Exam Details
| Subject | regulatory affairs - i | |
| Paper | ||
| Exam / Course | m.pharm | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | May, 2017 | |
| City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm SEMESTER-II • EXAMINATION SUMMER-2017
Subject Code: 1921601 Date: 29/05/2017
Subject Name: Regulatory Affairs I
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
Describe provisions for performance of animal experiments as per prevention of cruelty of Animal Act.
06
Discuss Medicinal and toilet preparation act with latest amendment.
05
Discuss about Direct and indirect tax laws.
05
Q.2
Describe briefly the manufacture of alcoholic preparations in Bond under the medicinal and toilet preparations act.
06
What are the aims and objectives of Pharmacy Act 1948? Describe the role of pharmacy council of India in pharmacy education.
05
Compare and contrast laws pertaining to Patent in USA and India.
05
Q.3
Discuss about historical perspective of Pharmaceutical Legislation.
06
Describe briefly about trade mark act.
05
Explain scope, functions and benefits about WTO.
05
Q.4
Discuss role of SEBI as financial instrument regulator.
06
What is copyright? Discuss the various rights availed through copyright act.
05
Discuss the salient features of TRIMS.
05
Q.5
Discuss the procedure for calculation of the wholesaler and retailer price as per DPCO.
06
Discuss non patentable inventions as per Indian patent law.
05
Discuss Schedule U requirements for Product development stage documentation.
05
Q. 6
What is SOP? Explain objectives, format and content of SOP.
06
Discuss the need of government regulation on financial bodies.
05
Describe the procedure for the registration of Trademark.
05
Q.7
Discuss the duties and powers of Drug Inspector as per Drugs and Cosmetic Act 1940.
06
Discuss the development of Indian patent law in brief.
05
Write a brief note on TRIPS.
05
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm SEMESTER-II • EXAMINATION SUMMER-2017
Subject Code: 1921601 Date: 29/05/2017
Subject Name: Regulatory Affairs I
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
Describe provisions for performance of animal experiments as per prevention of cruelty of Animal Act.
06
Discuss Medicinal and toilet preparation act with latest amendment.
05
Discuss about Direct and indirect tax laws.
05
Q.2
Describe briefly the manufacture of alcoholic preparations in Bond under the medicinal and toilet preparations act.
06
What are the aims and objectives of Pharmacy Act 1948? Describe the role of pharmacy council of India in pharmacy education.
05
Compare and contrast laws pertaining to Patent in USA and India.
05
Q.3
Discuss about historical perspective of Pharmaceutical Legislation.
06
Describe briefly about trade mark act.
05
Explain scope, functions and benefits about WTO.
05
Q.4
Discuss role of SEBI as financial instrument regulator.
06
What is copyright? Discuss the various rights availed through copyright act.
05
Discuss the salient features of TRIMS.
05
Q.5
Discuss the procedure for calculation of the wholesaler and retailer price as per DPCO.
06
Discuss non patentable inventions as per Indian patent law.
05
Discuss Schedule U requirements for Product development stage documentation.
05
Q. 6
What is SOP? Explain objectives, format and content of SOP.
06
Discuss the need of government regulation on financial bodies.
05
Describe the procedure for the registration of Trademark.
05
Q.7
Discuss the duties and powers of Drug Inspector as per Drugs and Cosmetic Act 1940.
06
Discuss the development of Indian patent law in brief.
05
Write a brief note on TRIPS.
05
Other Question Papers
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