OU M.Pharm Question Papers Last 10 Years 2010-2020 || Osmania University
Code No. 1156/PCII
FACULTY OF PHARMACY
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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.
- (a) Explain Hatch-Waxmann Act, its benefits in generic approval. (10)
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(b) Write a note on Bolar Amendment. (5) - Explain NDA regulatory approval process. (15)
- What are the regulatory requirements for approval of biologics? (15)
- Write a note on:
(a) CTD and eCTD (8)--- Content provided by FirstRanker.com ---
(b) ICH Quality guidelines (7) - Explain the regulatory requirements of TGA (15)
- Discuss about global submission of ANDA (15)
- Write a note on:
(a) HIPAA (8)--- Content provided by FirstRanker.com ---
(b) Pharmacovigilance safety monitoring (7) - Write a note on:
(a) Investigator brochure (8)
(b) Clinical trial protocol (7)
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