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.
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