-
Clinical and Regulatory Considerations in Pediatric Drug Development
Tuesday, November 13
9:00 am – 11:00 am
Roundtable
ACPE #073-999-07-541-L04
In the past, doctors have relied heavily on estimating appropriate dosages of approved medications for pediatric patients from approved dosage regimens in adults often without appropriate supporting clinical studies in the pediatric population. Regulatory agencies in the United States (U.S.) and the European Union (E.U.) now require that, for drugs that are appropriate for use in the pediatric population, relevant studies must be conducted in that population so that such drugs can be appropriately labeled for use in children. Conducting clinical studies in children can be particularly challenging. This session will examine the approaches used to extrapolate safety and efficacy information from adequate and well controlled studies in adults to children, review the current legislative and regulatory landscape of pediatric drug development in the U.S., including FDA’s experiences to date, the challenges associated with conducting studies in pediatric populations.
Moderator
Sanjay Sehgal, Ph.D.
Wyeth Pharmaceuticals
Regulatory Approaches for Extrapolating Data to the Pediatric Populations
Jethro Ekuta, Ph.D.
Wyeth Pharmaceuticals
FDA Experiences with Pediatric Drug Development
Lisa Mathis, M.D.
U.S. Food and Drug Administration
Clinical & Regulatory Challenges in Pediatric Drug Development
Henrietta Ukwu, M.D.
Wyeth Pharmaceuticals