Joint CERSI and FDA workshop on Pediatric Inflammatory Bowel Disease Announcement

Hi All, I wanted to let you know that a new collaborative workshop hosted by the UMD Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the 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 Inflammatory Bowel Disease (IBD) Workshop". 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. 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 is 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