The Advanced Diploma Program in Drug Regulatory Affairs (ADDRA) delivers a detailed curriculum that encompasses several aspects of drug regulation.
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About Advanced Diploma Program in Drug Regulatory Affairs
Today's rapidly growing, highly regulated pharmaceutical sector depends on adherence to numerous medication standards and laws. Experts in drug regulatory affairs (DRA) can help with this. A comprehensive understanding of the legal and regulatory frameworks controlling the drug development and marketing process is provided by the Advanced Diploma Program in Drug Regulatory Affairs. Through this curriculum, people can work toward a profession protecting the public, facilitating the release of pharmaceutical items onto the market, and making sure they adhere to all legal requirements.
Students who wish to concentrate on prescription approval, paperwork, compliance, and other regulatory aspects of the pharmaceutical industry may select this curriculum. Enrolling in an Advanced Diploma Program in Drug Regulatory Affairs equips students with skills and information that regulatory professionals greatly value as they navigate the complex world of drug rules.
About the Course
The Advanced Diploma Program in Drug Regulatory Affairs (ADDRA) delivers a detailed curriculum that encompasses several aspects of drug regulation. The comprehensive course assists learners in understanding and equipping themselves with global regulatory requirements, post-market surveillance, and submission process regulations.
Key topics include:
To be eligible for the Advanced Diploma Program in Drug Regulatory Affairs (ADDRA), applicants must fall in the following prerequisites:
Advanced Diploma Program in Dietetics and Therapeutic Nutrition | Semester 1 | Semester 2 |
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/- |
The Advanced Diploma Program in Drug Regulatory Affairs (ADDRA) holds approvals from several accredited institutions:
Graduates of the Advanced Diploma Program in Drug Regulatory Affairs (ADDRA) can explore several career opportunities, a few of which are mentioned below:
By collaborating with pharmaceutical companies, contract research organizations (CROs), regulatory agencies, and healthcare organizations, graduates may guarantee that drugs adhere to international rules and are safely introduced into the market.
A1. An expert in medication regulatory affairs ensures that pharmaceutical companies comply with all applicable laws, including those concerning product research, marketing, and post-approval surveillance. Throughout the life of the product, they manage submissions for pharmaceutical approvals to regulatory agencies and uphold compliance.
A2. The duration of the program spans 1 year of duration. However, some universities offer the program with an extended duration which ranges from 6 months to 2 years.
A3. There are several universities in India offering the program. But we have mentioned a few universities offering the program with quality education of global standards
1. Global Institute of Regulatory Affairs (GIRA), Pune
2. Al Ameen College of Pharmacy, Bangalore
3. Indira Gandhi Institute of Pharmaceutical Sciences, Odisha
4. Jamia Hamdard University.
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