Drug Development Phase 3 and Regulatory Review
Drug Development Phase 3 and Regulatory Review is organized by Drug Information Association (DIA). This Conference has been approved for a maximum of 1.5 contact hour or .15 CEUs.
Release Date: July 14, 2021
Expiration Date: July 13, 2024
Who should attend?
This module is designed for individuals who are new to, or changing roles in, the pharmaceutical and biotechnology industries. The module will also benefit professionals who work in the areas of:
• Clinical Research
• Project Management
• Administrative Support
• Quality Assurance
• Regulatory Affairs
• Manufacturing
• Medical writing
• Business Support
Course Description:
In the Drug Development Phase 3 and Regulatory Review module (formerly titled Phase 3 Studies and Regulatory Review), learners will review clinical study activities that occur during phase 3, and the regulatory requirements for and components of an application for marketing approval in the US and EU.
Learning objectives:
Upon completion of this module, learners should be able to:
• Outline the clinical study activities of phase 3
• Explain safety reporting requirements
• Discuss the regulatory review process in the US and Europe
• Detail the components of the CTD
Additional details will be posted as soon as they are available.