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09441 New Drug Product Development and Lifecycle Management
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 Faculty 
 Continuing Education 
 Registration Fees 
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Title:
New Drug Product Development and Lifecycle Management

Date(s) And Time(s):
Sep 24 2009 8:00AM - Sep 25 2009 12:30PM

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

Interest Area(s):
Clinical Safety/Pharmacovigilance, Clinical Research, Project Management, 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:
09441

Contact Information:

For detailed program information including faculty and topics, please contact:

Laura Parker

Tel. 215-442-6101

Email Laura.Parker@diahome.org

 

If you have not received confirmation within 5 business days, please contact:

Tim Hershey

Fax 215-442-6105

Email Tim.Hershey@diahome.org