-
Clinical and CMC 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, prescribers had to rely on estimating appropriate dosages of approved medications for pediatric patients from approved dosage regimens in adults 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 indicated in the pediatric population, studies 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. Therefore, regulatory agencies recognize the use of a population pharmacokinetic approach as a viable approach for extrapolating safety and efficacy in children from adequate and well-controlled studies in adults. This session will review the current legislative and regulatory landscape of pediatric drug development in the US and the E.U., as well as formulation composition related challenges associated with conducting studies in the 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