|
The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a one-day public workshop entitled “Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)” on October 2, 2019.
The objectives of this workshop are to:
- Discuss the current barriers to expeditious pJIA drug development and steps to overcome them.
- Discuss specific topics related to 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, regulators, etc. are encouraged to attend.
Date: October 2, 2019
Time: 8:00 am – 5:00 pm
Location: FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Silver Spring, MD 20993
Additional information about this workshop, including registration, webcast instructions, and parking and directions, is available at https://go.usa.gov/xy2ec.
Registration to attend in-person or view the webinar is free. Individuals who wish to view the webcast are still required to complete registration for the conference.
If you have any additional questions about this workshop, please contact cersi@umd.edu.
No hay comentarios:
Publicar un comentario