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Total No. of Questions: 8]
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Roll No .........
MPH-104T
M.Pharmacy (PCI), I Semester
Examination, December 2024
Regulatory Affairs
Time: Three Hours
Maximum Marks : 70
Note: i) Attempt any five questions.
ii) All questions carry equal marks.
1.
a) Explain Regulatory requirement of ANDA for Generic Drugs.
7
b) Discuss Surveillance of Post marketing and outsourcing of CRO.
7
2.
a) Write a detailed note on Regulation for combination products.
7
b) Enlist and explain various ICH guidelines for stability testing of Pharmaceutical.
7
3.
a) Describe different section of NDA.
7
b) Write a detailed note on the process of investigation of medicinal product dossier.
7
4.
a) What is HIPAA? Explain its role and impact in clinical trials.
7
b) Discuss in detail about the requirements for approval of conducting clinical trials.
7
5.
a) Differentiate between Review board and Independent. Ethics committee.
7
b) Define DMF. Write a detail note on various types of DMF.
7
6.
a) Explain redistribution of BE and BA to CRO.
7
b) Discuss code of federal regulation.
7
7.
a) What are the different Regulatory requirement of TGA?
7
b) Discuss Post approval regulatory affairs.
7
8.
Write short note on the following: (any two)
2×7
a) IB
b) IMPD
c) Hatch-Waxman Act