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g!'b&m patent IPR and its types.
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3. Discuss the development and regulation of Biosimilars.
4. Describe about principle and elements of TQM.
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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5. Write a role of TRIPS in Regulatory Guidelines.
6. Write about the parts of patents.
7. Discuss briefly about USFDA.
8. Write a note on management tools of quality.
9. Write the role of CDSCO in Regulation Indian Pharmaceutical sector.
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10. Write in brief on major regulatories bodies in Pharmaceutical sector.
11. Write a note on new qualities tools in TQM.
12. Define and write note on trademark protection in Regulatory guidelines.
13. Brief a role of TGA.
14. Write a note on EMEA.
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This download link is referred from the post: RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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