This download link is referred from the post: RTMNU B-Pharm Last 10 Years 2010-2020 Previous Question Papers || Rashtrasant Tukadoji Maharaj Nagpur University
B.Pharm Fifth Semester (C.B.S.) Examination
REGULATORY AFFAIRS AND INTELLECTUAL PROPERTY RIGHT
Paperβ6 (5-T-6)
Time : Three Hours] [Maximum Marks : 80
N.B. :β (1) Q. No. 1 is compulsory.
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(2) Attempt any FOUR questions from the remaining.
(3) Draw neat labeled diagram wherever necessary.
(4) Assume suitable data wherever necessary.
(5) Use of electronic calculator, excluding programmable calculator is permitted.
- Solve any FIVE :β
- (a) Enlist various International Treaties and Conventions on IPR. Mention Global Drug Regulatory agencies.
- (b) Differentiate between Generics and Biosimilars.
- (c) Give different types of Drug Master File (DMF).
- (d) Explain how Drug Regulatory Affairs department acts as a link between pharmaceutical industry and regulatory agency.
- (e) Give procedure of registering trade marks.
- (f) Write about role and responsibility of CDSCO. 5Γ4=20
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- (a) Give an account on Amendments to Indian Patent Act, 1970. 7
(b) What do you mean by INDA ? What are the contents and format of IND application ? 8 - (a) What are the various stages of filing patent through PCT ? Mention advantages of PCT. 7
(b) Define New Drug. Give an account on various stages in filing New Drug Application. 8 - (a) Describe the role and responsibilities of Drug regulatory agency. 7
(b) Give an account on Hatch-Waxmann Act, 1984. Describe various requirements for filing Abbreviated New Drug Application (ANDA). 8 - (a) Define the terms :β
- (i) Patentability Criteria
- (ii) Compulsory Licensing.
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(b) Give objectives and principles of Good Clinical Practice guideline (GCP). Add a note on Declaration of Helsinki. 7 - (a) What do you mean by Common Technical Document (CTD) ? Give objectives and functions of ICH. 8
(b) Give an account on Intellectual Property Laws in India. Add a note on copyright. 7 - Write short notes on (any THREE) :β
- (a) Patent Infringement
- (b) GATT and WTO
- (c) Phases of Drug Development
- (d) Good Manufacturing Practice guideline (GMP). 5Γ3=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