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[NMusers] FDA Workshop on Drug Development in Pediatric Inflammatory Disease: Dose Selection, Exposure-response data, Extrapolation, and Innovative Trial Designs

From: Mulugeta, Yeruk <>
Date: Wed, 10 Oct 2018 20:20:13 +0000

Mark your calendars for a workshop jointly sponsored by the Food and Drug A=
dministration (FDA) and the University of Maryland Center of Excellence in =
Regulatory Science and Innovation (M-CERSI).

Drug Development in Pediatric Inflammatory Disease

Friday, November 16, 2018

The workshop will discuss current barriers to expeditious pediatric IBD dru=
g development and steps to overcome them. Specific topics will include a r=
eview of the legislation relevant to pediatric trials, extrapolation, trial=
 design considerations, dose selection and the level of evidence required t=
o establish safety and effectiveness

Location/time: FDA's White Oak Campus, located at 10903 New Hampshire Aven=
ue in Silver Spring, MD, from 8:30 a.m. to 5:00 p.m.

Registration is required to attend. Remote participation provided.

For the workshop agenda and registration information, please use the link b=
Pediatric Inflammatory Bowel Disease (IBD) Workshop | Center of Excellence =
in Regulatory Science and Innovation<>


Lily Mulugeta, Pharm.D
Associate Director, Division of Pediatric and Maternal Health
Office of New Drugs
Center for Drug Evaluation and Research, FDA<>

Received on Wed Oct 10 2018 - 16:20:13 EDT

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