This download link is referred from the post: RTMNU B-Pharm Last 10 Years 2010-2020 Previous Question Papers || Rashtrasant Tukadoji Maharaj Nagpur University
TKN/KS/16-6998
First/Second/Third/Fourth/Fifth/Sixth Semester Examination for the Degree of Bachelor of Pharmacy
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REGULATORY AFFAIRS AND INTELLECTUAL PROPERTY RIGHT
5-T-6
Time: Three Hours ] [Max. Marks: 80
N. B. : (1) Question No. 1 is compulsory.
(2) Attempt any four questions from the remaining.
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(3) Draw neat labelled diagram wherever necessary.
(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 :-
- Define 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).
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5 x 4 = 20
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- Describe the various requirements for filing ANDA 7
- Discuss in detail the various International treaties and convention on IPR. 8
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- Explain the procedure for patent filling, searching and licensing. 15
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- Write in detail on International Conference on Harmonisation (ICH). 7
- Why the drug regulatory agencies are necessary ? Explain Therapeutic Goods Administration (TGA). 8
- Define patent Act 1970, and patentability criteria and their importance. 15
- Write the FDA guidelines, contents for New drug application. 15
- Write short notes on (any three) :-
- Law related to biosimilars.
- General Agreement on Trade and Tariff (GATT).
- Indian Pharmacopoeia Commission (IPC).
- Medicines and Healthcare Regulatory Agency (MHRA).
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5 x 3 = 15
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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