Pharmaceutical Drug Regulatory Affairs (DRA) 2023 Course

The drug regulatory affairs course is designed to provide professionals in the pharmaceutical industry with a comprehensive understanding of the drug development process and the regulations that govern it. Here are some key points about the course:

1. Introduction to drug regulatory affairs: The course begins with an overview of drug development and the role of regulatory agencies like the FDA and EMA. Students will learn about international guidelines and regulations.

2. Drug registration process: Students will gain a detailed understanding of the drug registration process in the United States, Europe, and other major markets. This includes learning about the stages of drug development and post-approval changes.

3. Regulation of medical devices and combination products: Students will learn about the regulatory requirements for medical devices and combination products, which involve the combination of drugs and devices.

4. Regulatory Terms

5. Clinical trials and marketing regulations: The role of clinical trials in drug development and the regulatory aspects of marketing and advertising drugs are covered. The course also addresses the changing regulatory landscape due to technological advancements.

6. Submission requirements and post-approval changes: Students will learn about the process and requirements for submitting a new drug application (NDA) or investigational new drug application (IND). They will also understand the requirements for post-approval changes and supplements to a drug product.

7. Fast track: The course covers the process and requirements for these special designations that facilitate expedited development and approval of drugs.

8. Documentation: Students will learn about the various forms of documentation, electronic documentation, web gateways, and tools used during regulatory submissions.

9. Online learning and practical application: The course is delivered online, allowing students to learn at their own pace. They will engage in interactive sessions, and apply their knowledge to real-world scenarios.

By completing this course, students will be equipped with a deep understanding of the drug regulatory process and will be prepared to navigate the complex regulations governing the pharmaceutical industry.

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Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!