FDA Workshop on Pediatric Innovative Trial Design (Sept 1 & 2)

FDA will hold a virtual public workshop on September 1-2 entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.”

The workshop is being organized in collaboration with FDA’s CID Pilot Program and will discuss applications of complex and innovative trial designs in pediatric clinical trials. The workshop will specifically focus on two topics of interest:

• Day 1: Bridging biomarkers in pediatric extrapolation
• Day 2: Bayesian techniques in pediatric studies

Early registration is recommended because space is limited; therefore, FDA may limit the number of participants from each organization. To register go to: https://cersi.umd.edu/event/16424/advancing-the-development-of-pediatric-therapeutics-adept-7