New Drug Product Development and Lifecycle Management

Venue: DIA

Location: Horsham, Pennsylvania, United States

Event Date/Time: Aug 06, 2012 End Date/Time: Aug 07, 2012
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Description

This course explains the phases, major work streams, key players, and interrelationships necessary to develop new pharmaceuticals and to expand the lifecycle of in-line products. Interactive exercises include creating a simple pharmaceutical development plan based on the desired target product profile.


What You Will Learn Drug development process
Candidate identification/preclinical testing
Phases 1, 2, 3, and 4 pertaining to regulatory review and lifecycle management


Learning Objectives Participants who complete this course should be able to:

Explain how a desired drug product label dictates the components of the drug development plan
Identify the five major work streams 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, biologic, and drug device development
List where to find additional information on biologic and drug device development


Faculty
Courtland R. LaVallee, MBA
Director, Project Management
Theravance, Inc., United States

Venue