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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

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The State of Pediatric Research in the United States

Session Chair(s)

Chin Koerner, MS

Executive Director, Development and Regulatory Policy

Novartis , United States

Pediatric research in the US has been evolving for the past 20 years. With the 2012 passage of permanant legislation to support pediatric research we are at the dawn of a new age to enable the availability of medicines for children.

Learning Objective : Define the US legal and regulatory framework for mandatory and voluntary pediatric studies; Discuss the efforts to build an infrastructure to enable such reseach to be conducted; Identify collaborative efforts being made by stakeholders to ensure future success of pediatric research efforts.

Speaker(s)

The Best Pharmaceuticals for Children Act: FDA/NIH Collaboration to Increase Pediatric Information in Product Labeling

Donna Snyder, MD

WCG, United States

Executive Physician

FDA Perspective

Rosemary M. Addy, MHS

FDA, United States

Supervisory Consumer Safety Officer, Office of New Drugs, CDER

Industry Perspective

Ronald Portman, MD

Clinical Development & Analytics, Novartis Pharmaceuticals Corporation, United States

Executive Director, Pediatric Development, Science and Innovation

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