VELs University 2010-2nd Year M.Pharm Pharmaceutics , ,, First Sem, IPR and regulatory affairs - Question Paper

part A (10*2=20)
ans ALL THE ques.
1. What is TQC?
2. What is the importance of ISO 14000?
3. What is SUPAC?
4. Define new drug.
5. Define DTAB.
6. Define dossier.
7. What is importance of schedule N?
8. Define WTO.
9. Define GATT.
10. Define trademark.


part B (5*5=25)

11. Write short notes on training manual.
12. Classify different kinds of USFDA guidelines.
13. Write down the qualification and duties of drug inspector.
14. Describe the role of central pharmacy council and state pharmacy council.
15. Write notes on copy rights and trademarks.

part C (2*15=30)

16. Discuss in detail about constitution, history, activities, structure and organization of WHO.
17. Explain the guidelines for import of drugs according to drug and cosmetics act 1940.

Earning:   Approval pending.