Master of Pharmacy (M.Pharm.) in Drug Regulatory Affairs Course Syllabus

  • course years 2 Years
  • type of course Post Graduate
  • course stream Pharmacy
  • course type Full Time
Written By universitykart team | Last Updated date Jan, 30, 2023

M.Pharm. in Drug Regulatory Affairs Syllabus: Explore topics like drug laws, clinical trials, quality control, and pharmacovigilance.

Syllabus for Master of Pharmacy (M.Pharm.) in Drug Regulatory Affairs course

The Master of Pharmacy (M.Pharm.) in Drug Regulatory Affairs is a specialized program designed to equip students with a comprehensive understanding of the complex and dynamic field of drug regulation. The course syllabus typically covers a wide range of subjects including pharmaceutical laws and regulations, drug approval processes, quality control, pharmacovigilance, and global harmonization efforts. Students delve into the intricacies of pharmaceutical documentation, regulatory submissions, and compliance with international standards. They also study the ethical and legal aspects of drug development, marketing, and post-marketing surveillance. The program often includes practical training in regulatory affairs, providing hands-on experience in preparing regulatory dossiers and interacting with regulatory authorities. By the end of the program, graduates are well-prepared to pursue careers in pharmaceutical companies, regulatory agencies, or consulting firms, where they play a vital role in ensuring the safety, efficacy, and quality of pharmaceutical products, and navigating the ever-evolving landscape of drug regulations.

1st Year OR 1st & 2nd Semester Syllabus of Master of Pharmacy (M.Pharm.) Drug Regulatory Affairs

S.noSubjects
1Good Regulatory Practices
2Documentation and Regulatory Writing
3Clinical Research Regulations
4Regulatory Aspects of Drugs & Cosmetics
5Regulatory Aspects of Herbal & Biologicals
6Regulatory Aspects of Medical Devices
7Regulatory Aspects of Food & Nutraceuticals                                                                                               
8Seminar

2nd Year OR 3rd & 4th Semester Syllabus of Master of Pharmacy (M.Pharm.) Drug Regulatory Affairs

S.NoSubjects
1Research Methodology and Biostatistics                                                                                                     
2Discussion / Presentation
3Research Work

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