M Pharm Drug Regulatory Affairs (M Pharm Drug Regulatory Affairs)
The course emphasizes on the technical and practical aspects of regulatory and quality compliance in the pharmaceutical industry. It is the centre of research and development (R and D). The candidates are provided a strong foundation in national and international drug approvals and bioethics, international regulatory systems, clinical trials and healthcare policies, quality assurance Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP) and validation, intellectual property rights and the development and commercialization of drugs, biologics and medical devices. It is an interdisciplinary subject involving the application of chemistry, biology and technology. Topics included in the course are cosmetic technology, herbal medicines, pharmacological screening, clinical trials, medical and scientific writing and nutraceuticals. Candidates will have diverse knowledge about the preparation of medicines, diet required for different medications, laboratory testing and research of novel medications and methods of analysis of different drugs. Special emphasis is provided regarding major government agencies like US Food and Drug Administration (USFDA-US), European Directorate for the Quality of Medicines (EDQM-Europe), Therapeutic Goods Administration (TGA-Australia), Medicines and Healthcare products Regulatory Agency (MHRA-UK) and Therapeutic Products Directorate (TPD-Canada). Skills like analytical reasoning, presentation, computers, decision-making, problem-solving and entrepreneurship are enhanced through dissertations, projects, presentations, internships, publications and viva voce included in this course.