What is Pharmaceutical Regulatory Affairs (PRA)?:
- PRA is a comparatively new & specialized profession, which has developed to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
- PRA profession deals with the knowledge and skills of Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world.
- PRA department in a pharmaceutical company is a vital unit that drives the R & D efforts of the company to the market successfully.
- PRA professionals are the link between pharmaceutical industries and world-wide regulatory agencies, play a key role in drug development and its approval.
- PRA professionals are the primary interpreters of the laws and regulations for other members of the pharmaceutical R&D, manufacturing, and compliance staff.
- PRA professionals are responsible for keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products, advice on the legal and scientific restraints and requirements, and collect, collate and evaluate scientific data.
- PRA professionals are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned.
Need for Pharmaceutical regulatory affairs
In today’s ever-changing laws and regulations and competitive environment, the reduction of the time taken to reach the market is vital to a product’s and hence the company’s success. The proper conduct of its regulatory affairs by a PRA professional is therefore of considerable economic significance for the company.
Thus, JSS University has started M. Pharm in Pharmaceutical Regulatory Affairs for the first time in India.
Why Pharmaceutical regulatory affairs is important?
Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research & Development (R&D) efforts of the company to the market.The regulatory department works with a focus to get products to the market with a commercially viable label, in the least possible time and expense. In view of the increasing global competitiveness among pharmaceutical companies, the key to success lies in obtaining timely marketing approval from the Regulatory agencies of the region where the drug is to be sold. Various government agencies are involved in regulating drugs within their market. Some of them include USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and MHLW-Japan.
Drug Development is long, risky, and expensive, and those characteristics mean regulatory affairs personnel have their work cut out for them.
Years ago, regulatory affairs was often just a place where paperwork was done. There is still a lot of paperwork, although much of it is now in electronic format, but science and strategy now take precedence.
Regulatory affairs is a serious profession limited not only to preparation of dossiers but also covers all the regulation to follow at a manufacturing site as mentioned by respective Ministry of Health. A PRA professional should be updated with changing rules and regulation in the particular region. Dossier preparation is mere a basic step in regulatory affairs, it lifecycle maintenance, query response, its renewal and sharing the registration documents with the plant.
Career Spotlight: Pharmaceutical Regulatory Affairs
Asia has emerged as a strong growth region for the pharmaceutical industry in recent years, in particular India, which is fast becoming a preferred location for clinical trials and research and development activities. The creation of a new product patent system in 2005 was a driver of this growth, which is expected to increase as the domestic market in India further opens up. This growth has also helped facilitate an increasing number of pharma regulatory affairs jobs in India. A number of companies have set up in the most populous city in the country, creating a number of regulatory affairs jobs in Mumbai. Figures from www.companiesandmarkets.com report show that by the year 2012 the market for clinical trials in India is expected to grow to $630 million (£404 million), helped by the fact that the cost of conducting research in the country is sometimes less than half that in more developed nations.
Program outcome
To make available a pool of competent professionals in the area of Pharmaceutical Regulatory Affairs with fundamental knowledge on
- Various Good Regulatory Practices in the Healthcare and related industries.
- Documentation and general principles involved in regulatory writing and submission to agencies.
- Audit, inspections, Quality management system and Product Life Cycle Management.
- Clinical drug development and research regulations in India, EU and US
- Regulations for Drugs, Cosmetics, Medical Devices, Herbals, Biologics, Food and Nutraceuticals in various countries like India, EU, US, Canada, Japan, ASEAN, etc.,
Why Pharmaceutical Regulatory Affairs in India?
After IT boom, it is Pharmatechnology (PT) and Biotechnology (BT) sector which is catching up.
- India is growing very rapidly in pharmaceutical sector; need of PRA professionals to cater the current needs of industries for the global competition is increasing.
- Pharmaceutical Industry is in immense need of professionals capable of handling issues related to regulatory affairs in a comprehensive manner.
- MNCs abroad are looking forward to India as their preferred destination for the drug development, research activities and contract research organizations.
- Regulatory affairs is a dynamic, rewarding field that embraces both scientific and legal aspects of drug development, plays a lead & pivotal role in drug development and research activities.
- A growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries
- PRA is in highest demand and fastest growing profession*
Highlights of the Course
- First university to offer M-Pharmacy in Pharmaceutical Regulatory Affairs in India.
- Regulatory affairs (RA) professionals to provide the inputs as guest lectures, seminars, video conferences etc.,
- Many national and international regulatory professionals identified as guest speakers.
- Need based study, suits the current industry requirements.
- PRA is in high demand and fastest growing profession.
Salient features
- Exclusive regulatory affairs lab (like a corporate office) with 30 computers and completely Wi-Fi enabled
- Guest lectures by national and international experts.
- Seminars, online video conferences, separate library for regulatory department
- Industrial training for a period of 8 months as a part of academics for practical knowledge in Department of Pharmaceutical Regulatory Affairs in leading pharmaceutical industries in the country
Job opportunities
- Demand exceeding the supply, ample opportunities for graduates trained in PRA
- Increased number of national and MNCs starting research facilities in India, demands trained and technical professionals.
- Lack of trained professionals knowledgeable in federal rules and other regulatory aspects
- RA professional can get employment as
- Regulatory Affairs Consultants
- Regulatory Affairs Associates
- Regulatory Affairs Assistants/ specialist
- Regulatory Affairs head/ Director
- Regulatory Administrator
- Regulatory Compliance Manager
- Medical Information Associates
- Drug Inspector/Drug Controller
- Drug Safety Specialist/ Regulatory Food Safety Scientist
- Quality Operations/Quality Control/Quality Assurance
DELIVERY OF THE COURSE
Course content
“Credit Based Semester System (CBSS) of the Pharmacy Council of India, New Delhi”.
Duration of the program
The program of study for M-Pharmacy,shall extend over a period of four semesters(two academic years).
Paper |
Code |
Subject |
FIRST SEMESTER |
I |
MRA101T |
Good Regulatory Practices |
II |
MRA102T |
Documentation and Regulatory Writing |
III |
MRA103T |
Clinical Research Regulations |
IV |
MRA104T |
Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals in India and Intellectual Property Rights |
V |
MRA105P |
Regulatory Affairs Practical I |
SECOND SEMESTER |
VI |
MRA201T |
Regulatory Aspects of Drugs & Cosmetics |
VII |
MRA202T |
Regulatory Aspects of Herbals & Biologicals |
VIII |
MRA203T |
Regulatory Aspects of Medical Devices |
IX |
MRA204T |
Regulatory Aspects of Food & Nutraceuticals |
X |
MRA205P |
Regulatory Affairs Practical II |
Seminar and Assignment in 1st and 2nd Semester |
THIRD SEMESTER |
XI |
MRM301T |
Research Methodology and Biostatistics |
Journal Club, Research Proposal and Research work |
FOURTH SEMESTER |
Journal Club, Research work and Submission. |
Project Areas
- Drug registration process in specific countries
- Generic drug approval process in different countries.
- Lead challenges faced during drug registration
- Data Integrity, Six Sigma Concept and Quality by Design.
- Research on updated regulations and practices in Clinical Trials, Drugs, Cosmetics, Herbals, Biologicals, Biosimilars, Medical Devices, Food and Nutraceuticals.
- FDC Drugs, BA/BE studies.
Collective Human Resource
Project Areas
- Drug registration process in specific countries
- Generic drug approval process in different countries.
- Lead challenges faced during drug registration
- Data Integrity, Six Sigma Concept and Quality by Design.
- Research on updated regulations and practices in Clinical Trials, Drugs, Cosmetics, Herbals, Biologicals, Biosimilars, Medical Devices, Food and Nutraceuticals.
- FDC Drugs, BA/BE studies.
Collective Human Resource
A pool of dedicated and dynamic staff from JSS College of Pharmacy, Mysore and Ooty has been identified and pooled for effective and efficient delivery of the course.
Sl No |
Faculty |
Qualification |
Designation |
Experience |
1 |
Dr. K. Gowthamrajan |
M.Pharm, Ph.D. |
Professor |
Years |
2 |
Dr. V Senthil |
M.Pharm, Ph.D. |
Professor |
Years |
3 |
Dr. R Suresh Kumar |
M.Pharm, Ph.D. |
Asst. Professor |
Years |
4 |
Dr. D Nagaswamy Venkatesh |
M.Pharm, Ph.D. |
Asst. Professor |
Years |
5 |
Dr. G N K Ganesh |
M.Pharm, Ph.D. |
Asst. Professor |
Years |
6 |
Dr. N. Jawahar |
M.Pharm, Ph.D. |
Asst. Professor |
Years |
7 |
Mr. Karri V V S Narayana Reddy |
M.Pharm ( Ph.D. ) |
Lecturer |
Years |
8 |
Mr.Arun R |
M.Pharm ( Ph.D. ) |
Lecturer |
Years |
Why at JSS University?
- First university in India to offer M.Pharm in Pharmaceutical Regulatory Affairs
- First university in India to introduce block teaching in the M.Pharm PRA program
- State of the art infrastructure, video conferencing facilities, individual workstations, ebooks, journals, dedicated staff
- Course in liaison with current pharmaceutical industry requirements
- National and International PRA professionals roped in for delivering the course
- Mission “To make the JSS University a preferred destination to study Pharmaceutical Regulatory Affairs”
ADMISSION
Eligibility
A candidate who has passed B. Pharm degree examination from any recognized University and has secured not less than 55% of the maximum marks (aggregate)
Selection Criteria
Through Merit and written test/ personal interview
Intake capacity
Annual intake capacity is 12 seats
Program Duration
Two years from the commencement of academic term.
Course to be conducted at
JSS College of Pharmacy, Ooty
Contact:
JSS College of Pharmacy.
(Constituent College)
JSS Academy of Higher Education and Research
(Established under section 3 of UGC Act)
“Rocklands”, Udhagamandalam-643001
The Nilgiris, Tamil Nadu.
Karnataka, India.
Phone: +91-821-2548400
Fax: +91-821-2548394
Website: www.jssuni.edu.in