New Drug Product Development & Lifecycle Management

Date(s) And Time(s):
Oct 19 2010 8:00AM - Oct 20 2010 12:30PM

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

Interest Area(s):
Clinical Safety/Pharmacovigilance, Clinical Research, Regulatory Affairs

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:
10432

Contact Information:

For detailed program information including faculty and topics, please contact:
Laura Parker
Tel. +1-215-442-6101
Email Laura.Parker@diahome.org

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