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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- Describe in detail about parts of patents and filling of patents.
- Explain continuous improvement and learning tools of TQM.
- Describe the regulatory requirements for contract research organization.
- 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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- Write a note on WIPO.
- Write a note on MHRA.
- Write the function of USFDA Guidelines.
- Write a note on trademark protection in Regulatory guidelines.
- Write a note on need of patent.
- Discuss about post-market Data Regulation in Biosimilar.
- Write the principle of TQM.
- Write note on Biosimilar Regulation for clinical study.
- Write a note on non-obviousness patent.
- What is ANVISA.
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