| The U.S. Food and Drug Administration (FDA) Division of Pediatrics and Maternal Health and Complex Innovative Trial Design Pilot Meeting Program in the Center for Drug Evaluation and Research (CDER) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled "Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design". The purpose of this workshop is to discuss opportunities for leveraging complex and innovative trial designs, understand the challenges with their applications, and develop solutions on how challenges in the designs can be overcome. The workshop will specifically focus on two topics of interest: bridging biomarkers in pediatric extrapolation and Bayesian techniques in pediatric studies. In addition, the workshop will allow for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations. The date, time, and location of the workshop are as follows: Date: September 1 & 2, 2021 Time: 10:00 AM - 3:00 PM ET both days Location: This public workshop will be held in virtual format only. Agenda and Registration: To access the agenda and registration for the public workshop, visit the following website: https://cersi.umd.edu/event/16424/advancing-the-development-of-pediatric-therapeutics-adept-7. Registrants will receive confirmation when they have been accepted. There is no registration fee to attend this public workshop. Webcast Link: https://cersi.umd.edu/event/16424/advancing-the-development-of-pediatric-therapeutics-adept-7 If you have any additional questions about this workshop, please contact Lily Mulugeta at yeruk.mulugeta@fda.hhs.gov. To learn more about the FDA's Complex Innovative Trial Design Pilot Meeting Program, visit the FDA complex-innovative trial design pilot meeting program website. | 
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