Master of Pharmacy (M.Pharm) in Pharmaceutical Regulatory Affairs

Overview

• The key task of the department is to train the postgraduate students in Regulatory Submissions, Annual Reports, Registrations and Listings, which will offer first-rate opportunities to students with high quality educational experience. M. Pharm in Regulatory Affairs recently started with the aim to provide a deeper understanding of pharmaceutical product regulatory submission process to USA, Europe, Japan, Australia and Canada etc.   Department’s laboratory facilities include well equipped computer lab with Industry required, necessary softwares. The department endows wide opportunity to students and teaching staff to learn and analyse using software independently during academic curriculum.
• The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. It is responsible for activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards.
• Regulatory affairs officers act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.
• Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements.

Eligibility

• Students who have passed B.Pharm from approved college only are eligible for admission to M.Pharm. They Must have obtained at least 50 % marks in B.Pharm (for researvation and sponsored candidates 45%).
• Candidate should be an Indian National and who possess Bachelors degree or equivalent in Pharmacy from an AICTE approved institutions, with at least 5O% marks (at least 45% marks in case of SC/ST category & Physically Handicapped candidates belonging to Maharashtra State only).

Minimum Education