Greetings NMusers,
The Food and Drug Administration (FDA) in Collaboration with The University of
Maryland Center of Excellence in Regulatory Science and Innovation (CERSI) 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 University of
Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), is
holding a public workshop on June 1st, 2016 titled Quantitative Assessment 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 provide a forum for
discussion on the use of modeling and simulation for systematic assessment of
extrapolation assumptions. The purpose of this public workshop is to provide
an opportunity for relevant stakeholders, including clinicians, academia,
industry and FDA to discuss systematic assessment of data needed to support
extrapolation of efficacy in pediatric product development. 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
extrapolation assumptions in pediatric product development, including the use
of clinical trial simulation and Bayesian approaches.
* Examples in partial onset seizures, inflammatory bowel diseases, and
polyarticular juvenile idiopathic arthritis will be presented and discussed.
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.
Seating will be limited, so early registration is recommended.
For more information, please visit:
http://www.pharmacy.umaryland.edu/centers/cersievents/pedsextrapolation/
For further information contact: Lily Mulugeta (email:
[email protected]<mailto:[email protected]>)
Best Regards
Nitin
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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, FDA
10903 New Hampshire Ave, Bldg 51, Rm 3199
Silver Spring, MD-20993
E-mail: [email protected]<mailto:[email protected]>
Phone: 301-796-0976
Cell: 301-802-5329
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