RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
First Semester B.Pharmacy Degree Examination
[Time: 3 Hours] [Max. Marks: 75]
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Regulatory Affairs
Q.P. CODE: 5130
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
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- Write salient features of Hatch Waxman act and write note on orange book.
- Explain briefly USFDA regulatory requirements for NDA product approval.
- Explain ICH Q8, Q9 and Q10.
- Discuss the in vitro drug product performance of USFDA.
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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- Salient feature of EU guidelines
- Importance of Health insurance portability and accountability act
- General principles in safety monitoring in clinical trials.
- Explain the procedure for Informed consent in clinical trials.
- Which are ROW countries?
- Duties and responsibilities of Institutional review board
- Post approval regulations of MHRA
- Explain ICH Q10.
- General guidelines of out sourcing BA and BE to CRO
- What are set of safety guideline of ICH?
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