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: 13,125/- 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).
VISION
- To emerge as a globally recognized premier Pharmacy Institute in Teaching, Research, Innovations, Consultancy and Entrepreneurial Training in Pharmaceutical Sciences.
MISSION
- To implement modern pedagogical methods to excel in teaching, learning and research through necessary resources.
- To develop a transparent management system that facilitates staff development and encourages innovation and flexibility.
- Development of multi talent human resources by skill up-gradation of students through specialized courses and training and by facilitating international student and faculty exchange programmes.
- To engage in translational research through interdisciplinary research team and intensive symbiosis with the industries & research institutes for mutual benefits.
- To organize International & National conferences, structured workshops and outreach programmes for the benefit of students, professionals and society.
PROGRAM OUTCOMES
- Independently carry out research /investigation and development work to solve practical problems.
- To write and present/publish a substantial technical report/document.
- To apply the knowledge of regulatory requirements of pharmaceuticals and implementation of it for the preparation of regulatory submission.
PROGRAM SPECIFIC OUTCOMES
- To gain knowledge on various global good regulatory practices.
- To learn basic skills of documentation, regulatory writing and submission to authorities.
- To understand regulations and legislation of various countries with respect to drugs, cosmetics, biologicals, herbals, nutraceuticals and medical devices.
- To prepare regulatory dossier of drugs, cosmetics, biologicals, herbals, nutraceuticals and medical devices with the help of effective tool.
- To impart the fundamental knowledge on the clinical development process, clinical trials and regulations for pharmaceuticals preparations and Medical Devices.
PROGRAM EDUCATIONAL OBJECTIVES
- Demonstrate deep methodological skill and an understanding of contemporary research in their respective area of emphasis, and be able to implement innovative research practices under guidance of their faculty member.
- This program will be able to provide a knowledge to students to become a lifelong learner to absorb new technologies and thus offer leadership role in the society.
- Demonstrate the ability to investigate case studies related to various regulatory topics (e.g. regulatory submissions, product defect, clinical trials and quality assurance strategies etc.).
- To introduce regulation, professionalism, team spirit, communication skills, social and ethical commitment in the students in order to embellish leadership roles facilitating improvement in healthcare sector with a distinct professional identity,
- Demonstrate the factors which influence domestic and international regulatory decisions and develop methods to incorporate regulatory trends and practice about product development, market approvals and marketing.
Note: I.S.E.A. = "Internal Assessment Sessional Exams" , E.S.E. = "End Semester Exams", * = "Non University Examination"
| 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 |
| 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 |
| 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 |
Tokyo
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