Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Sc in Clinical Research (Master of Science in Clinical Research) 2019 October 4th Semester 9697 Regulatory Affairs Paper IV Previous Question Paper
Rajiv Gandhi University of Health Sciences
IV Semester M.Sc. [Clinical Research] Degree Examination ? OCT-2019
[Time: 3 Hours]
[Max. Marks: 50]
REGULATORY AFFAIRS
PAPER IV
Section A
Q.P. CODE : 9697
Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions
(Note : Both QP Codes 9697 and 9698 are to be answered within total duration of 3 hours)
(Use separate answer booklets for section A and section B)
LONG ESSAY
1 X 20 = 20 Marks
1.
Write a note on Global Pharmaceutical Developments and Regulations. Add a note on role of
marketing authorization holders in handling drug safety for a medicinal products.
SHORT ESSAY
2 X 10 = 20 Marks
2.
Write a note on Over the counter (OTC) drugs, Ayurvedic and Homoeopathy drugs and their
safety regulation.
3.
Write about Ethics in clinical trials and Pharmacovigilance.
SHORT NOTES
2 X 05 = 10 Marks
4.
Write a note on Quality compliance in safety reporting.
5.
Regulatory inspection.
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This post was last modified on 24 June 2022