Introduction to Drug Development eLearning Module
The Introduction to Drug Development module 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.
Credit Information
ACPE: 1.0
1.0 PMI
0.1 IACET
1.0 PMI
0.1 IACET
Description
Learning Objectives
Upon completion of this module, learners should be able to:
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
- An Expensive and Risky Proposition;
- Regulations;
- Functional Areas;
- Workstreams;
- Timeline;
- Review;
- Case Study