REGULATORY AFFAIRS

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

These industries are most highly regulated in the country. As India is growing very rapidly in all these sectors, 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 world wide regulatory authorities including Indian FDA, USFDA, EMEA. They ensure appropriate licensing, marketing and legal compliance of pharmaceuitcal and medical products. They combine scientific knowledge, legal and business issues and co-ordinate the approval and registration of pharmaceuticals, veterinary medicines, complimentary medicines, active pharmaceutical ingradients. etc.

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 commercialisation of drugs, pharmaceuticals and medical device products.

The trained students can get the openings in the companies that develop and manufacture pharmaceuticals, active pharmaceutical ingradients, and medical devices as a Regulatory Affairs Officers, Analyst, 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: One Year

Timings: 6.30 p.m. to 8.30 p.m. (2 days in a week)

Eligibility: B. Sc. / B. Pharm.

Commencement : July / August

Syllabus

Quality Assurance Principles and Practices
SOPs 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

ADDRESS:

VPM's ADVANCED STUDY CENTRE
C/o. B. N. BANDODKAR COLLEGE OF SCIENCE,
THANE COLLEGE CAMPUS, NR. CIDCO BUS STOP,
THANE (W). 400 602. MAHARASHTRA. INDIA.

Tel: (91-22) 25339871
Visit us: www. vpmthane.org E-mail : vpmt@vsnl.net