Download OU M.Pharma Pharmaceutics 1st Sem 2018 1156PCI Regulatory Affairs Question Paper

Download OU (Osmania University) M.Pharma-Pharmaceutics (Master of Pharmacy) 1st Sem 2018 1156PCI Regulatory Affairs Previous Question Paper

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Code No. 1156/PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutics) I-Semester (PCI) (Main) Examination, February 2018
Subject: Regulatory Affairs
Time: 3 Hrs Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 (a) Explain Hatch-Waxmann Act, its benefits in generic approval. (10)
(b) Write a note on Bolar Amendment. (5)
2 Explain NDA regulatory approval process. (15)
3 What are the regulatory requirements for approval of biologics? (15)
4 Write a note on
(a) CTD and eCTD (9)
(b) ICH Quality guidelines (6)
5 Explain the regulatory requirements of TGA (15)
6 Discuss abt global submission of ANDA (15)
7 Write a note on
(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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