M PHARM (SEM I)
REGULATORY AFFAIRS
Question Bank
SECTION A
Attempt all questions.
1. What do you mean by ‘DMF’?
2. State Hatch-Waxman Act.
3. State the regulatory requirements for product approval of MHRA countries.
4. Define ‘CTD’ and ‘ECTD format’.
5. Mention the role of IMPD in non-clinical drug development.
6. What do you mean by global submission of ANDA?
7. Mention the functions of the Institutional Review Board.
8. Mention the steps for developing clinical trial protocols.
9. Explain the term ‘CFR’.
10. What do you mean by post approval regulatory affairs?
11. What do you mean by CMC?
12. Discuss in brief about Post Marketing Surveillance.
13. Write down the importance of Regulatory Affairs.
14. What do you mean by Distribution records?
15. Describe outsourcing BA and BE to CRO.
16. What are the phases of clinical trials?
17. Write a brief note on Hatch-Waxman Act and amendments.
18. What do you mean by ICH?
19. What is Contract Research Organization?
20. Describe the term Pharmacovigilance.
21. What are controlled documents?
22. Relate the role of SOP in pharmaceutical industry.
23. Classify different type of documents.
24. Summarize the role of institutional review board.
25. Explain the importance of code of federal regulation.
26. Summarize different phases of clinical trials.
27. Explain combination products.
28. Compare typical difference between IND and NDA
29. What is ANDA?
30. Explain the role of ICH in quality of finished product.
SECTION B
1. Describe the regulatory requirement for product approval of API and biologics.
2. State and explain the regulation for combination products and medical devices.
3. Explain the ANDA regulatory approval process.
4. Describe HIPPA as a new requirement to clinical study process.
5. Write a detailed note on Global submission of Investigational New Drug.
6. Discuss in detail about Scale up process approval changes.
7. Discuss the major component of Master formula record.
8. Explain the ANDA for generic drugs approval in US.
9. Describe the submission of DMF (Drug Master File).
SECTION C
1. Write short notes on ‘master formula record’ and ‘code of federal regulation’.
2. Describe the ways and means of US registration for foreign drugs.
3. Write short notes on ‘CTD’ and ‘ECTD format’.
4. Write a brief note on ‘non clinical drug development’.
5. Describe the formulation and working procedure of Independent Ethics Committee.
6. Write a brief note on ‘informed consent process and procedures’.
7. Write short note on ‘industry and FDA liaison’.
8. Write short notes on ‘drug master file and ‘master formula record’’.
9. Describe the ICH guidelines of ICH-Q and ICH-S.
10. Discuss the regulatory requirements for the conduction of clinical trials.
11. Write a brief note on ‘Global submission of NDA’.
12. Describe the formulation and working procedure of Institutional review board.
13. Explain the purpose and content of Investigator brochure.
14. Discuss the regulatory requirements of ROW countries for product approval.
15. How would you apply the significance of Hatch- Waxman act and amendments?
16. Outline Investigator brochure.
17. Illustrate the regulation for medical device.
18. Analyze Global submission of IND.
19. Illustrate the role of HIPAA.
20. Illustrate the Industry and FDA liaison.
21. Assess the Pharmacovigilance safety monitoring in clinical trials.
