Advanced Diploma in Drug Regulatory Affairs (ADDRA)
Course Duration
1 year
Course Eligibility
B. Pharma / MBBS / BUMS or a Bachelor Degree in Science from a recognized University
Course Fees
₹ 12,000/- Per Semester
Program Structure:
| 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 |
Advanced Diploma in Drug Regulatory Affairs Career Job Prospects
Job Title |
Job Description |
Drug Safety Associate |
A drug safety specialist is involved in drug safety management such as conducting clinical trials, medical supervision, keeping a check on all the applicable regulations and SOPs (Standard Operating Procedures). Some even work in co-ordination with chief medical directors. |
clinical research coordinator |
Collecting data obtained from research, coding and analyzing it. Managing budgets set aside for research. Communicating with participants regarding study objectives. |
Director of Regulatory Affairs |
Regulatory Affairs Director is a strategic role that will be responsible for developing, coordinating, and implementing regulatory strategies for new biologic and small molecule products as well as marketed products. |
Clinical Research Associate |
Liaising with doctors/consultants or investigators on conducting the trial. Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. |
Fee Structure
| 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/- | ||
Advanced Diploma in Drug Regulatory Affairs course from Jamia Hamdard University:
Upon completion of the Advanced Diploma in Drug Regulatory Affairs program, you will receive the following degree certificate. :
The main objective of this Programme is to provide an interdisciplinary knowledge of pharmacy and law as applicable in the field of pharmaceutical regulation at national and international levels. The course prepares the students to pursue career in pharmaceutical industry, drug licensing and control authorities, and export- import agencies dealing with the pharmaceuticals.