Exam Details

Subject regulatory affairs and new drug applications
Paper
Exam / Course m.pharm
Department
Organization Gujarat Technological University
Position
Exam Date November, 2018
City, State gujarat, ahmedabad


Question Paper

Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code:2920204 Date: 19/11/2018
Subject Name: Regulatory Affairs and New Drug Applications
Time:02:30 PM TO 05:30 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

Give brief account on manufacture distribution and sale of drug according to Drug and Cosmetic Act 1940.
06

Describe objectives of The Pharmacy Act 1948.
05

Write note on constitution of pharmacy council of India.
05
Q.2

Describe regulatory aspects of pharmaceutical products in detail.
06

Explain in brief about functions of pharmacy council of India.
05

Short note on quality control of herbal products.
05
Q.3

Write short note on Consumer Protection Act.
06

Describe salient features of Prevention of Food Adulteration Act.
05

Give salient feature of Pollution Control act.
05
Q.4

Explain WHO certification agency.
06

Give full form of NDA, IND, MSDS, TGA, UK-MCA
05

Explain DMF in brief.
05
Q.5

Give purpose and scope of each section of MSDS.
06

Give organization structure, activities and responsibilities of drug regulatory Agency of US.
05

Give brief comparative picture of IP, USP, BP and EP.
05
Q. 6

List out different types of IND. Describe the format content of IND.
06

Describe contents and format of an NDA
05

What is ICH? Write in brief about responsibilities of ICH.
05
Q.7

Write manufacturing control requirement of NDA
06

Describe the investigator's brochure for IND.
05

Define: 1. Drug 2. Cosmetics 3. MSDS 4. Adulterated drug 5. Spurious drug
05



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Subjects

  • advanced medicinal chemistry
  • advanced organic chemistry-i
  • advanced organic chemistry-ii
  • advanced pharmacology ii
  • advanced pharmacology-i
  • advances in drug delivery system
  • advances in pharmacology
  • applied pharmacotherapeutics - ii
  • applied pharmacotherapeutics-i
  • audits and regulatory compliance
  • biological evaluations & clinical research
  • cellular and molecular pharmacology
  • clinical and hospital pharmacy
  • clinical pharmacy practice
  • clinical research and pharmacy practice
  • clinical research and regulatory affairs
  • clinical research regulations
  • cosmetic and cosmeceuticals
  • documentation and regulatory writing
  • drug design and discovery
  • drug regulation and regulatory authority
  • experimental design and patents
  • global regulatory requirements
  • gmp, glp and validation
  • good manufacturing and good laboratory practice
  • good manufacturing practice and process validation
  • good regulatory practices
  • hazards and safety management
  • industrial pharmacy practice
  • modern analytical techniques
  • modern pharmaceutical analysis
  • novel drug delivery system part-i
  • novel drug delivery system-ii
  • pharm. management -ii
  • pharmaceutical analysis ii
  • pharmaceutical and cosmetic analysis
  • pharmaceutical formulation and development
  • pharmaceutical formulation development and biopharmceutics
  • pharmaceutical manufacturing technology
  • pharmaceutical production management & technology
  • pharmaceutical regulatory affairs
  • pharmacological and toxicological screening methods-i
  • pharmacological and toxicological screening methods-ii
  • pharmacometrics and methods of biological evaluation of drugs
  • pharmacotherapeutics
  • principles of biopharmaceutics& pharmacokinetics
  • product development and technology transfer
  • quality control & quality assurance
  • quality control and quality assurance
  • quality management system
  • regulatory affairs - i
  • regulatory affairs and new drug applications
  • regulatory aspects of hebbal and biologicals
  • research methodology
  • validation and product development