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Public Meeting on Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics

From: Mehrotra, Nitin <Nitin.Mehrotra>
Date: Mon, 25 Apr 2016 17:35:01 +0000

Greetings NMusers,

The Food and Drug Administration (FDA) in Collaboration with The University=
 of Maryland Center of Excellence in Regulatory Science and Innovation (CER=
SI) Will Host a Public Meeting on Quantitative Assessment of Assumptions to=
 Support Extrapolation of Efficacy in Pediatrics on June 1st, 2016

The Food and Drug Administration (FDA), in collaboration with the Universit=
y of Maryland Center of Excellence in Regulatory Science and Innovation (CE=
RSI), is holding a public workshop on June 1st, 2016 titled Quantitative As=
sessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.=
  The objective of the workshop is to discuss quantitative and qualitative =
approaches for verifying assumptions pertaining to disease and therapeutic =
response similarity between adults and children. The workshop will also pr=
ovide a forum for discussion on the use of modeling and simulation for syst=
ematic assessment of extrapolation assumptions. The purpose of this publi=
c workshop is to provide an opportunity for relevant stakeholders, includin=
g clinicians, academia, industry and FDA to discuss systematic assessment o=
f data needed to support extrapolation of efficacy in pediatric product dev=
elopment. Specifically, the workshop will include:

* Presentations on approaches for assessing disease and therapeutic=
 response similarity between adults and pediatrics

* Discussion of alternative approaches to the assessment of extrapo=
lation assumptions in pediatric product development, including the use of c=
linical trial simulation and Bayesian approaches.

* Examples in partial onset seizures, inflammatory bowel diseases, =
and polyarticular juvenile idiopathic arthritis will be presented and discu=

Date: Wednesday, June 1st, 2016, 8:00 a.m. - 5:00 p.m.

Location: FDA White Oak Campus, Building 31, the Great Room (Rm. 1503A)

Interested individuals can attend the meeting in person or via Web cast. Se=
ating will be limited, so early registration is recommended.

For more information, please visit:

For further information contact: Lily Mulugeta (email: yeruk.mulugeta<mailto:yeruk.mulugeta

Best Regards

Nitin Mehrotra, M.Pharm., Ph.D.
Pharmacometrics Team Leader
Hematology, Medical Imaging,
Metabolic & Endocrinology and Gastroenterology & Inborn Error Products
Division of Pharmacometrics, Office of Clinical Pharmacology, OTS, CDER, FD=
10903 New Hampshire Ave, Bldg 51, Rm 3199
Silver Spring, MD-20993
E-mail: Nitin.Mehrotra
Phone: 301-796-0976
Cell: 301-802-5329
The contents of this message are mine personally and do not necessarily ref=
lect any position
of the Government or the Food and Drug Administration. This message, includ=
ing attachments,
is for the sole use of the intended recipient(s) and may contain confidenti=
al and privileged information.
Any unauthorized use, disclosure, or distribution is prohibited. If you are=
 not the intended recipient,
please contact the sender and destroy all copies of the original message

Received on Mon Apr 25 2016 - 13:35:01 EDT

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