ABOUT THE DEPARTMENT
The Department of Pharmaceutical Regulatory Affairs was established in the year of 2010. It was started as a fifth Post Graduate course in Pharmacy at our college. This department consists of 1 Professor, 4 Assistant Professors as faculty members . After successful completion of the course, till now 12 batches of students have passed out. Students after completion of M.Pharm (PRA) were placed in various departments of Pharmaceutical Industries such as Regulatory Affairs, Pharmacovigelance, Quality Assurance, Clinical Data Management, SAS programmers, Medical Coders etc., Passed out students from the Department of Pharmaceutical Regulatory Affairs (PRA) were successful in getting the placements in various prestigious companies such as Eli lilly, Glaxo Smithkline, Hetero Drugs, CDSCO, TATA consultancy services (TCS), Infosys, Mylon Labs, etc., and as Faculty in various reputed Pharmacy Colleges.
VISION
To make Department of Pharmaceutical Regulatory Affairs, as a center of excellence in the area of academics, research & to be a preferred place of destination to study Pharmaceutical Regulatory Affairs .
MISSION
– To impart knowledge, analytical thinking, professional ethics and training for students and faculty members in Pharmaceutical Regulatory Affairs.
– To develop, promote and nurture Regulatory activities by way of collaboration and industry-academia interaction pursuing advances in pharmaceutical Regulatory sciences.
– To provide good theoretical and practical skills and inculcate right attitude through a well balanced curriculum and extracurricular activities.
Subjects Handled by the Department
| Sl. No. | Course Code | Course Title | Year & Semester |
| 1 | MRA 101T | Good Regulatory Practices | I/II M.Pharm.,(PRA) I Semester |
| 2 | MRA 102T | Documentation and Regulatory Writing | I/II M.Pharm.,(PRA) I Semester |
| 3 | MRA 103T | Clinical Research Regulations | I/II M.Pharm.,(PRA) I Semester |
| 4 | MRA 104T | Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights | I/II M.Pharm.,(PRA) I Semester |
| 5 | MRA 105P | Regulatory Affairs Practical I | I/II M.Pharm.,(PRA) I Semester |
| 6 | MRA 201T | Regulatory Aspects of Drugs & Cosmetics | I/II M.Pharm.,(PRA) II Semester |
| 7 | MRA 202T | Regulatory Aspects of Herbal & Biologicals | I/II M.Pharm.,(PRA) II Semester |
| 8 | MRA 203T | Regulatory Aspects of Medical Devices | I/II M.Pharm.,(PRA) II Semester |
| 9 | MRA 204T | Regulatory Aspects of Food & Nutraceuticals | I/II M.Pharm.,(PRA) II Semester |
| 10 | MRA 205P | Regulatory Affairs Practical II | I/II M.Pharm.,(PRA) II Semester |
| 11 | MPH 104T | Regulatory Affairs | I/II M.Pharm., (Pharmaceutics) I semester |
| 12 | 3.4 | Pharmaceutical Jurisprudence | III/VI Pharm.D., |
| 13 | BP 505 T. | Pharmaceutical Jurisprudence | III/IV B.Pharm., 5th Semester |
| 14 | BP 702 T | Industrial Pharmacy II | IV/IV B.Pharm., 7th Semester |
| 15 | BP 805T: | Pharmacovigilance | IV/IV B.Pharm., 8th Semester |
| 16 | BP804 ET: | Pharmaceutical Regulatory Science | IV/IV B.Pharm., 8th Semester |
| 17 | ER20-26T | Pharmaceutical Law & Ethics | II/II D.Pharm., |
The role involves
Ensuring company’s products comply with regulations
Collecting, collating and evaluating scientific data
Preparing submissions for regulatory approval
Advising other departments on regulatory requirements
Providing strategic advice to management for the entire drug development cycle
After successful completion of PG in Pharmaceutical Regulatory Affairs, RA professionals can find employment in the following sectors:
Pharmaceutical, medical devices, cosmetics and biotechnology companies
Government agencies
Clinical and hospital setting
Clinical Research Organizations involved in new drug/medical device/technology development
- As a faculty in Pharmacy institution
Courses Offered
