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FDA Public Workshop on Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

From: Mulugeta, Yeruk <Yeruk.Mulugeta>
Date: Thu, 30 May 2019 17:27:00 +0000

Mark your calendars for a workshop jointly sponsored by the Food and Drug A=
dministration (FDA) and the University of Maryland Center of Excellence in =
Regulatory Science and Innovation (M-CERSI).



Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthrit=
is (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 inc=
lude extrapolation, trial design considerations, dose selection, modeling a=
nd simulation, and level of evidence required to establish safety and effec=
tiveness in pediatric patients with pJIA.



Attendance: Clinicians, investigators, clinical pharmacologists, patients =
and parents of patients, device manufacturers, pharmaceutical companies, co=
ntract research organizations, non-profit organizations focused on arthriti=
s and regulators are encouraged to attend.



Location/time: FDA's White Oak Campus, located at 10903 New Hampshire Aven=
ue 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 b=
elow:
https://cersi.umd.edu/event/14346/accelerating-drug-development-for-polyart=
icular-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.mulugeta




Received on Thu May 30 2019 - 13:27:00 EDT

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