2/11/2020

Investigational New Drug (IND) Application

So now you are ready to submit an IND application before you begin a clinical trial. The FDA regulation 21 CFR Part 312 covering the IND can seem lengthy and broad. What do you need to know to get started? An IND is basically asking to be exempt from the current law that regulates marketed products and for permission to study an investigational product in humans. Learn about definitions for the terminology and the responsibilities of the sponsor and investigator under the IND regulation in this interactive, on-demand eLearning course.

What is Next?

Once there is enough data to support the safety and efficacy of the investigational product, you are ready to submit an Application for FDA Approval to Market a New Drug, or NDA. Ensure you understand the documentation required to explain the investigational product’s entire story to support the FDA’s decision making. Get an in-depth understanding of how 21 CFR Parts 312 and 314 support the application process throughout the eLearning course.

With this interactive, on-demand eLearning course, you will:

Learn how to apply critical thinking techniques for effective implementation of 21 CFR Part 312 and 314.
Learn how the regulations affect your role in clinical research.
Discuss challenges and opportunities in implementing the regulations.

The eLearning course offers:

Interactive content
Knowledge Checks
Scenarios to apply your knowledge
Post Assessment
Certificate of Completion

To sample an interactive demo or to purchase the full course, visit our store here. Contact us for information about training your team with our convenient and affordable off the shelf enterprise options.

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- The Clinical Pathways Team

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