概览

In the Drug Development Phase 3 and Regulatory Review module, 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.

精选主题

- Objectives and key players
- Phase 3 activities
- Safety reporting requirements
- Regulatory review
- The Common Technical Document
- Case study
- Review

谁应该参加？

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

学习目标

Upon completion of this module, learners should be able to:
- List the clinical study activities of phase 3
- Identify safety reporting requirements
- Determine the regulatory review process in the US and Europe
- Record the components of the CTD

注册

Drug Development Phase 3 and Regulatory Review

概览

精选主题

谁应该参加？

学习目标

获得信息并保持参与