Rajiv Gandhi University of Health Sciences
Second Semester M. Pharmacy
Pharmacognosy
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Time: Three Hours Max. Marks: 75 Marks
Regulatory Affairs
Q.P. CODE: 5166
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
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LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- What is intellectual property? Discuss different conditions to be satisfied by an invention to be patentable.
- What are the principles and elements of TQM? Add a note on tools and techniques of quality.
- Discuss in detail regulatory requirements for Biosimilars submission.
- Discuss USFDA regulatory requirements for contract research organization.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- What is the significance of patents in pharmaceutical industry?
- Explain the role of WIPO.
- What are regulations in trademark protection?
- State the objective and function of Central Drugs Standard Control Organization.
- Discuss Regulatory requirements of EU.
- Write a short note on concept of total quality management.
- Write a note on post approval regulatory affairs in Biosimilars.
- Explain EMEA regulatory requirements.
- Discuss different parts of patents.
- Write a note on patent of addition.
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