- November 16, 2018
- 3:00 AM - 12:00 PM ET
- Organized By:
Pediatric Inflammatory Bowel Disease (IBD) Workshop
The Divisions of Gastroenterology and Inborn Errors Products and Pediatrics and Maternal Health, in collaboration with the University of Maryland CERSI, is announcing a 1-day public workshop, “Pediatric Inflammatory Bowel Disease (IBD)”. The aim of the workshop is 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.
The public workshop will be held on:
Date: Friday, November 16, 2018
Time: 8:00am to 5:00pm
The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503A, Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.
- Part 1: https://collaboration.fda.gov/p93ch9arootw/
- Part 2: https://collaboration.fda.gov/p11em375f93f/
- Part 3: https://collaboration.fda.gov/pbnudkn6n9ws/
- Part 4: https://collaboration.fda.gov/pr4m6bijrj09/
Registration: This workshop is open to the public with no cost to attend, but registration is still required. See M-CERSI Events for registration.
If you need special accommodations due to a disability, please contact Jacquline Yancy (see FOR MORE INFORMATION CONTACT) at least 7 days in advance.
More Information: Contact Jacquline Yancy, (301)796-7068; e-mail Jacquline.Yancy@fda.hhs.gov or Gettie Audain, (301) 796-9446; email Gettie.Audain@fda.hhs.gov