Download PTU (Punjab Technical University) M-Pharma (Master of Pharmacy) 2nd Semester 74938 REGULATORY ASPECTS OF HERBAL AND BIOLOGICALS Last 10 Years 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011 and 2010 Previous Question Papers.
Roll No. Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy(Regulatory Affairs) (2017 Batch) (Sem.?2)
REGULATORY ASPECTS OF HERBAL AND BIOLOGICALS
Subject Code : MRA-202T
M.Code : 74938
Time : 3 Hrs. Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.
Q1. Write in the detail about various data requirements for Pre-clinical and clinical studies in
India. (15)
Q2. Write notes on the following :
(a) Biosimilars (6)
(b) Pharmacovigilance (9)
Q3. (a) Elaborate on the process for IND and NDA in USA. (7)
(b) What are the various requirements and procedures for registering and marketing
vaccines in India? (8)
Q4. Discuss in detail various legislator requirements for herbal drugs/CAM in US market. Also
discuss in detail about DSHEA. (15)
Q5. Write notes on following :
(a) Plasma master file (6)
(b) Labeling and packaging requirements for Blood products for European market (5)
(c) Process and requirements for BLA (4)
Q6. Compare the pre-clinical and clinical development considerations for biologicals in USA
and European Union. (15)
NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any
page of Answer Sheet will lead to UMC against the Student.
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This post was last modified on 07 December 2019