School of Pharmacy
PG Diploma in Regulatory Affairs (PGDRA)
Program Overview
Regulatory Affairs is a profession which has developed to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, biopharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole
The course is intended to impart a thorough knowledge of regulations of various national, regional and global regulatory agencies applicable to various stages of development and commercialization of health care products. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies. Regulatory Affairs is an excellent career choice for graduate students from a scientific background who enjoy communication and teamwork, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world.
Employment Opportunities and Placements
The job opportunities are excellent in pharmaceuticals manufacturing, sales, export operations and also in biotech, veterinary, cosmetic, food and medical devices, Contract Research Organizations (CRO), etc. These professionals will find employment as Regulatory Affairs, Quality Assurance, Documentation Officers, Medical Information Associates, Regulatory Affairs Consultants for Pharmaceutical / Biotechnology Industry, Regulatory Food Safety Scientist, Pharmacovigilance Manager, Drug Safety Specialist etc.
Program Structure
Duration: 11 months (Two Semesters)
Fee Structure: Rs 75,000/- per year
| Code | Course | Credit Hours | Credit Points | Hrs./week | Marks |
| Semester I | |||||
| RAP101T | Global Regulatory Affairs (GRA) 45H | 3 | 3 | 3 | 100 |
| RAP102T | Regulatory Requirements Compilation and Submissions (RCS) 45H | 3 | 3 | 3 | 100 |
| RAP103T | Discovery Development and Technology (DDT) 45H | 3 | 3 | 3 | 100 |
| RAP104T | Regulatory Aspects of Drugs and Cosmetics (RDC) 45H | 3 | 3 | 3 | 100 |
| RAP105P | Regulatory Affairs Practical I (RAP I) 180H | 12 | 6 | 12 | 150 |
| RAP106S | Seminar/Assignment/Open Book Test | 6 | 6 | 6 | 50 |
| Total | 30 | 24 | 30 | 600 | |
| Semester II | |||||
| RAP201T | Clinical Research Regulations (CRR) | 3 | 3 | 3 | 100 |
| RAP202T | Medical Devices and IVD Regulations (MDR) 45H | 3 | 3 | 3 | 100 |
| RAP203T | Regulatory Aspects of Herbal and Biologicals (RBH) 45H | 3 | 3 | 3 | 100 |
| RAP204T | Regulatory Aspects of Food and Neutraceuticals (RFN) 45H | 3 | 3 | 3 | 100 |
| RAP205P | Regulatory Affairs Practical II (RAP II) 180H | 12 | 6 | 12 | 150 |
| RAP206S | Seminar/Assignment/Open Book Test | 6 | 6 | 6 | 50 |
| Total | 30 | 24 | 30 | 600 | |
Eligibility
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The candidate should be an Indian National
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Passed Bachelor’s Degree in Pharmacy/Life Sciences from any UGC approved university, with at least 50% marks (at least 45% marks in case of backward class category and persons with disability belonging to Maharashtra State only).