New Drug Product Development and Lifecycle Management

Date(s) And Time(s):
Oct 13 2011 8:30AM - Oct 14 2011 12:45PM

Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Overview:

Develop New Drugs While Expanding the Lifecycle of Inline Products

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

Contact Information:

For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183
Email Susan.Mazak@diahome.org

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr... Course