Program Overview
The total revolution of biological and chemical sciences has resulted into new concepts in pharmaceutical sciences giving rise to importance of regulations for the new products. Regulatory Affairs (RA) is an upcoming profession within the biomedical / health products sector. RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world. In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned.
The pharma regulatory affairs are important for the knowledge of the laws and regulations mandated by the federal government, especially those of the Food and Drug Administration (FDA), as they apply to the development, testing, approval, manufacturing, commercialization and postmarking surveillance of pharmaceutical, biopharmaceutical and medical device products.This program is intended to provide students with a basic understanding of the areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
BII has introduced the course as the education and knowledge would able to benefit the academia as well as the industry and the jobseekers. BII caters as a bridge between the high-potential research with academia and industry which is an utmost need because of cost and time barriers.
Careers in Regulatory Affairs
Pharma is a highly regulated industry the world over and professionals, who can manage regulatory affairs, are in high demand.
Selling drugs is not like selling anything else, when we sell drugs we need to be confident that
- They do what they claim to do
- They have been through a tough testing process to get from the lab to the market
- The side effects are well documented .
This is where regulatory affairs come in.
“Regulatory Affairs Professional is the key link to distributing your drugs to world region.”
The Indian Pharmaceutical industry is one of the fastest growing industry in India, with a CAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally.
With such a high growth rate and rapid globalization there is a substantial need for highly trained professionals ready to perform the work required within this specialized industrial sector who will keep updates with regulatory law, policies and procedures for one or more product lines as well as maintain an understanding of the scientific and technical background of new products.
The increasing graph of the global companies’ setup in India demands the trained and skilled professional on a Handsome Salary, looking back for past few years rise in salary is multiplying.
There is a widening gap of rising demand and too few skilled human resource, this has seen a 50 % zoom on average in salaries for skilled manpower specifically in CRO sector alone. On an average there has been over 30% rises in salaries in Pharmaceutical Sector.
Research & Development activity in the Pharma sector is seeing a rapid growth and this growth is only poised to increase the need for skilled manpower and higher pay scale to retain the skilled.
What you will need to become a RA professional
- A good background knowledge of the pharmaceuticals and medical environment
- A meticulous approach to work
- Academic Qualification in Regulatory Affairs which can be attained by BII’s course.
Course Curriculum :Module-I Introduction to Pharmaceutics
Module-II Pharma Regulation Practices and Procedures
Module-III Pharma Patents, IPR and Regulation
Module-IV Clinical Trials and Regulation
Module-V Pharma Regulatory Regime in USA, EU and India
Module-VI Regulatory Compliance for Pharma and Biotech Products
Eligibility:
Science Graduation. The eligibility for the training program is graduation in any discipline. Medical professionals, pharmacists etc .Any one of the following minimum qualifications is mandatory to be eligible. Sc., / M. Sc., in Life science with minimum 50% in any one of the following subjects: Biotechnology, Microbiology, Genetics, Biochemistry or life sciences. M.B.B.S / B.D.S / B.A.M.S / B.H.M.S /B. Pharmacy/ M. Pharmacy, B.E (BT) / B. Tech (BT) Note: Final Year / Pre final students can also apply for the Course.
BIOINFORMATICS INSTITUTE OF INDIA
C-56A/28, Sector - 62,
Noida - 201 301
(INDIA)
Tel : 0120-4320801/02
Mobile:09818473366,09810535368
E-mail : info@bii.in
