Drug Development Phase 1 Course
Drug Development Phase 1 Course is organized by Drug Information Association (DIA).
Release Date: June 2, 2021
Expiration Date: June 1, 2024
Course Description:
The Drug Development Phase 1 module (formerly titled Phase 1 Studies) is part of the DIA Drug Development and Lifecycle Management eLearning Program. In this module, learners will be taken through the activities associated with phase 1 development, with a focus on the drivers that impact the design of the first-in-human study.
Learning objectives:
Upon completion of this module, learners should be able to:
• Outline the key objectives of phase 1 studies
• Describe the regulatory submissions required for phase 1 studies
• List key activities that need to be completed before first-in-human clinical trials can begin
• Explain risk-return decisions involved in phase 1 studies