This download link is referred from the post: RTMNU B-Pharm Last 10 Years 2010-2020 Previous Question Papers || Rashtrasant Tukadoji Maharaj Nagpur University
Faculty of Pharmacy
B.Pharm. Fifth Semester (C.B.S.) Examination
REGULATORY AFFAIRS AND INTELLECTUAL PROPERTY RIGHT
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Paper-VI (5-T-6)
[Full Marks-80 Time-Three Hours]
N.B. :— (1) Question No. 1 is compulsory.
(2) Solve any FOUR questions from the remaining.
(3) Draw neat labeled diagram wherever necessary.
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(4) Discuss the reaction, mechanism wherever necessary.
(5) Use of electronic calculator is permitted.
(6) Assume suitable data wherever necessary.
- Solve any five of the following : 5×4=20
- Write the importance of Regulatory affairs.
- Give the scope and special feature of TRIPS.
- Describe Drug Master File (DMF) and its types.
- Write short on the Therapeutic Goods Administration (TGA).
- Write role of Medicines and Health Care Regulatory Agency (MHRA).
- Elaborate the term IPR and its significance.
- Write the importance of Regulatory affairs in Pharmacy Sector.
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- Why the drug Regulatory agencies are necessary explain ICH and CDSCO. 15
- (a) Explain Hatch Waxman Act. 8
(b) Justify "Regulatory affairs regulate the Marketing". 7 - (a) Write the content of NDA. Discuss in detail the FDA guidelines for NDA application. 7
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(b) Discuss in detail the various forms of IPR. 8 - Define Investigation New Drug Administration (INDA). Give the basic component of INDA. 15
- Give detailed Account on Patentability criteria and Patent amendment according to 2002 and 2005. 15
- Write short notes on any three of the following : 5×3=15
- Compulsory Licensing
- Regulatory Strategy for post approval phase
- Patentable Subject Matter.
- USFDA.
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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