Download OU M.Pharma Pharmaceutics 1st Sem 2019 13150PCI Regulatory Affairs Question Paper

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FACULTY OF PHARMACY

M. Pharmacy (Pharmaceutics) I-Semester (Main & Backlog) Examination, February 2019

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Subject : Regulatory Affairs

Time: 3 Hrs Max. Marks: 75

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

1. (a) Describe various parts of master formula record and write its importance. 7
   (b) Explain salient features of Hatch Waxman Act and its amendments. 8

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2. Enlist different sections of NDA and Write a note on NDA approval process. 15
3. (a) Explain regulatory requirements of US registration for foreign drugs. 8
   (b) Explain SUPAC guidelines specific to manufacturing changes 7
4. (a) Describe the objectives of harmonization guidelines. Enlist ICH quality guidelines. 10
   (b) Explain the objectives of CMC considerations during drug development. 5

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5. (a) Explain the regulatory requirement for biologics product approval. 8
   (b) What is the purpose of Investigator’s Brochure? Give a brief note on the Information to be filled in each part of the IB. 7
6. (a) Write a note on eCTD. 7
   (b) Write different designs of BE studies for Generic drugs assessment. 8
7. (a) Give an outline of factors that must be addressed in the clinical trial protocols as per USFDA check list. 8
   

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   (b) Give a brief note on Pharmacovigilance and safety monitoring in clinical trials. 7
8. Write brief notes on:
   1. Regulatory requirements of EU 7
   2. Health Insurance Portability and Accountability Act. 8

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