Elektra is dermatologist by training has been a medical officer at the FDA since 2001 and with SEALD since 2007. Elektra works in clinical outcome assessment review and qualification and has participated in the development of the FDA PRO guidance as well as the DDT qualification guidance.
PRESENTER
(S):
Carla Epps, FDA, United States
Donald Patrick, University of Washington, United States
Description
This session will discuss considerations for selection and/or development of well defined and reliable pediatric clinical outcome assessment tools.
Learning Objectives: Discuss the important considerations for selecting well-defined and reliable clinical outcome assessment tools for use in pediatric populations Discuss planning for pediatric clinical outcome assessment in drug development.