RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Second Semester Examination
[Time: 3 Hours] [Max. Marks: 75]
Biologicals Regulations
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Q.P. CODE: 5146
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
- Explain the Good Manufacturing Practice guidelines for biologics in India?
- Write about the requirements for Plasma Master File (PMF) certification.
- Describe the regulatory guidance for the development and approval of biosimilar products in the US.
- What are the requirements for marketing authorization of biosimilar medicines in European Union?
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Describe the principles for the development of similar biologics in India.
- Differentiate between biological and generic drug.
- Write a note on International Haemovigilance Network.
- Give the labeling requirements for blood and blood products in US.
- Discuss the stability and safety requirements for biologics in EU.
- Explain the European Union marketing authorization for vaccines.
- Write the regulatory requirements for blood components in India.
- Write a note on Centre for Biologics Evaluation and Research (CBER).
- Explain in brief about quality assessment of vaccines in US.
- What are the post marketing data requirements for biologics in India?
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