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

Download OU (Osmania University) M.Pharma-Pharmaceutics (Master of Pharmacy) 1st Sem 2019 13150PCI Regulatory Affairs Previous Question Paper

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Code. No: 13150/PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutics) I-Semester (Main & Backlog) Examination,
February 2019
Subject : Regulatory Affairs
Time: 3 Hrs Max. Marks: 75
Note: Answer any Five Questions. All Questions Carry Equal Marks.
1. (a) Describe varis parts of master formula record and write its importance. 7
(b) Explain salient features of Hatch Waxman Act and its amendments. 8
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 durgs. 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
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 tline of factors that must be addressed in the clinical trial protocols as
per USFDA check list. 8
(b) Give a brief note on Pharmacovigilance and safety monitoring in clinical trials. 7
8. Write brief notes on:
a. Regulatory requirements of EU 7
b. Health Insurance Portability and Accntability Act. 8
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