New Drug Product Development and Lifecycle Management

Venue: Drug Information Association, Inc

Location: Horsham, Pennsylvania, United States

Event Date/Time: Oct 13, 2011 End Date/Time: Oct 14, 2011
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Description

At the end of this two-day course, you will be able to explain the phases, major work streams, key players and interrelationships within the new drug development and lifecycle management processes. Interactive exercises include creating a simple drug development plan based on the desired target product profile.



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


Learning Objectives:
At the conclusion of this course, participants should be able to:
Explain how a desired drug product label dictates the components of the drug development plan
Identify the 5 major workstreams that must be completed in any drug development program and describe their interactions
Create the timeline for key functional area players in the 6 phases of drug development
Discuss the life cycle management process and how product line extensions are developed
Identify the differences among drug, biologic, and drug device development and recognize where to find additional information on biologic and drug device development


Target Audience:

Project managers and team members who wish to learn more about drug development


Event Code:
11412

Venue

Enterprise Drive Suite 200
Horsham
Pennsylvania
United States
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