Duration 3 to 6 Months |
Level Post Graduation |
Type Diploma |
Eligibility Graduation |
Advance Diploma in Clinical Research and Pharma Regulatory Affairs is a postgraduate Medicine course. Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. This novel program provides necessary training for graduate students to develop diverse careers as Clinical Research Associates (CRA), Medical Writers, Clinical Data Coordinators, Drug Development Associates, Business Development Managers, Clinical Project Manager, Clinical Research Manager, Regulatory Affairs Manager and Biostatisticians in Contract Research Organizations (CROs), pharmaceutical companies, government agencies or academia. The course is career orienting in nature that provides many jobs after its successful completion. The duration of the course is three months on a minimum basis and six months on a maximum basis.
Syllabus of Clinical Research and Regulatory Affairs as prescribed by various Universities and Colleges.
Sem. I |
|
Sr. No. |
Subjects of Study |
1 |
Introduction to Clinical Research |
2 |
Guidelines, Regulation & Ethics in Clinical Research |
3 |
Clinical Trial Management & Quality Management |
4 |
Pharma Regulatory Affairs |
|
Specialization |
1 |
Clinical Data Management(link) |
2 |
Pharmacoviglance (link) |
3 |
Medical Writing(link) |
Advance Diploma in Clinical Research and Pharma Regulatory Affairs Colleges
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