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FDA-M CERSI: Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design Public Workshop

From: Mulugeta, Yeruk <Yeruk.Mulugeta>
Date: Fri, 6 Aug 2021 19:15:35 +0000

Dear Colleagues,
FDA's Division of Pediatrics and Maternal Health and Complex Innovative Tri=
al Design Pilot Meeting Program in CDER and The University of Maryland CERS=
I, are announcing a 2-day public workshop, "Advancing the Development of Pe=
diatric Therapeutics Complex Innovative Trial Design". The purpose of this=
  workshop is to discuss opportunities for leveraging complex and innovativ=
e trial designs, understand the challenges with their applications, and dev=
elop solutions on how challenges in the designs can be overcome. The works=
hop will specifically focus on two topics of interest: bridging biomarkers =
in pediatric extrapolation and Bayesian techniques in pediatric studies. I=
n addition, the workshop will allow for an open dialogue around the use of =
these approaches among regulators, industry, academia, and patient organiza=
The public workshop will be held on:
Date: September 1 and 2, 2021
Time: 10:00 am to 3:00 pm
The public workshop will be held in virtual format only.
Agenda and Registration: To access the agenda and registration for the pub=
lic workshop, visit the following website:
4/advancing-the-development-of-pediatric-therapeutics-adept-7 . Registrant=
s will receive confirmation when they have been accepted.
There is no registration fee to attend this public workshop.

Best regards,

Lily Mulugeta, PharmD

Associate Director, Policy and Research (Acting)

Division of Pediatrics and Maternal Health, ORPURM

Office of New Drugs

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Received on Fri Aug 06 2021 - 15:15:35 EDT

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