Download OU M.Pharma Pharmaceutics 1st Sem 2018 1292PCI Regulatory Affairs Question Paper

Download OU (Osmania University) M.Pharma-Pharmaceutics (Master of Pharmacy) 1st Sem 2018 1292PCI Regulatory Affairs Previous Question Paper

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Code No. 1292/PCI
M. Pharmacy (Pharmaceutics) I-Semester (PCI) (Supple.) Examination, August 2018
Subject: Regulatory Affairs
Time: 3 Hrs Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 (a) Explain the importance of documentation in pharmaceutical industry and add a note
on master formula record, distribution records. (10)
(b) Write a note on Code Of Federal Regulation. (5)
2 Explain ANDA regulatory approval process. (15)
3 What are the regulatory requirements for approval of an API? (15)
4 Write a note on
(a) CTD and eCTD (9)
(b) ICH Quality guidelines (6)
5 Explain the regulatory requirements of EU (15)
6 Discuss abt regulations for Combination products a nd Medical devices. (15)
7 Write a note on
(a) informed consent process and procedures (6)
(b) Pharmacovigilance safety monitoring (9)
8 Write a note on
(a) Investigator brochure (7)
(b) investigation of medicinal products dossier (8)
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This post was last modified on 19 July 2020