REGULATORY AFFAIRS

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Regulatory Affairs (RA) also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices and energy.

The Pharmaceutical, Biotechnology and Medical device research and development industries are most highly regulated industries in the country. As India is growing very rapidly in the pharmaceutical sector, there is a growing need of regulatory affairs professionals to cater the current needs of industries for the global competition.

Regulatory Affairs Officers are the crucial link between their company, its products and worldwide regulatory authorities including MHRA, USFDA, EMEA. They ensure appropriate licensing, marketing and legal compliance of pharmaceutical and medical products. They combine scientific knowledge, legal and business issues and co-ordinate the approval and registration of pharmaceuticals, veterinary medicines, complimentary medicines, chemicals and pesticides.

Our course is designed as per FDA requirements to cater the need of expertise in the field of pharmaceutical regulatory affairs. The students and professionals currently employed in pharmaceutical / chemical industries will gain a thorough understanding of current regulations and their applications to the development and commercialization of drug, biologic and bio-device products.

The trained students can get the openings in the companies that develop and manufacture pharmaceuticals, chemicals, veterinary, herbal, homeopathic prodcts and medical devices as a Regulatory Affairs Officer, Analyist, Information Officer / Manager, Information Scientist, Research Scientist, Technical Author etc. The working professionals will upgrade their knowledge and skills, which will help them climb the ladder of success in their careers.

Details:

Duration: Nine Months (July to March)

Timings: 6.00 p.m. to 8.00 p.m. (Three days in a week)

Eligibility: B. Sc. / B. Pharm.

Fees: Rs. 15,000/-

Commencement : 1^st week of July

Syllabus

Quality Assurance Principles and Practices
SOPs and SCPs and Good Laboratory Practices Basic Principles and Methods
Drug Master Files
Drug Licensing Application, Renewal and Filing Procedures
USFDA Guidelines
European Guidelines and Rules Governing Medicals Product – EMEA
Therapeutic Goods Administration Australia (TGMP)
International Conference on Harmonization - (ICH Guidelines)
Drug Regulatory Affairs
Introduction to Intellectual Property