Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MPH104T Date: 07/01/2019
Subject Name: Regulatory Affair
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

What do you understand by drug master file? Describe types of DMFs in detail.
06

Describe the investigator's brochure for IND.
05

Explain in detail CTD Vs eCTD.
05
Q.2

Describe the procedure for new drug approval from CDSCO in India.
06

Give organization structure, activities and responsibilities of TGA.
05

Write a note on International Good Clinical Practices.
05
Q.3

Discuss the salient features of FDA guidelines for clinical trials in India.
06

Discuss in brief about GHTF guidelines for Medical Device.
05

Discuss briefly about ICH safety guidelines S3B.
05
Q.4

What do you understand by trials in special populations? How is documentation done in bioavailability/bioequivalence studies?
06

Prepare Checklist for HIPAA Compliance.
05

Discuss about clinical research Protocols.
05
Q.5

Enlist ICH Q series guidelines and discuss ICH guideline Q3B(R2) Impurities in new drug products.
06

Write a note on Pre-market approval process for Biologics in USA.
05

Discuss regulatory requirements for Investigational Medicinal Product Dossier (IMPD)
05
Q. 6

Describe general consideration, specific requirements and contents of an NDA.
06

Describe about Post marketing surveillance procedure in USA.
05

Describe contents of Investigator brochure used in clinical trial.
05
Q.7

Write a note on Preclinical studies as per CDSCO.
06

Discuss WHO guidelines for the preparation of Master formula record.
05

Describe how Waxman-Hatch Act has simplified and facilitated approval of generic products in US?
05