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Phase 1 Studies


Overview

This module is part of the DIA Drug Development and Life Cycle Management eLearning Program. In this comprehensive Phase 1 Studies module, learners will be taken through the activities associated with Phase 1 development, with a focus on the drivers impacting design of the First in Human study.

Estimated time to complete module: .5 hour/30 minutes

 

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, participants 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
  • Examine risk-return decisions involved in Phase 1 studies

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