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Download RGUHS M.Pharm 2018 May 2nd Year 5166 Regulatory Affairs II Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2018 May (Master of Pharmacy) 2nd Year 5166 Regulatory Affairs II Previous Question Paper

This post was last modified on 11 June 2021

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


Rajiv Gandhi University of Health Sciences

Second Semester M. Pharm Examination

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

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Regulatory Affairs - II

Q.P. CODE: 5166

Your answers should be specific to the questions asked.

Draw neat, labeled diagrams wherever necessary.

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

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  1. Describe in detail about parts of patents and filling of patents.
  2. Explain continuous improvement and learning tools of TQM.
  3. Describe the regulatory requirements for contract research organization.
  4. Write the detail about regulation of Indian Pharmaceutical sector with respect to WHO.

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

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  1. Write a note on WIPO.
  2. Write a note on MHRA.
  3. Write the function of USFDA Guidelines.
  4. Write a note on trademark protection in Regulatory guidelines.
  5. Write a note on need of patent.
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  7. Discuss about post-market Data Regulation in Biosimilar.
  8. Write the principle of TQM.
  9. Write note on Biosimilar Regulation for clinical study.
  10. Write a note on non-obviousness patent.
  11. What is ANVISA.
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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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