Exam Details
| Subject | regulatory affairs | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | May, 2018 | |
| City, State | maharashtra, solapur |
Question Paper
Master of Pharmacy (Semester (New CBCS)
Examination, 2018
(Pharmaceutics)
regulatory affairs
Day and Date Saturday, 12-5-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions.
Write a note on QSEM guidelines.
Describe the modules used for CTD for marketing authorization.
Explain the importance of documentation in manufacturing.
What are the differences in regulatory environment of regulated countries and rest of the world
Explain basic ethical principles and ethical issues in clinical trials.
What are orphan drugs Explain the regulations governing orphan drugs.
II. Answer any three questions. (3×10=30)
Explain the important routine terminologies used in clinical trials. Add a note on types of clinical research.
Describe the process of approval of new drug in India.
Explain in detail Phase I and Phase II study Indian regulatory authority.
Give organization structure, activities and responsibilities of drug regulatory agency of India.
III. Describe in detail various stages of drug discovery to development. 20
Examination, 2018
(Pharmaceutics)
regulatory affairs
Day and Date Saturday, 12-5-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions.
Write a note on QSEM guidelines.
Describe the modules used for CTD for marketing authorization.
Explain the importance of documentation in manufacturing.
What are the differences in regulatory environment of regulated countries and rest of the world
Explain basic ethical principles and ethical issues in clinical trials.
What are orphan drugs Explain the regulations governing orphan drugs.
II. Answer any three questions. (3×10=30)
Explain the important routine terminologies used in clinical trials. Add a note on types of clinical research.
Describe the process of approval of new drug in India.
Explain in detail Phase I and Phase II study Indian regulatory authority.
Give organization structure, activities and responsibilities of drug regulatory agency of India.
III. Describe in detail various stages of drug discovery to development. 20
Other Question Papers
Subjects
- advanced biopharmaceutics and pharmacokinetics
- advanced pharmaceutical analysis (old)
- advanced pharmaceutical chemistry – i (old)
- advanced pharmaceutical chemistry – ii
- advanced pharmaceutical chemistry – iii (old) (cgpa/cbcs)
- advanced pharmaceutics – ii
- advanced pharmaceutics – iii (old)
- advances in drug delivery (old)
- audits and regulatory compliance
- computer aided drug delivery system
- cosmeticology (elective)
- cosmetics and cosmeceutica
- cosmetics and cosmeceuticals
- drug delivery system
- drug design (elective) (old)
- elective : quality control (old)
- hazards and safety management
- modern pharmaceutical analytical technique
- modern pharmaceutical analytical techniques
- modern pharmaceutics
- molecular pharmaceutics (nano tech and targeted dds)
- pharmaceutical manufacturing technology
- pharmaceutical validation
- pharmaceutics (biopharmaceutics and pharmacokinetics(old) (elective)
- product development (elective)(old)
- product development and technology transfer
- quality assurance
- quality assurance techniques – i
- quality assurance techniques – ii (old)
- quality assurance techniques – iii
- quality control (old)
- quality control and quality assurance
- quality management system
- regulatory affairs
- sterile product formulation and technology
- sterile product formulation and technology (old) (elective)
- therapeutic drug monitoring (old) (elective)