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Pediatric Clinical Drug Development July 2012

Jul 25, 2012
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Course Description

Fueled by the encouragement from regulatory agencies in the U.S. and Europe, the art and science of pediatric drug development has evolved rapidly in pharmaceutical companies over the last few years. Due to recent governmental initiatives such as the Pediatric Research Equity Act (PREA) in the U.S. and Pediatric Investigation Plans (PIPs) in Europe, pharmaceutical companies have been given clear pathways and incentives to develop drug indications and products for this important group of patients. This web seminar will examine these regulatory initiatives and discuss practical and effective development approaches and study designs.

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Learning Objectives

  • Identify recent regulatory initiatives that encourage drug development in pediatrics
  • Examine the limitations of working in this population and how to overcome them
  • Apply adult data to the pediatric population
  • Utilize pharmacokinetic and pharmacodynamic data
  • Examine study designs and approaches successfully used for approval
  • Develop a pediatric plan outline

Who Should Attend

  • Project Team, Clinical Team, and Study Team Members
  • Individuals moving into the drug development area
  • Clinical Investigators working with pharmaceutical companies

Instructor

Robert L. Kunka, Ph.D.

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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

 

 

 

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)