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Drug Development Phase 3 and Regulatory Review

Review phase 3 clinical study activities and the regulatory requirements and components of an application for marketing approval in the US and EU.

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概要

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.

特集トピック

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

参加対象

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

学習目的

  • At the conclusion of this course, participants 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
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