Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Wednesday, October 2, 2019
8:00 a.m.-5:00 p.m.
FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Silver Spring, MD 20993-0002
Ann Anonsen
301 405 0285
aanonsen@umd.edu

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.

Attendance:

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. 

Register here

Access the webcast online.

Special Accommodations:

If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at aanonsen@umd.edu 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 interpreting.services@oc.fda.gov 

For More Information:

Access the meeting agenda.

Don't forget to: Register here 

If you have any additional questions about this workshop, please contact cersi@umd.edu

 

 

July 2019

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