M. Pharm - Drug Regulatory Affairs

Eligibility : B. Pharm (min 60%) from PCI recognized Institute.
Duration : 2 Yr(s)
1st Year Non Sponsored Semester Fee (Rs. in Lacs) : 0.525
1st Year Sponsored Semester Fee (Rs. in Lacs) : 0.79
Course Structure  
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Details of the M Pharm (Drug Regulatory affairsent) Programme

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.

Programme Focus:

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.

Scope of the M Pharm (Drug Regulatory affairsent)



Regulatory Affairs Consultants

Regulatory Affairs Associates

Regulatory Affairs Assistants / Specialist

Regulatory Affairs Head / Director

Regulatory Administrator

Regulatory Compliance Manager

Medical Information Associates

Drug Inspector / Drug Controller

Drug Safety Specialist / Regulatory Food Safety Scientist

Quality Operations / Quality Control / Quality Assurance

Academics