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Nov. 16 M-CERSI Workshop: Advancing Drug Development in Pediatric IBD

An M-CERSI workshop titled “Advancing Drug Development in Pediatric Inflammatory Bowel Disease (IBD)” will be held Nov. 16 at the Food and Drug Administration’s (FDA) White Oak Campus in Silver Spring, Md.

This collaborative workshop, hosted by the Centers of Excellence in Regulatory Science and Innovation (CERSI) and the FDA, is open to the public with no cost to attend, but registration is required.

The aim of the workshop will be to discuss current barriers to expeditious pediatric IBD drug development and steps to overcome them. Specific topics will include a review of the legislation 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.

  • Date: Friday, Nov. 16
  • Time: 8 a.m. to 5 p.m.
  • Where: FDA’s White Oak Campus, 10903 New Hampshire Ave., Building No. 31, Room 1503A, Silver Spring, MD 20903
  • Registration: Go to this link.
  • More information: Visit this webpage.
  • Note: Remote viewing will be available, but registration is required.
Erin MerinoClinical Care, Education, People, Research, UMB NewsOctober 19, 20180 comments

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