Download OU M.Pharma Pharmaceutics 1st Sem 2020 6105PCI Regulatory Affairs Question Paper

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Code No: 6105/PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharmaceutics) I-Semester (PCI) (Main & Backlog) Examination, January 2020

Subject: Regulatory Affairs

Time: 3 Hrs Max. Marks: 75

Note: Answer Any Five Questions. All Questions Carry Equal Marks

1. (a) Write a note on CFR (code of federal regulation). (8)
   

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   (b) Write a note on distribution records and master formula record. (7)
2. Explain NDA regulatory approval process. (15)
3. What are the regulatory requirements for approval of API? (15)
4. (a) Explain the objectives of CMC considerations during drug development. (9)
   (b) Enlist ICH Quality guidelines. (6)

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5. Explain the regulatory requirements of TGA (15)
6. Discuss about:
   (a) Global submission of ANDA (9)
   (b) Bio-equivalence studies for generic drugs assessment. (6)
7. Write a note on:
   

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   (a) HIPAA (6)
   (b) Pharmacovigilance safety monitoring (9)
8. Write a note on:
   (a) Investigator brochure (8)
   (b) Clinical trial protocol (7)

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