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NKT/KS/17/6569
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B. Pharm. Fifth Semester (C.B.S.) Examination
REGULATORY AFFAIRS AND INTELLECTUAL PROPERTY RIGHT
Paper-6 (5-T-6)
Time: Three Hours]
[Maximum Marks : 80
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N.B. :- (1) Question No. 1 is compulsory.
(2) Attempt any FOUR questions from the remaining.
(3) Assume suitable data wherever necessary.
(4) Discuss the reaction, mechanism wherever necessary.
(5) Use of electronic calculator, excluding programmable calculator is permitted.
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- Solve any FIVE of the following : 5×4=20
- Write short note on -Importance of Regulatory Affairs.
- Describe functions of Regulatory Affairs.
- Discuss in brief -Importance of IPR.
- Describe Copyrights.
- Define patent, discuss importance of patent.
- Write short note on Criteria for granting a patent.
- Write short note on Trademarks.
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- Write detail account on regulatory strategy during the pre-clinical development phase. 7
- Explain – Regulatory strategy during the clinical development phase. 8
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- Write detail account on drug regulatory authority and agencies in India and US. 15
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- Explain Content and format of Investigational New Drug Application. 7
- Discuss in detail New Drug Application. 8
- Write detail account on patent procedure, filing, search and licensing. 15
- Discuss in detail Abbreviated New Drug Application (ANDA) and Types of Drug Master File (DMF). 15
- Write short notes on (any three) : 5×3=15
- Trade Related Intellectual Property Rights
- Hatch-Waxman Act
- Compulsory Licensing
- World Trade Organisation (WTO).
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This download link is referred from the post: RTMNU B-Pharm Last 10 Years 2010-2020 Previous Question Papers || Rashtrasant Tukadoji Maharaj Nagpur University