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[NMusers] Joint CERSI and FDA workshop on Pediatric Inflammatory Bowel Disease Announcement

From: Diane Mould <drmould_at_pri-home.net>
Date: Fri, 17 Aug 2018 15:39:49 +0000

Hi All,
I wanted to let you know that a new collaborative workshop hosted by the UM=
D Center of Excellence in Regulatory Science and Innovation (M-CERSI) and t=
he U.S. Food and Drug Administration (FDA) will be held on Friday, November=
 16 from 8:00 a.m. - 5:00 p.m. The workshop is titled "Pediatric Inflammat=
ory Bowel Disease (IBD) Workshop". The aim of the workshop will be to disc=
uss current barriers to expeditious pediatric IBD drug development and step=
s to overcome them. Specific topics will include a review of the legislatio=
n relevant to pediatric trials, extrapolation, trial design considerations,=
 dose selection and the level of evidence required to establish safety and =
effectiveness in pediatric patients with IBD.
I would recommend that any modelers who have worked conducting analyses to =
help extend drug use in to pediatric patient populations consider attending=
. Note that remote viewing is also available. The website to learn more i=
s https://cersi.umd.edu/pediatricIBD.
I hope to see you all there
Best
Diane

Diane R Mould PhD FCP FAAPS
Projections Research Inc
535 Springview Lane
Phoenixville PA 19460
Cell: +1 703 919 1715
Fax: +1 610 917 2280
www.pri-home.net



Received on Fri Aug 17 2018 - 11:39:49 EDT

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