Intake
15
Level of Study
Post Graduate Degree
Mode of Program
Credit Based Semester System (CBSS)
Duration
4 Semesters
Ph. Regulatory Affairs Overview
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.
OBJECTIVES
- To prepare professionals for pharmaceutical regulatory affairs positions in the Industry , Academia & Research.
- To facilitate the students in advancing them in the aspects of Pharmaceutical regulatory affairs knowledge.
- To provide knowledge in the field of regulatory affairs, as per academic, research & pharmaceutical industrial requirement.
- To keep track of the ever-changing legislation in all the regions.
- To update students with thorough knowledge of global laws and regulations, applicable in the various stages of clinical trials, drug development, market authorization approvals across the globe.
- To facilitate students to work on live projects in pharmaceutical regulatory affairs departments at industries
- To provide learning environment for preparing, compiling and submitting required documents as per industry and regulatory authority Requirements for the registration of healthcare products.
| 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 |
Pass in the following examinations
B.Pharm Degree examinations in an Indian University established by law in India from an institution approved by PCI and has scored not less than 55% of maximum marks (aggregate of 4 years B.Pharm).
Every student, selected for admission to post graduate pharmacy program in any PCI approved institution should have obtained registration with the State Pharmacy Council or should obtain the same within one month from the date of his/her admission, failing which the admission of the candidate shall be cancelled.
Selection Criteria Through Merit and written test/ personal interview.
Every student, selected for admission to post graduate pharmacy program in any PCI approved institution should have obtained registration with the State Pharmacy Council or should obtain the same within one month from the date of his/her admission, failing which the admission of the candidate shall be cancelled.
Selection Criteria Through Merit and written test/ personal interview.
Indian Students : INR Rs. 75,000/- ( I Year) and Rs 75,000/- (II Year)
NRI Candidates : USD 10,820/-
NRI Candidates : USD 10,820/-
A graduate in science with a desire to make a difference will find the world of Regulatory Affairs (RA) very rewarding. Regulatory Affairs was introduced by government authorities to monitor and regulate the development, manufacture, testing and marketing of drugs, medical devices, food products, cosmetics and veterinary products. Globalization and the demand for safe medicines and food have spurred the demand for regulatory affairs professionals.
The main function of the regulatory affairs department is to ensure the safety and efficacy of all manufactured medicines, food, devices and cosmetics. Though the role description sounds simple, its execution is more complex. A regulatory affairs professional acts as a link between its employer, its product and the regulatory bodies.
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
- 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
S.No. |
DATE |
EVENTS |
1 |
29/10/2021 |
CURRENT USFDA REGULATIONS FOR PHARMACEUTICALS AND CAREER OPPORTUNITY |
2 |
21/10/2021 |
|
3 |
12/07/2022 |
|
4 |
19/10/2022 |
|
5 |
02/09/2022. |
|
6 |
02/09/2022. |
CAREER GUIDANCE FOR PHARMACY STUDENTS BY DR KMN MURALI KRISHNA |
7 |
25/08/2022 |
|
8 |
23/07/2022 |
ROLE OF YOUTH, TEACHERS AND INTELLECTUALS IN NATION BUILDING |
9 |
22/06/2022 |
|
10 |
10/11/2022 |
PERSONALITY DEVELOPMENT PROGRAMME ON BEHALF OF RASTRA SEVIKA SAMITHI |
11 |
31/01/2023 |
|
12 |
06/03/2023 |
CELEBRATION OF BIRTH ANNIVERSARY OF PROF. MAHADEVA LAL SCHROFF |
13 |
29/03/2023 |
|
14 |
09/06/2023 |
ONLINE WORKSHOP ON INTELLECTUAL PROPERTY RIGHTS AND PATENTS AND DESIGN FILING |
15 |
21/08/2023 |
SIGNIFICANCE OF CLINICAL WRITING IN REGULATORY APPROVAL PROCESS |
16 |
25/09/2023 |
PHARMACIST DAY CELEBRATIONS; THEME ‘PHARMACISTS STRENGTHENING HEALTH SYSTEMS” |
17 |
10/10/2023 |
GOOD MANUFACTURING PRACTICES TO CULTURE OF QUALITY MOVING TO THE DESIRED STATE |
18 |
10/11/2023 |