Exam Details
Subject | drug regulation and regulatory authority | |
Paper | ||
Exam / Course | m.pharm | |
Department | ||
Organization | Gujarat Technological University | |
Position | ||
Exam Date | November, 2017 | |
City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. PHARM SEMESTER- III EXAMINATION WINTER 2017
Subject Code: 1931501 Date: 10-11-2017
Subject Name: Drug Regulation and Regulatory Authority
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
Explain in detail different provisions of Pharmacy Act 1948.
06
Explain Labeling requirements for Sch Sch X and Sch C drugs.
05
Explain Recent Amendments in regulation of Clinical Trial as per D C Act.
05
Q.2
Write a short note on recent amendments in drug Price control Order 1955.
06
Write a short note on Drug Master file.
05
Write a short note on NPPA.
05
Q.3
Write a short note on IP Review Process.
06
Write a short note on Haemovigilance programme as per US-FDA.
05
Give detail note on Guidelines for formation of Monograph
05
Q.4
Write in detail Pharmacovigilance Programme in India.
06
Write a note on e-CTD.
05
Write in detail about Toxicological studies.
05
Q.5
Write a detail note on E7 Guidelines
06
Write a detail note on E8 Guidelines.
05
Write a detail note on WHO Certification Scheme.
05
Q. 6
Write a note on procedure required for New Drug Application as per US.
06
Write note on Good Clinical Practice as per US.
Give a note on document required for new drug application as per EUDRA guidelines.
05
05
Q.7
What are the different regulatory considerations for evaluation of Clinical Parameters?
Give a note on medical device application procedure as per US.
Give a note on Documents required for clinical trial application Schedule Y.
06
05
05
GUJARAT TECHNOLOGICAL UNIVERSITY
M. PHARM SEMESTER- III EXAMINATION WINTER 2017
Subject Code: 1931501 Date: 10-11-2017
Subject Name: Drug Regulation and Regulatory Authority
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
Explain in detail different provisions of Pharmacy Act 1948.
06
Explain Labeling requirements for Sch Sch X and Sch C drugs.
05
Explain Recent Amendments in regulation of Clinical Trial as per D C Act.
05
Q.2
Write a short note on recent amendments in drug Price control Order 1955.
06
Write a short note on Drug Master file.
05
Write a short note on NPPA.
05
Q.3
Write a short note on IP Review Process.
06
Write a short note on Haemovigilance programme as per US-FDA.
05
Give detail note on Guidelines for formation of Monograph
05
Q.4
Write in detail Pharmacovigilance Programme in India.
06
Write a note on e-CTD.
05
Write in detail about Toxicological studies.
05
Q.5
Write a detail note on E7 Guidelines
06
Write a detail note on E8 Guidelines.
05
Write a detail note on WHO Certification Scheme.
05
Q. 6
Write a note on procedure required for New Drug Application as per US.
06
Write note on Good Clinical Practice as per US.
Give a note on document required for new drug application as per EUDRA guidelines.
05
05
Q.7
What are the different regulatory considerations for evaluation of Clinical Parameters?
Give a note on medical device application procedure as per US.
Give a note on Documents required for clinical trial application Schedule Y.
06
05
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