Mark your calendars for a workshop jointly sponsored by the Food and Drug Administration (FDA) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).
Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) Wednesday, October 2, 2019 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. Location/time: FDA's White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD, from 8:00 a.m. to 5:00 p.m. Registration is required to attend. Remote participation will be provided. For the workshop agenda and registration information, please use the link below: https://cersi.umd.edu/event/14346/accelerating-drug-development-for-polyarticular-juvenile-idiopathic-arthritis-pjia Best, Lily Mulugeta, Pharm.D Associate Director, Division of Pediatric and Maternal Health Office of New Drugs Center for Drug Evaluation and Research, FDA yeruk.mulug...@fda.hhs.gov<mailto:yeruk.mulug...@fda.hhs.gov>
