Download RGUHS M.Pharm 1st Year 2020 5123 International Regulatory Aspects Of Fnpcmb Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharm (Master of Pharmacy) 1st Year (First Semester) 2020 5123 International Regulatory Aspects Of Fnpcmb Previous Question Paper

Rajiv Gandhi University of Health Sciences, Karnataka
First Semester M. Pharm Degree Examination - 14-Jan-2020
Time: Three Hours
Max. Marks: 75 Marks
INTERNATIONAL REGULATORY ASPECTS OF FNPCMB
Q.P. CODE: 5123
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
1.
Regulatory approval process for Investigational New Drug (IND).
2.
Write in detail about Eudralex directives for human medicines.
3.
Elaborate in detail about drug regulatory approval process in Japan.
4.
Enumerate the regulatory requirements for drug and post approval requirements in ASEAN
country.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Explain the approval process of IMPD.
6.
Write a note on Hatch Waxman Act.
7.
Differentiate between NDA and ANDA.
8.
Explain in brief content and approval process of IMPD.
9.
Write a note on post marketing surveillance in Japan.
10. Qualified Person (QP) in EU.
11. Write a note on regulatory requirements for orphan drugs.
12. Regulatory requirements for Registration of drug in China.
13. Write about National and mutual recognition procedures in EU.
14. Registration Procedures of drug in South Asia.
* * * * *

---