RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Previous Year Question Paper
ESSAY (Answer any Three) Draw neat, labeled diagrams wherever necessary. 3 X 10 = 30 Marks
- FirstRanker.com Regulatory approval process for Investigational New Drug (IND)
- Write in detail about Eudralex directives for human medicines.
- Elaborate in detail about drug regulatory approval process in Japan.
- Enumerate the regulatory requirements for drug and post approval requirements in ASEAN country.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Explain the approval process of IMPD.
- Write a note on Hatch Waxman Act.
- Differentiate between NDA and ANDA.
- Explain in brief content and approval process of IMPD.
- Write a note on post marketing surveillance in Japan.
- Qualified Person (QP) in EU.
- Write a note on regulatory requirements for orphan drugs.
- Regulatory requirements for Registration of drug in China.
- Write about National and mutual recognition procedures in EU.
- Registration Procedures of drug in South Asia.
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