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Phase 3 Studies and Regulatory Review


Overview

This module is part of the DIA Drug Development and Life Cycle Management eLearning Program. During the Phase 3 Studies and Regulatory Review module, learners will review clinical study activities that occur during Phase 3 studies, and the regulatory requirements for and components of an application for marketing approval in the US and EU.

Estimated time to complete module: 1 hour

 

Who should attend?

This module is designed for individuals who are new to, or changing roles, in the pharmaceutical and biotech industries.   This module will also benefit professionals who work in the area of:

  • Clinical Research
  • Project Management
  • Administrative Support
  • Quality Assurance
  • Regulatory Affairs
  • Manufacturing
  • Medical Writing
  • Business Support

Learning objectives

Upon completion of this module, learners should be able to:

  • Outline the clinical study activities of Phase 3 studies
  • Explain the safety reporting requirements
  • Discuss the regulatory review process in the US and Europe
  • Examine components of the CTD

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