Download RTMNU (Rashtrasant Tukadoji Maharaj Nagpur University) B.Pharma (Bachelor of Pharmacy) 5th Semester 2016 Summer Regulatory Affairs and Intellectual Property Right Question Paper
First/Second / Third/ Fourth/Fifth / Sixth
Semester Examination for the Degree of
Bachelor of Pharmacy
REGULATORY AFFAIRS AND INTELLECTUAL
Time : Three Hours ]
N. B.
PROPERTY RIGHT
5 ? T ? 6
[ Max. Marks : 80
Question No. 1 is compulsory.
Attempt any four questions from the remaining.
Draw neat labelled diagram wherever necessary.
Discuss the reaction, mechanism wherever
\_/\_/\_/\_/
(1
(2
(3
(4
necessary.
(5) Use of electronic calculator is permitted.
(6) Assume suitable data wherever necessary.
1. Solve any ?ve of the following :?
(a)
(b)
(C)
(d)
(e)
(f)
(g)
De?ne patent. Write the various criteria for granting
the patent.
What is the role of Medicines and Health Care
Regulatory Agency (MHRA).
Explain Hatch ? Waxman Act.
Describe the term Intellectual property rights.
Mention the concept and format of an IND
application.
Write short note on New drug application.
Describe Role of World Trade Organization (WTO).
5 X 4 = 20
TKN/KS/16?6998 Contd.
5??
.U?
(a)
(b)
Describe the various requirements for ?ling ANDA
7
Discuss in detail the various International treaties
and convention on IPR. 8
Explain the procedure for patent filling, searching and
licensing. 15
(a)
(b)
Write in detail on International Conference on
Harmonisation (ICH). 7
Why the drug regulatory agencies are necessary ?
Explain Therapeutic Goods Administration (TGA).
8
De?ne patent Act 1970, and patentability criteria and their
importance. 1 5
Write the FDA guidelines, contents for New drug
application. 15
Write short notes on (any three) :?
(a)
(b)
(C)
((1)
Law related to biosimilars.
General Agreement on Trade and Tariff (GATT).
Indian Pharmacopoeia Commission (IPC).
Medicines and Healthcare Regulatory Agency
(MHRA). 5 X 3 = 15
TKN/KS/16?6998 2 430
This post was last modified on 19 January 2020