M. Pharm in Pharmaceutical Regulatory Affair (PCI & AICTE Approved)

• Course Type : Post Graduation
• Course Durations : 2 years
• Course Fees : 100800 /-
• No. Of Seats : 15

About Course

The regulations related to the development, sale, and marketing of healthcare products have seen stricter reforms over the last few decades. Regulatory authorities are being set up in an increasing number of nations throughout the globe. Those which are already set up are restructuring their regulations and trying to match with the regulatory authorities of other nations. The regulatory standards related to healthcare products has seen rapid advancement due to changes in product safety, regulatory compliance, technological transformation, enhanced understanding of disease characteristics and customer requirements. Regulatory professionals do not just function in the initial application process, but also work in the licensing and marketing phases – ensuring that all procedures and products meet necessary safety and efficacy requirements.

Regulatory affairs professionals are in high demand and the career opportunities in this area are phenomenal. This program will provide you a thorough understanding of various regulatory agencies such as the US FDA, EMA, CDSCO; investigational and new drug applications; regulatory strategies and various other concepts.Pharmaceutical Quality System, Indian Pharmaceutical Industry, Overview of GMP, Registration requirements of USFDA, ICH Quality guidelines, WHO, US, Australia, Canada, Japan filing procedures, Dossier preparation in CTD and eCTD format, Regulatory Submission to various region and their marketing authorization procedures,Regulatory Submission to regulated and Semi Regulated Markets etc. This course also includes the industry based projects mimicking regulatory affairs issues including the development of protocols and standard documentation requirements for the pharmaceutical industry. Responding to deficiencies, technical discussion on case studies.