Wednesday, January 25, 2023

Dr. A.P.J. Abdul Kalam University M PHARMACY I SEM (ALL BRANCH) Regulatory Affairs (MPH 104T) Dec 2020 Question Paper

Dr. A.P.J. Abdul Kalam University

Master of Pharmacy (Pharmaceutics)

First Semester Main Examination, Dec-2020

Regulatory Affairs (MPH 104T)

Time: 3:00 Hrs Max Marks 75

Note: Attempt any five questions. All questions carry equal marks.

Q.1 (a) NDA approval process.

(b) Post marketing surveillance.

Q.2 (a) Write the ICH guidelines for stability testing of pharmaceutical.

(b) Write investigation medicinal product dossier.

Q.3 (a) Describe Pharmacovigilance safety monitoring in clinical trials.

(b) Write note on clinical trial protocols.

Q.4 (a) Write constitution and composition of state pharmacy councils.

(b) Explain the trade mark filling procedure.

Q.5 (a) Write salient features of Indian Patent Act.

(b) Post approval regulatory affairs.

Q.6 (a) Enlists various documents of clinical trial protocol.

(b) Write short note on IND and orphan drugs.

Q.7 (a) Write the concept of innovator and generic drug.

(b) Write note on CFR.

Q.8 Write short note on –

(a) Drug Master File

(b) ISO

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