The M.Pharm in Pharmaceutical Regulatory Affairs is a first time course offering in India introduced by JSS University. It aims to provide a comprehensive education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. 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 importance of Pharmaceutical Regulatory Affairs
Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and 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, namely, USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada. Regulatory affairs is becoming increasingly influential in the overall drug development process and is increasingly populated by highly trained scientists and medical professionals. 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.
"Drug Development is long, risky, expensive, and those characteristics mean regulatory affairs personnel have their work cut out for them"
Introduction to Pharmaceutical Regulatory Affairs (PRA)
- PRA is a comparatively new and specialised 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, Analysing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world
- PRA professionals are the link between pharmaceutical industries and worldwide regulatory agencies and play a key role in drug development and its approval
- PRA professionals are the primary interpreters of the laws and regulations for other members
Asia has emerged as a strong region for the growth of 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 introduction of product patent in 2005 was a driver for 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. There is also a large presence of national and multi-national companies who are either running or starting research facilities in India.
The demand for quality human resources far outstrips the supply for graduates trained in PRA. The lack of trained professionals, knowledgeable in federal rules and other regulatory aspects makes it a viable career stream to choose.
Figures from www.companiesandmarkets.com report show that the market for clinical trials in India is expected to grow to a billion dollars in the next decade, helped by the fact that the cost of conducting research in the country is sometimes less than half of that in more developed nations.
Pharmaceutical Regulatory Affairs in India
- India is growing very rapidly in the pharmaceutical sector; need of PRA professionals to cater to the current needs of industries globally 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 to India as their preferred destination for drug development, research activities and contract research organisations
- Regulatory affairs is a dynamic, rewarding field that embraces both scientific and legal aspects of drug development; plays a lead and pivotal role in drug development and research activities
- There is a need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare students with the latest developments in the industry
- PRA offers a stable career with a high growth potential
PRA professionals can be employed 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
Why study M.Pharm – Pharmaceutical Regulatory Affairs at JSS University?
JSS has the unique distinction of being the first University to introduce M.Pharm in Pharmaceutical Regulatory Affairs in India. A preferred Health Sciences focused University, JSS offers state of the art infrastructure, video conferencing facilities, individual workstations, latest reference materials and a dedicated staff for the course. The course is in liaison with current pharmaceutical industry requirements.
In addition, the University has national and international PRA professionals roped in for delivering value to this course.
- To provide quality inputs in the area of Pharmaceutical Regulatory Affairs
- To develop documentation / research writing expertise in the field of Pharmaceutical Regulatory Affairs
- To make available a pool of competent professionals in the area of Pharmaceutical Regulatory Affairs
Highlights of the course
- JSS is the first University to offer M.Pharm in Pharmaceutical Regulatory Affairs in India
- Curriculum designed and tailored to cater to the current needs of Pharmaceutical Industries
- Regulatory affairs (PRA) professionals to provide inputs through guest lectures, seminars, video conferences, etc.
- Many national and international regulatory professionals identified as guest speakers
- Need based study, which suits the current industry requirements