Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm SEMESTER- III • EXAMINATION WINTER-2017
Subject Code: 1931601 Date: 10-11-2017
Subject Name: Regulatory Affairs-II
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

Write in brief about regulatory requirements of manufacturing and product design in developing country.
06

Describe the parts of a patent and explain significance of Claims therein
05

Briefly describe steps involved in export of drug products from India
05
Q.2

Define contract manufacturing. Explain different licensing procedures and write in brief procedure involved in loan license of Allopathic medicines.
06

Discuss Hatch Waxmann Act its influence on generic product.
05

Write a note on Biotechnology Patenting
05
Q.3

Discuss IP issues related to Contract manufacturing.
06

Write on maintenance of document and records for drug product according to ICH.
05

Define NCE CMC IND Safety Reports IND Annual Report Investigator Brochure
05
Q.4

Write on general consideration and specification requirement for clinical trials.
06

Give a brief account on documentation of manufacturing and recall batches.
05

Write short note on Patent Cooperation Treaty (PCT).
05
Q.5

Give an account on FDA guidelines on clinical trials, review and approval of clinical study.
06

What do you mean BOP analysis? Discuss its impact on international trade
05

Write on influence of socio cultural and political environment on international business.
05
Q. 6

What is clinical research protocol? Discuss objectives and Protocol design.
06

Give an overview on formatting assembling and submitting New Drug Application
05

What is patent drafting? What are the basic strategies require in effective patent drafting.
05
Q.7

Discuss in detail amendments of Drug and Cosmetic act.
06

Explain different types of economies that influence international trading.
05

Write objectives and functions of International Monetary Funding agency.
05