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Overview of Drug Development


Overview

This module is part of the DIA Drug Development and Life Cycle Management eLearning Program. The Overview of Drug Development module provides a grounding in the breadth of activities required to move a potential drug candidate from idea to the marketplace, with an emphasis on how various functional areas contribute at each stage of development, and how they are organized.  It also discusses the regulatory environment in which these activities occur.

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:

  • Describe the phases of drug development
  • Identify the sources of drug development regulations
  • List the functional areas involved in the drug development process
  • Describe the workflow for bringing a new drug to market

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