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Drug Development Phase 1

Examine the activities associated with phase 1 developnment, with a focus on the drivers that impact the design of the first-in-human study.


Overview

The Drug Development Phase 1 module (formerly titled Phase 1 Studies) is part of the DIA Drug Development and Lifecycle Management eLearning Program. In this module, learners will be taken through the activities associated with phase 1 development, with a focus on the drivers that impact the design of the first-in-human study. 

Estimated time to complete module: 1 hour

This eLearning module can be purchased individually or as part of the Drug Development and Lifecycle Management eLearning Program.

 

Featured topics

  • Objectives and Key Players
  • The IND and CTA
  • Phase 1 Studies
  • Phase 1 Decisions
  • Review

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

Learning objectives

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

  • Outline the key objectives of phase 1 studies
  • Describe the regulatory submissions required for phase 1 studies
  • List key activities that need to be completed before first-in-human clinical trials can begin
  • Explain risk-return decisions involved in phase 1 studies

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