7. Explain guidelines of ICH – Q.
8. Give importance of CRO. What about outsourcing of BA & BE studies to CRO?
9. Describe objectives, provision and loopholes of the Hatch-Waxman Act.
10. Define DMF. Classify types of DMF. Discuss type II DMF.
11. Describe goal of ANDA. Discuss ANDA review process.
12. Enlist contents of IND. Describe withdrawal process of IND. Describe the investigator’s brochure for IND.
13. What is MFR? Describe component of MFR.
14. Discuss ICH guidelines for Pharmaceutical Development.
15. Explain regulatory requirements of TGA. Compare and Contrast: TGA and MHRA.
IMP QUESTION
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16. Describe Hatch-Waxman act and its amendments in detail.
17. Explain PARA I to IV filling in ANDA.
18. Write note on clinical protocol at institutional level.
19. Discuss regulatory requirements for Investigational Medicinal Product Dossier (IMPD).
20. Explain pharmacovigilance safety monitoring in clinical trials.
21. Discuss levels of post-approval changes.
22. Describe specific requirements and contents of an NDA.
23. Explain terms: i) CMC ii) Biowavier.
24. Explain the necessity and importance of ICH M4 guidelines.
25. Discuss regulatory requirements for Investigational Medicinal Product Dossier (IMPD).
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These questions have appeared frequently across the GTU 2018- 23 Year exam papers, indicating their importance and likelihood of being included in future exams.
Note: –
• 1 to 20 Most IMP
• 21 to 25 Extra for Toppers