Pharmaceutical Management and Regulatory affairs:
The aim of this post graduate programme is to provide participants with good theoretical and practical up to date knowledge of international regulatory affairs related to pharmaceuticals. Pharmaceutical Regulatory Affairs is a department in a pharmaceutical company that initiates the process of compilation of all documents in line with various regulatory requirements. They keep themselves abreast of all changes and ensure that all changes get implemented within the permissible timeframe. They also keep track of the NDAs and ANDAs for which approval has been sought. This department prepares the answers to customers and regulatory authorities on queries that are raised on ANDAs and NDAs already filed.
The other major content in the programme is pharmaceutical management. The student gets an overview of the way a pharmaceutical company is managed in all aspects. The course introduces them to the latest concepts and practices related to functional areas of management. The areas covered are finance management, production planning and inventory control, basics of selling marketing. Besides this, the students get to know other related laws governing the industry The students are offered training in good companies and are well placed in major pharma companies.
There is expected to be a huge demand for qualified RA personnel in clinical research and international regulations
RA ensures that all departments understand the regulations and comply. Substantive exposure to management practices.
Duration of the course: 2 Years
Student intake: 15