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Health Sciences
First Semester M. Pharmacy Degree Examination
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Time: Three Hours Max. Marks: 75 Marks
Regulatory Affairs
Q.P. CODE: 5130
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
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LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Discuss Regulatory requirement of NDA approval process.
- Explain the significance of documentation in BA-BE studies and add a note on outsourcing BA and BE to CRO.
- Describe the regulatory guidelines for the approval of medical devices.
- Write in detail about clinical trials and its importance in product approval process.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- What is the significance of Hatch - Waxman Act?
- Describe the working procedures of institutional review board.
- Discuss ICH guidelines on efficacy.
- Write a detailed note on Drug Master File.
- Explain the regulatory requirements of TGA.
- Give the details about IMPD.
- Write a note on Scale up process approval changes.
- Give regulatory requirements for investigational new drug submission, format and content of IND in non clinical drug development.
- Discuss about CTD and ETCD format and its usefulness in regulatory affairs.
- Write a note on HIPAA.
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