Pediatric Drug Development

Mark your calendars for Pediatric Drug Development: Use of Exposure Matching and Exposure-Response for Extrapolation of Efficacy in Pediatric Product Development, a workshop sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA).

About the Event:

Pharmacists and pharmaceutical researchers from industry, academia, and regulatory agencies are invited to attend Pediatric Drug Development: Use of Exposure Matching and Exposure-Response for Extrapolation of Efficacy in Pediatric Product Development on Thursday, January 22, 2015, from 8:30 a.m. to 5:00 p.m. at the Food and Drug Administration's (FDA) White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD. This one-day workshop will examine current practices and applications of pediatric exposure matching and pediatric exposure-response analyses from a variety of perspectives, with special attention to recommendations for application of these practices in drug development.

About Sponsors:

 Center of Excellence in Regulatory Science and Innovation (CERSI) The University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways in which drugs and medical devices are developed and evaluated. It is a collaborative partnership between the Food and Drug Administration (FDA) and the Baltimore and College Park campuses of the University of Maryland.

For More Information:

More information about this workshop, including an agenda, registration, and information about the White Oak Campus, can be found on this website.