Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Wednesday, October 2, 2019
8:00 a.m.-5:00 p.m.
FDAs White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Silver Spring, MD 20993-0002
301 405 0285
The FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) is announcing a one-day public workshop, “Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)”.
Goals and Objectives:
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.
Clinicians, investigators, clinical pharmacologists, patients and parents of patients, device manufacturers, pharmaceutical companies, contract research organizations, non-profit organizations focused on arthritis and regulators are encouraged to attend.
Reigstration is required.
View the meeting agenda.
If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at email@example.com 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 firstname.lastname@example.org
For More Information:
Access the meeting agenda.
Don't forget to: Register here
If you have any additional questions about this workshop, please contact email@example.com