Drug Development Phase 3 and Regulatory Review
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.
Estimated time to complete module: 1.5 hours
This eLearning module can be purchased individually or as part of the Drug Development and Lifecycle Management eLearning Program.
- Objectives and Key Players
- Phase 3 Activities
- Safety Reporting Requirements
- Regulatory Review
- The Common Technical Document
- Case Study
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
- Medical writing
- Business Support
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