Download RTMNU B.Pharma 5th Semester 2015 Winter Regulatory Affairs and Intellectual Property Right Question Paper

Download RTMNU (Rashtrasant Tukadoji Maharaj Nagpur University) B.Pharma (Bachelor of Pharmacy) 5th Semester 2015 Winter Regulatory Affairs and Intellectual Property Right Question Paper

NTK/KW/15/6998
Faculty of Pharmacy
B.Pharm. Fifth Semester (C.B.S.) Examination
REGULATORY AFFAIRS AN D INTELLECTUAL
PROPERTY RIGHT
Paper?VI (5-T-6)
Time?Three Hours] [Full Marks?80
N.B. :? (1) Question N0. 1 is compulsory.
(2) Solve any FOUR questions from the remaining.
(3) Draw neat labeled diagram wherever necessary.
(4) Discuss the reaction, mechanism wherever
necessary.
(5) Use of electronic calculator is permitted.
(6) Assume suitable data wherever necessary.
1. Solve any five of the following : 5X4=20
(1) Write the importance of Regulatory affairs.
(2) Give the scope and special feature of TRIPS.
(3) Describe Drug Master File (DMF) and its types.
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(4)
(5)
(6)
(7)
Write short on the Therapeutic Goods Administration
(TGA).
Write role of Medicines and Health Care Regulatory
Agency (MHRA).
Elaborate the term IPR and its signi?cance.
Write the importance of Regulatory a?airs in Pharmacy
Sector.
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 ofNDA. Discuss in detail the FDA
guidelines for NDA application. 7
(b) Discuss in detail the various forms of IPR. 8
De?ne 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
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7. Write short notes on any three of the following :
5X3=15
(1) Compulsory Licensing
(2) Regulatory Strategy for post approval phase
(3) Patentable Subject Matter.
(4) USFDA.
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