CTSA Consortium Child Health Oversight Committee - Pediatric Drugs and Devices
Description: |
The CTSA program currently includes almost 40 pediatric programs with several major children's hospitals in the United States. This consortium will provide a unique platform to provide rapid and effective implementation of device and drug investigations in children. The overarching goal is to develop a platform that is not limited to a single discipline, but that is interoperable with other research programs to maximize flexibility, leverage resources, and ensure scientific excellence, ethical integrity, and regulatory compliance in order to provide safer and more effective therapeutics to children. Some of the planned approaches are: 1) to select or develop outcome assessments that are objective, interpretable, clinically informative, and acceptable to regulatory authorities in all regions; 2) to harmonize regulatory requirements across individual institutions and to set up a consortium to increase subject recruitment and facilitate protocol implementation; 3) to harmonize and align informatics to conform with international standards; 4) to select or develop consistent terminology that would ensure unambiguous implementation and interpretation of data. |
Pediatric Drugs and Devices Participants:
| Co-Chair(s) |
Jonathan M. Davis (Tufts) Donald J. Hagler (Mayo) Steven Hirschfeld (NICHD) |
| NIH Coordinator(s) | Mary Purucker (NCRR) |
| Participation | Click to view |
| Next Meetings |
September 10, 2010 4:00 PM – 5:00 PM October 8, 2010 4:00 PM – 5:00 PM November 12, 2010 4:00 PM – 5:00 PM December 10, 2010 4:00 PM – 5:00 PM |
| Previous Workshops |
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| Previous Meetings (2010) |
August 13, 2010
July 9, 2010 June 11, 2010 May 14, 2010 February 12, 2010 |
| Previous Meetings (2009) |
November 13, 2009
October 23, 2009 September 11, 2009 July 10, 2009 June 12, 2009 March 13, 2009 January 16, 2009 January 9, 2009 |
| Previous Meetings (2008) |
December 19, 2008
December 19, 2008 December 12, 2008 November 14, 2008 October 24, 2008 September 12, 2008 August 15, 2008 June 23, 2008 January 25, 2008 |