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

From: Mulugeta, Yeruk <Yeruk.Mulugeta_at_fda.hhs.gov>
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=


Lily Mulugeta, Pharm.D
Associate Director, Division of Pediatric and Maternal Health
Office of New Drugs
Center for Drug Evaluation and Research, FDA

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

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