Rajiv Gandhi University of Health Sciences
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M. Pharmacy Degree Examination - May/June [Year - Missing in Original Text]
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First Semester - [Subject Missing in Original Text][Time: 3 Hours] [Max. Marks: 75]
Regulatory Affairs
Q.P. CODE: 5130
Your answers should be specific to the questions asked.
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Draw neat, labeled diagrams wherever necessary.LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Explain documentation in Pharmaceutical industry with respect to Drug master file and distribution records.
- Explain pharmacovigilance safety monitoring in clinical trials.
- Give details about CMC post approval regulatory affairs.
- Explain regulatory requirements and process of ANDA.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Explain regulatory requirement in MHRA.
- Explain the stages of NDA process.
- Write a note on Health Insurance Portability and Accountability Act.
- Discuss Clinical trials in informed consent process.
- What is eCTD? Explain the advantages of electronic submission.
- Composition of Institutional Review Board (IRB). Roles and Responsibilities of the investigators.
- Give details about the ICH guidelines for safety.
- Explain Hatch-Waxman Act.
- Write detail about outsourcing of BA and BE to CRO.
- Write about regulatory guidance for approval process for Biological products.
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