- October 02, 2019
08:00 AM - 05:00 PM EDT
The Divisions of Pulmonary, Allergy, and Rheumatology Products and Pediatric and Maternal Health, in collaboration with the University of Maryland CERSI, is announcing a 1-day public workshop, “Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)”. The aim of the workshop will be to discuss current barriers to expeditious pJIA drug development and steps to overcome them. Specific topics will include extrapolation, trial design considerations, dose selection, modeling and simulation, and level of evidence required to establish safety and effectiveness in pediatric patients with pJIA.
The public workshop will be held on:
Date: Wednesday, October 2, 2019
Time: 8:00am to 5:00pm
The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, 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.
Registration: This workshop is open to the public with no cost to attend, but registration is still required. See M-CERSI EventsExternal Link Disclaimer for registration, agenda and webcast access.
Special Accommodations: If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at firstname.lastname@example.org at least seven (7) days in advance of the workshop. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made two (2) weeks in advance of the workshop, and should be sent directly to the FDA Interpreting Services Staff at email@example.com
Session 1: https://collaboration.fda.gov/pr6m655e6dhg/
Session 2: https://collaboration.fda.gov/p1ijqbtt7jqs/
Session 3: https://collaboration.fda.gov/pypke3r9mjp6/
Session 4: https://collaboration.fda.gov/pptz0mlrkzp8/