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.
- 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
- 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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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-10-037-L01-P. Released: 9/10.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.