Fueled by the encouragement from regulatory agencies in the United States 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 US 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. The web seminar will examine these regulatory initiatives and discuss practical and effective development approaches and study designs.
- Identify recent regulatory initiatives that encourage 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
- Project team, clinical team, and study team members
- Individuals moving into the drug development area
- Clinical investigators working with pharmaceutical companies
Robert L. Kunka, Ph.D.
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3 hours; 12:30 - 3:30 p.m. Eastern
December 6, 2010