JSS Academy of Higher Education & Research | Dental College & Hospital

Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs (PRA)

New & emerging discipline of Pharmacy profession
Deals with Knowledge and skills in preparing dossiers for products across globe
Brings R&D efforts to the market
Key player in drug development and their approval
Primary interpreters of the laws and regulations
Advisers on the legal and scientific compulsions and requirements
Provide suggestions in New Policy implementation & research

Why PRA is important?

India is growing rapidly in pharmaceutical sector; there is a need of PRA specialists to cater to the current needs of industries as the global competition is increasing. Regulatory affairs specialists are the link between pharmaceutical industries and world-wide regulatory agencies and are required to be well versed with laws, regulations and guidelines as per different regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries in the curriculum of pharmacy to prepare the students with the latest developments to serve the industries.

Preamble

Pharmaceutical Regulatory Affairs (PRA) course is started in the year 2010 in the Department of Pharmaceutics. The PRA is a comparatively new & specialized discipline, which has developed to protect public health, by controlling the safety and efficacy of products which includes pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. PRA department in a pharmaceutical company is a vital unit that drives the R & D efforts of the company to the market successfully. 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.

Why at JSS College of Pharmacy, Mysuru?

Pioneer institute in India to offer M.Pharm in Pharmaceutical Regulatory Affairs.
State of the art infrastructure, video conferencing & webinar facilities, individual workstations, ebooks, journals, dedicated staff.
Course delivery in liaison with current pharmaceutical industry requirements.
National and International PRA specialist and adjunct faculties facilitate in delivering the course.
Assured placement through campus interviews.

Vision

To make JSS College of Pharmacy, Mysuru a preferred destination to study Pharmaceutical Regulatory Affairs

Mission

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 Health care and related industries

To prepare professionals for regulatory affairs positions in the pharmaceutical sector.
To facilitate the students knowledge with proper foundation in advancing them in the regulatory aspects.
To provide fundamental knowledge as per industrial requirement in the field of regulatory affairs.
To keep track of the ever-changing legislation in all the regions.
To update students with thorough and up-to-date knowledge of global laws and regulations, applicable in the various stages of drug development.
To facilitate students to work on live projects in industries
To provide experiential learning environment for preparing, compiling and submitting required documents as per industry and regulatory authority
requirements for the registration of healthcare products.

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

Regulatory Affairs @ JSSCPM, Mysuru, A Glance

M.Pharm – Regulatory Affairs started in 2010
Brainchild of our Hon. Pro-Chancellor Dr. B. Suresh
State-of-the-art Lab inaugurated in 2012
JSS AHER - First to introduce M.Pharm –RA program in India
120 students graduated
151 publications
218 dissertations
216 presentations
55 RA professionals supporting the program

3 book chapters
Global presence – part of USP Consortium
Regulatory Officers pursuing M.Ph & Ph.D
eCTD PharmReady software
Students trained & certified on eCTD publishing
9 eCTD Training programs conducted
Faculty Development Program – For nurturing budding regulatory staff
Numerous awards and scholarships

Exclusive regulatory affairs suite with

Individual work station
Completely Wi-Fi enabled
Video conferencing facility
Smart class room facility

Faculty

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Adjunct Faculty

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Advisor

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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.