|Eligibility||:||B. Pharm (min 60%) from PCI recognized Institute.|
|1st Year Non Sponsored Semester Fee (Rs. in Lacs)||:||0.525|
|1st Year Sponsored Semester Fee (Rs. in Lacs)||:||0.79|
Drug Regulatory Affairs is a major component of pharmaceutical Industry that successfully drives the Research and Development efforts of the company to the market. Increasing global competitiveness among pharmaceutical companies, the key to success lies in obtaining timely marketing approval from the Regulatory agencies of the region where the drug is to be sold. USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada are major government agencies involved in regulating drugs within their market.
Drug Regulatory Affairs is a four semester regular course offering aims to provide a comprehensive education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry including Pharmaceutical Regulatory Affairs, National and International Drug Approvals & Bio-ethics, Modern Analytical Techniques, Research Methodology & Pharmacological Screening, International Regulatory Systems, Clinical Trials & Healthcare Policies, National Regulatory Affairs, Emerging Concept in Regulatory Affairs, Quality Assurance GLP, GMP & Validation, Drug Regulatory Affairs, Intellectual Property Rights & Bioethics, Pharmaceutical Biostatistics & Computer Applications; Laboratory and Research includes: International Regulatory Systems Lab, Clinical Trials & Healthcare Policies Lab, National Regulatory Affairs Lab, Emerging Concept in regulatory Affairs Lab, Pharmaceutical Regulatory Affairs Lab, National & International Drug Approvals & Bio-ethics Lab; In addition to this special emphasis is for Behavioral Science, Communication Skills, Foreign Language (French, German, Spanish, Japanese, and Chinese). Students are motivated and advised to find interest in respective area of research from start of semester. During course of time students are suggested to give presentations on area indentified and work plan. One year is fully dedicated to research work and possible outcome will be patent, publications, thesis or dissertation etc.