The Advanced Diploma in Drug Regulatory Affairs (ADDRA) course is designed to provide specialised knowledge in the regulatory frameworks governing the pharmaceutical and healthcare industries. The drug regulatory program covers essential topics such as drug approval processes, regulatory compliance, clinical trials, quality control, and global regulatory standards. Students will gain an understanding of the laws and regulations that impact drug development, manufacturing, and marketing, while also learning about the ethical, legal, and safety considerations in the pharmaceutical sector.
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An Introduction to Pharmaceutical Drug Regulatory Affairs |
General Pharmaceutical Laws and Guidelines |
Drug Regulatory Affairs in India |
Information and Quality Management |
Chemical, Pharmaceutical and Biological aspects of Regulatory Documentation |
Clinical Trials and Health Care Policies |
International Licensing |
Regulatory Considerations in Controlled Drug Delivery and Future Aspects of Biopharmaceuticals |
Semester I | Semester II | ||
---|---|---|---|
Registration/Application Fee (One Time) | ₹ 500/- | - | |
Program Fee | ₹ 10,000/- | ₹ 10,000/- | |
Examination Fee | ₹ 2,000/- | ₹ 2,000/- | |
Total Semester Fee | ₹ 12,500/- | ₹ 12,000/- | |
Total Fees | ₹ 24,500/- |
Enhance your expertise in drug regulatory affairs with our advanced diploma program. Watch our video to discover the program's features and how it can advance your career in this critical field.
Upon completion of the Advanced Diploma in Drug Regulatory Affairs program, you will receive the following degree certificate. :