Duration 1 Years |
Level Diploma After 10+2 |
Type Diploma |
Eligibility 10+2 (PCB) |
Post Graduate Diploma in Drug Regulatory Affairs is a Diploma level Pharmacy programme. The course helps to provide a comprehensive education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. Students are encouraged to enhance their knowledge of regulatory and compliance issues and to explore careers in these exciting times. The ever-changing laws and regulations are driving demand for pharmaceutical regulatory affairs professionals, who can help companies effectively bring medical products to market. The course is beneficial as it offers many careers them after passing it successfully.
Syllabus of Drug Regulatory Affairs as prescribed by various Universities and Colleges.
Sem. I |
|
Sr. No. |
Subjects of Study |
1 |
Fundamentals of Regulatory Affairs |
2 |
International Regulatory Requirements |
3 |
Pharmaceutical cGMP & Validation |
4 |
Modern Analytical Techniques |
5 |
Pharmaceutical Regulatory Affairs Lab |
6 |
Modern Analytical Techniques Lab |
7 |
Seminar/Journal Club |
8 |
Project-I |
Sem. II |
|
1 |
Clinical Trial Regulations |
2 |
Preclinical Studies and Toxicity & Toxic kinetics |
3 |
Intellectual Property Rights& Documentation |
4 |
Clinical Trial Regulations Lab |
5 |
Seminar/Journal Club |
6 |
Industrial Training |
7 |
Project-II |
Post Graduate Diploma in Drug Regulatory Affairs College
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