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New Drug Product Development and Life Cycle Management

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Overview 

This course explains the phases, major work streams, key players, and interrelationships necessary to develop new pharmaceuticals and to expand the life cycle 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 life cycle management

Who Should Attend 

  • Professionals wishing to broaden their understanding of drug development in the pharmaceutical or biotechnology industry
  • People moving from primarily functional positions into team membership roles
  • People transitioning from other industries or from academia

Learning Objectives 

At the conclusion of this activity, participants 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 life cycle 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

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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