Exam Details
| Subject | regulatory affairs | |
| Paper | ||
| Exam / Course | m. pharmacy (pharmaceutics) | |
| Department | ||
| Organization | G. Pulla Reddy College Of Pharmacy | |
| Position | ||
| Exam Date | February, 2018 | |
| City, State | telangana, hyderabad |
Question Paper
FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutics) I-Semester (Main) Examination, February 2018
Subject: Regulatory Affairs
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Explain Hatch-Waxmann Act, its benefits in generic approval.
Write a note on Bolar Amendment.
2 Explain NDA regulatory approval process.
3 What are the regulatory requirements for approval of biologics?
4 Write a note on
CTD and eCTD
ICH Quality guidelines
5 Explain the regulatory requirements of TGA
6 Discuss about global submission of ANDA
7 Write a note on
HIPAA
Pharmacovigilance safety monitoring
8 Write a note on
Investigator brochure
Clinical trial protocol
M. Pharmacy (Pharmaceutics) I-Semester (Main) Examination, February 2018
Subject: Regulatory Affairs
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Explain Hatch-Waxmann Act, its benefits in generic approval.
Write a note on Bolar Amendment.
2 Explain NDA regulatory approval process.
3 What are the regulatory requirements for approval of biologics?
4 Write a note on
CTD and eCTD
ICH Quality guidelines
5 Explain the regulatory requirements of TGA
6 Discuss about global submission of ANDA
7 Write a note on
HIPAA
Pharmacovigilance safety monitoring
8 Write a note on
Investigator brochure
Clinical trial protocol
Other Question Papers
Subjects
- advance biopharmaceutics & pharmacokinetics
- computer aided drug delivery system
- cosmetics and cosmeceuticals
- drug delivery system
- modern pharmaceutics
- molecular pharmaceutics
- regulatory affairs