Exam Details
| Subject | clinical research and regulatory affairs | |
| Paper | ||
| Exam / Course | m.pharm | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | January, 2018 | |
| City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. PHARM SEMESTER-II • EXAMINATION WINTER 2017
Subject Code: 2920206 Date: 01-01-2018
Subject Name: CLINICAL RESEARCH AND REGULATORY AFFAIRS
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
Explain IND application filling process.
06
Write about 'Non Clinical Pharmacology' section of NDA.
05
Write short note on ANDA.
05
Q.2
Discuss role and responsibilities of auditor in clinical trial
06
What is ICH-GCP? Explain the principles of ICH-GCP.
05
Describe regulatory requirements of BE/BA studies.
05
Q.3
Enlist the members of institutional ethical committee (IEC). Describe the functions of IEC.
06
Write a short note on "Protocol Amendments"
05
What information should be provided in case report form in any clinical investigation?
05
Q.4
Describe methods of post marketing surveillance.
06
Write a short note on safety monitoring in clinical trials.
05
Write note on informed consent form for clinical trial.
05
Q.5
Describe schedule Y in clinical research.
06
Explain the role and responsibility of sponsor in clinical trial.
05
Write norms regarding export of drug in India.
05
Q. 6
Explain the various stages of drug discovery and development in brief.
06
Discuss the methods of randomization in clinical trials.
05
Write brief note on Investigator Brochure.
05
Q.7
Write note on data management in clinical trial
06
What is bioavailability? Describe single dose bioavailability study.
05
Explain the quality assurance in clinical trials.
05
GUJARAT TECHNOLOGICAL UNIVERSITY
M. PHARM SEMESTER-II • EXAMINATION WINTER 2017
Subject Code: 2920206 Date: 01-01-2018
Subject Name: CLINICAL RESEARCH AND REGULATORY AFFAIRS
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
Explain IND application filling process.
06
Write about 'Non Clinical Pharmacology' section of NDA.
05
Write short note on ANDA.
05
Q.2
Discuss role and responsibilities of auditor in clinical trial
06
What is ICH-GCP? Explain the principles of ICH-GCP.
05
Describe regulatory requirements of BE/BA studies.
05
Q.3
Enlist the members of institutional ethical committee (IEC). Describe the functions of IEC.
06
Write a short note on "Protocol Amendments"
05
What information should be provided in case report form in any clinical investigation?
05
Q.4
Describe methods of post marketing surveillance.
06
Write a short note on safety monitoring in clinical trials.
05
Write note on informed consent form for clinical trial.
05
Q.5
Describe schedule Y in clinical research.
06
Explain the role and responsibility of sponsor in clinical trial.
05
Write norms regarding export of drug in India.
05
Q. 6
Explain the various stages of drug discovery and development in brief.
06
Discuss the methods of randomization in clinical trials.
05
Write brief note on Investigator Brochure.
05
Q.7
Write note on data management in clinical trial
06
What is bioavailability? Describe single dose bioavailability study.
05
Explain the quality assurance in clinical trials.
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