Download RGUHS M.Pharm 2019 Jan 1st Year 5111 Drug Regulations And Intellectual Property Rights Question Paper

Rajiv Gandhi University of Health Sciences

First Semester M. Pharm Degree Examination

FirstRanker.com

--- Content provided by⁠ FirstRanker.com ---

[Time: 3 Hours] [Max. Marks: 75]

Drug Regulations and Intellectual Property Rights

Q.P. CODE: 5111

Your answers should be specific to the questions asked.

Draw neat, labeled diagrams wherever necessary.

--- Content provided by⁠ FirstRanker.com ---

LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks

1. Explain the procedure for patenting an invention.
2. Elaborate the consequences of GATT.
3. Describe the types of trademarks.
4. Explain the role of TGA and ANVISA in controlling drug regulations.

--- Content provided by‍ FirstRanker.com ---

SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks

1. Explain the benefits of patent system.
2. Explain different types of inventions for which patents can be secured.
3. Explain the features of the TRIPS agreement.
4. What are the functions of WIPO?

--- Content provided by​ FirstRanker.com ---

5. Describe the types of intellectual property rights.
6. Explain the importance of copyright.
7. Describe objectives, responsibilities, scope, and functions of USFDA.
8. Explain the role of MCC.
9. Describe the regulatory requirements for contract research organization.

--- Content provided by‍ FirstRanker.com ---

10. Explain the regulations for biosimilars.