Pediatric Safety Surveillance Workshop
As part of our focus on creating safer testing methodology and therapeutic outcomes, Critical Path Institute collaborated with the FDA Office of Pediatric Therapeutics to host a workshop on Pediatric Safety Surveillance which was held in Washington D.C. on September 13-14, 2010 and featured opening remarks by Josh Sharfstein, MD, Principal Deputy Commissioner, FDA.
Data on pediatric safety are difficult to collect because of numerous challenges relating to informed consent, determination of consistent and reliable endpoints, the availability of a large patient population at any one center, and funding.
With this workshop, the FDA invited expert feedback and participation in obtaining a better understanding of existing safety databases which are either pediatric focused or include pediatric data to (1) inform and enrich the review of adverse events as mandated by Congress and (2) provide FDA with the tools to research potential pediatric safety signals.
Workshop Presentations
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Title - National Poison Data System (NPDS) Pediatric Drug Safety Monitoring Author - Alvin C. Bronstein MD, FACEP Date - 9-13-10
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Title - Novel Technologies for Drug Safety Surveillance Author - John S. Brownstein, BSc, MPhil, PhD Date - 9-13-10
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Author - Daniel Budnitz, MD, MPH, CDR, USPHS Date - 9-13-10
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Title - Genomic Approaches to Adverse Drug Reactions in Children Author - Bruce C. Carleton, BSc, PharmD Date - 9-13-10
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Title - The PECARN Incident Reporting System Author - James Chamberlain, MD Date - 9-13-10
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Title - FDA's Unique Device Identification Program Author - Jay Crowley, PhD Date - 9-13-10
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Title - KP Center for Effectiveness & Safety Research Author - Robert L. Davis, MD, MPH Date - 9-13-10
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Title - Using HCUP Resources for Pediatric Safety Surveillance Author - Anne Elixhauser, PhD Date - 9-13-10
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Title - PEDSNet: Lessons Learned Sharing EHR Data Among Children's Hospitals Author - Christopher B. Forrest, MD, PhD Date - 9-13-10
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Title - Pediatric Medical Devices: The FDA Postmarket Perspective Author - Thomas P. Gross, MD, MPH Date - 9-13-10
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Title - The Children's IQ Network Author - Brian Jacobs, MD Date - 9-13-10
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Title - Automating Safety Detection and Surveillance: The Automated Adverse Event Detection Project (AAEDP) Author - Eric S. Kirkendall, MD Date - 9-13-10
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Title - The HMO Research Network: Opportunities for Collaboration Author - Tracy Lieu, MD, MPH Date - 9-13-10
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Title - Strengths and Limitations of the Office of Surveillance and Epidemiology's (OSE) Current Systems Author - Ann W. McMahon, MD, MS Date - 9-13-10
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Title - Pediatric Safety: Better Surveillance for Children Author - Dianne Murphy, MD, FAAP Date - 9-14-10
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Title - Limitations of the Pediatric Randomized Trial for Assessing Safety Author - Robert T O'Neill, PhD Date - 9-14-10
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Title - FDA's Sentinel Initiative: A National Strategy for Monitoring Midecal Product Safety Author - Jusy Racoosin, MD, MPH Date - 9-14-10
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Title - Pediatrix Medical Group: Baby Steps and the Clinical Data Warehouse Author - Brian Smith, MD, MPH, MHS Date - 9-14-10
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Title - Utilizing Automated Adverse Event Detection Author - David Stockwell, MD, MBA Date - 9-14-10
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Title - Development of a Pediatric Trigger Tool to Identify Adverse Drug Events Author - Glenn Takata, MD, MS Date - 9-14-10
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Title - Pediatric Safety Surveillance: Ways Forward Author - Marietta Anthony, PhD Date - 9-14-10
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