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Introduction to Drug Development

Learn the activities required to move a drug candidate from idea to the market, and how various functional areas are organized and contribute at each stage of development. Learn about the regulatory environment in which these activities occur.


Overview

The Introduction to Drug Development module (formerly titled Overview of Drug Development) is part of the DIA Drug Development and Lifecycle Management eLearning Program. This 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. The module also discusses the regulatory environment in which these activities occur.

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

  • An Expensive and Risky Proposition
  • Regulations
  • Functional Areas
  • Workstreams
  • Timeline
  • Review
  • Case Study

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:

  • Describe the use of a Target Product Profile (TPP) as a tool in designing a drug development program
  • 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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Questions?