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Public Workshop- Advancing the Development of Pediatric Therapeutics (ADEPT...

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DoubleTree by Hilton Hotel

8727 Colesville Road (Route 29)

Silver Spring, Maryland 20910

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The purpose of this two day workshop is to understand: 1) how to access and analyze “Big Data” associated with safety information in the healthcare setting. 2) the utility and challenges associated with the use of “Big Data” to study the safety of therapeutics in children.

Large volumes of data in the context of the healthcare industry have the potential to provide additional information related to medication use which may affect the benefit-risk assessment of medicines in general and pediatric medicines in particular. Since pediatric pharmacoepidemiologic studies tend to enroll fewer patients than adult studies, additional information may be needed to better understand the safety and efficacy of use of these drugs in children. “Big Data”, including forms of real world evidence that may involve large and complex data sets, may be particularly useful as a supplement to traditional studies. Supplementary information may include additional clinical trial data, registry data, and electronic health record information.

Day 1 will focus on national and international uses of “Big Data” in healthcare.

Day 2 will focus on “Big Data” utility in the pediatric setting, including specific challenges associated with pediatric data.

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DoubleTree by Hilton Hotel

8727 Colesville Road (Route 29)

Silver Spring, Maryland 20910

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