MASTER OF PHARMACY IN PHARMACEUTICAL REGULATORY AFFAIR
About The Programme:
This course helps to provide a comprehensive education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. It is designed in such a way to provide industrial level education regarding the applicable rules and regulations. Students are encouraged to enhance their knowledge of regulatory and compliance issues and to explore careers in these exciting times. The ever-changing laws and regulations are driving demand for pharmaceutical regulatory affairs professionals, who can help companies effectively bring medical products to market. The course is beneficial as it offers many careers them after passing it successfully. The course also provides the knowledge of filling of information regarding new drug development, manufacture, control, stability studies, packaging, labelling etc. with regulatory agencies in a prescribed format.
After completion of the course, participant is expected to have in-depth knowledge and up-to-date understanding of concept of generic drug and innovator, drug discovery and development, Regulatory strategy, approval process of all regulatory filings in various countries, filing process of IND, NDA and ANDA, IMPD, and Investigator Brochure (IB), DMF, US Hatch Waxman Act and code of federal regulations (CFR), US registration for foreign drugs, Europe IMPD, marketing authorization application (MAA), Centralized procedure, bioequivalence and drug product assessment-in vivo, Manufacturing and Controls (CMC) and their regulatory importance, Submission of global documents (CTD/eCTD), Filing process in India-IND, NDA, Clinical trials (Schedule Y) etc. It offers the combined knowledge of theoretical and practical knowledge in all areas that affects the drug quality. It also provides the working knowledge of various analytical instrumental techniques, method development, documentation, protocol and SOP writing etc.
Intake: 15 seats
Tuition Fee: 12500/- per semester as proposed to the Fee Regulatory Committee.
Approval: The programme is duly recognized by both the Pharmacy Council of India (PCI) and All India Council for Technical Education (AICTE)
Duration of Programme: The duration of this Programme is 2 years after completion of B. Pharm course.
Admission Eligibility: For the purpose of admission, a candidate shall have passed the qualifying examination in the B. Pharm discipline with 55% marks (50% marks for SC/ST/SEBC candidates) and obtained the qualifying marks in GPAT/GSET for pharmacy (Please visit www.jacpcldce.ac.in for more details).
Note: I.S.E.A. = "Internal Assessment Sessional Exams" , E.S.E. = "End Semester Exams", * = "Non University Examination"
Semester 1
Subject code | Subject name | No. of Hours | Credits | Marks (I.A.S.E.) | Duration (I.A.S.E.) | Marks(E.S.E.) | Duration(E.S.E.) | Total Marks |
MRA101T | Good Regulatory Practices | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MRA102T | Documentation and Regulatory Writing | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MRA103T | Clinical Research Regulations | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MRA104T | Regulations and Legislation for Drugs &Cosmetics, Medical Devices, Biologicals &Herbals, and Food & Nutraceuticals In Indiaand Intellectual Property Rights | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MRA105P | Regulatory Affairs Practical I | 12 | 6 | 50 | 6 hr | 100 | 6 hr | 150 |
MRA106P | Seminar/Assignment | 8 | 4 | 100 | | | | 100 |
| Total | 36 | 26 | | | | | |
Semester 2
Subject code | Subject name | No. of Hours | Credits | Marks (I.A.S.E.) | Duration(I.A.S.E.) | Marks(E.S.E.) | Duration(E.S.E.) | Total Marks |
MRA201T | Regulatory Aspects of Drugs & Cosmetics | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MRA202T | Regulatory Aspects of Herbal & Biologicals | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MRA203T | Regulatory Aspects of Medical Devices | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MRA204T | Regulatory Aspects of Food & Nutraceuticals | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MRA205P | Regulatory Affairs Practical II | 12 | 6 | 50 | 6 hr | 100 | 6 hr | 150 |
MRA206P | Seminar/Assignment | 8 | 4 | 100 | | | | 100 |
| Total | 36 | 26 | | | | | |
Semester 3
Subject code | Subject name | No. of Hours | Credits | Marks (I.A.S.E.) | Duration | Marks(E.S.E.) | Duration(E.S.E.) | Total Marks |
MRM301T | Research Methodology and Biostatistics* | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
MJC302P | Journal Club I | 1 | 1 | 25 | | 0 | | 25 |
MDP303P | Discussion/ Presentation (Proposal Presentation) | 2 | 2 | 50 | | | | 50 |
MRW304P | Research Work - Dissertation Phase I | 28 | 14 | 50 | | 300 | | 350 |
| Total | 36 | 26 | | | | | 525 |
Semester 4
Subject code | Subject name | No. of Hours | Credits | Marks (I.A.S.E.) | Duration | Marks(E.S.E.) | Duration(E.S.E.) | Total Marks |
MJC401P | Journal Club II | 1 | 1 | 25 | | | | 25 |
MDP402P | Discussion/ Presentation (Proposal Presentation) | 3 | 3 | 75 | | | | 75 |
MRW404P | Research Work - Dissertation Phase I | 32 | 16 | 0 | | 400 | | 400 |
| Total | | | | | | | 500 |