Download PTU M.Pharma 2020 Dec 1st Sem 74660 Regulatory Affairs Question Paper

Download PTU I. K. Gujral Punjab Technical University (IKGPTU) M.Pharma (Master of Pharmacy) 2020 December 1st Sem 74660 Regulatory Affairs Previous Question Paper

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 o ut of S IX qu estio ns.
2 .
Eac h q uestion carry FIFT EEN marks.
1.
a) What are generic products? When can generics be marketed? Outline the process for
obtaining approval for marketing generics.
b) What is NDA? Outline the NDA approval process.
2.
a) How are bioequivalence studies conducted? Mention the ICH requirements for products
to be declared bioequivalent.
b) Clarify the role of CROs in bioequivalence testing.
3.
a) What is eCTD? What are the advantages of filing eCTD?
b) Briefly explain the non-clinical investigations carried out for supporting approval
process.
4.
a) What is meant by "informed consent"? What is the role of informed consent in drug
approval?
b) Explain IMPDI dossier.
5.
a) Write briefly about the ICH regulations pertaining to Safety.
b) What is meant by pharmacovigilance? Explain the ICH requirements and outcomes of
pharmacovigilance.
6.
Write short notes on :
a) HIPAA
b) SUPAC guidelines
c) Regulations for novel therapies
NOTE : Disclosure of Identity by writing Mobile No. or Marking of passing request on any
paper of Answer Sheet will lead to UMC against the Student.
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