Download PTU M-Pharma 2019 May 1st Semester 74660 REGULATORY AFFAIRS Question Paper

Download PTU (Punjab Technical University) M-Pharma (Master of Pharmacy) 1st Semester 74660 REGULATORY AFFAIRS Last 10 Years 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011 and 2010 Previous Question Papers.

1 | M-74660 (S31)-1899

Roll No. Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Pharmaceutics) (2017 & Onwards) (Sem.?1)
REGULATORY AFFAIRS
Subject Code : MPH-104T
M.Code : 74660
Time : 3 Hrs. Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

1. Discuss the following with suitable examples and/or flow charts :
a. ECTD 5
b. Scale-up process approval 5
c. Regulation for combination products 5
2. a. Discuss the NDA regulatory approval process with suitable example. 8
b. Write a note on outsourcing BA-BE studies to CRO. 7
3. Write short notes on the following :
a. Drug product performance 5
b. Master formula record 5
c. Post marketing surveillance 5
4. Give a detailed account on development of clinical trial protocol for an anti- depressant
drug. 15
5. Write short notes on the following :
a. ICH-S guidelines 8
b. Regulatory requirements of MHRA 7
6. Discuss the following with suitable examples :
a. IND 5
b. Dossier (IMPD) 5
c. HIPAA 5

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