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[Max. Marks: 50]
REGULATORY AFFAIRS
PAPER IV
Section A
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)
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.
safety regulation.
3.
SHORT NOTES
2 X 05 = 10 Marks
4.
Write a note on Quality compliance in safety reporting.
Regulatory inspection.
* * * * *
[Max. Marks: 50]
REGULATORY AFFAIRS
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PAPER IV
Section A
--- Content provided by FirstRanker.com ---
Q.P. CODE : 9697Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions
--- Content provided by FirstRanker.com ---
(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)
--- Content provided by FirstRanker.com ---
LONG ESSAY1 X 20 = 20 Marks
1.
--- Content provided by FirstRanker.com ---
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
--- Content provided by FirstRanker.com ---
2 X 10 = 20 Marks
2.
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Write a note on Over the counter (OTC) drugs, Ayurvedic and Homoeopathy drugs and theirsafety regulation.
3.
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Write about Ethics in clinical trials and Pharmacovigilance.SHORT NOTES
2 X 05 = 10 Marks
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4.
Write a note on Quality compliance in safety reporting.
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5.Regulatory inspection.
* * * * *
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