Overview

Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed. This introductory course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development and minimize the risks associated with shepherding a new drug candidate through the development process.

At the end of this course, you will be able to explain the phases, major workstreams, key players, and interrelationships necessary to develop new drugs in the US and Europe and to expand the lifecycle of in-line products. Interactive exercises will take you through the many decisions faced by an organization as they progress a new drug candidate through development and beyond.

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What you will learn

Drug development process

Candidate identification/preclinical testing

Phase 1

Phase 2

Phase 3 and regulatory review

Phase 4 and lifecycle management

Who should attend?

Professionals who wish to broaden their understanding of drug development in the pharmaceutical or biotechnology industry. This course should be of particular interest to those people who are moving from primarily functional positions into team membership roles or who are transitioning from other industries or from academia.

Learning objectives

At the conclusion of this activity, participants should be able to:

Explain how a desired drug product label dictates the components of the drug development plan
Identify the five major workstreams that must be completed in any drug development program and describe their interactions
Describe the key functional area players and when they contribute to the six phases of drug development
Discuss the lifecycle management process and how product line extensions are developed
Recognize the major differences between drug and biologic development
Discuss the differences in the drug development process between the US and Europe
List where to find additional information on biologic and drug device development

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