Friday, November 16: 8:00 a.m. - 5:00 p.m.
FDA's White Oak Campus
10903 New Hampshire Avenue
Building #31 - Room 1503A
Silver Spring, MD 20903
* Remote viewing available
This workshop is open to the public with no cost to attend, but registration is still required. Clinicians, investigators, patients and parents of patients, device manufacturers, pharmaceutical companies, contract research organizations and regulators are encouraged to attend. The current agenda is available online.
Goals and Objectives:
- 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.
Agenda, Accommodations, Directions, and Parking Information:
Information regarding FDA lodging, ground transportation, airport information, directions, security, parking, and FAQs is available online.
Remote Access Information/Instructions/Webcast Registration (pre-registration is required):
This public workshop will be available to view via webcast but pre-registration is still required. To access the live webinar, please use the following link: https://collaboration.fda.gov/e3x31jdtudu/event/registration.html. You must log in with your username and password which you create when you register. You must pre-register at least one day before the event to ensure that you have access to the link.
For questions and reasonable accommodations:
For questions, please contact Dr. Jacquline Yancy.