Exam Details
| Subject | regulatory affairs | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | December, 2018 | |
| City, State | maharashtra, solapur |
Question Paper
Master of Pharmacy (Semester (New CBCS) Examination, 2018
(Pharmaceutics)
Regulatory affairs
Day and Date Friday, 14-12-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m. .00 .m. to .00 p.m. All questions are.
I. Answer any five questions
Write a note on "Publishing Data in Regulatory Submission".
Explain the deficiencies and limitations of the current regulatory regime.
Write a note on ICH guidelines on quality.
What is USFDA CFR title 21 Describe its salient features.
Describe the role of regulatory advisor in a pharmaceutical company.
Explain the role of documents in developing clinical trials protocols.
II. Answer any three questions (3×10=30)
What is DMF Enlist and explain the types of drug master files.
Describe the process of registration of a new drug in India.
Describe the procedure for reporting and evaluating the adverse drug
reactions.
Outline the contents and format of the dossier to be submitted as per the
competent authorities. Describe the same.
III. Describe in detail the important stages of drug development. 20
(Pharmaceutics)
Regulatory affairs
Day and Date Friday, 14-12-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m. .00 .m. to .00 p.m. All questions are.
I. Answer any five questions
Write a note on "Publishing Data in Regulatory Submission".
Explain the deficiencies and limitations of the current regulatory regime.
Write a note on ICH guidelines on quality.
What is USFDA CFR title 21 Describe its salient features.
Describe the role of regulatory advisor in a pharmaceutical company.
Explain the role of documents in developing clinical trials protocols.
II. Answer any three questions (3×10=30)
What is DMF Enlist and explain the types of drug master files.
Describe the process of registration of a new drug in India.
Describe the procedure for reporting and evaluating the adverse drug
reactions.
Outline the contents and format of the dossier to be submitted as per the
competent authorities. Describe the same.
III. Describe in detail the important stages of drug 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)