Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Wednesday, October 2, 2019
8:00 a.m.-5:00 p.m.
FDA 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: 

  • This workshop addressed current barriers to expeditious pJIA drug development and steps to overcome them.

  • Specific topics included extrapolation, trial design considerations, dose selection, modeling and simulation, and level of evidence required to establish safety and effectiveness in pediatric patients with pJIA.

View video from each of the four sessions:

View the meeting agenda.

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

 

 

December 2019

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