- September 17-18, 2017
08:00 PM - 08:00 PM EDT
September 18-19, 2017
8:30 a.m. to 5:00 p.m
DoubleTree by Hilton Hotel – Silver Spring
8727 Colesville Road (Route 29), Silver Spring, MD 20910
The Office of Pediatric Therapeutics, Food and Drug Administration (FDA) is announcing a public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Application of “Big Data” to Pediatric Safety Studies”. 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.
In this workshop, the FDA will gather information on the latest developments in “Big Data” from the perspective of a number of stakeholders and expand the conversation to include the utility and challenges associated with the use of “Big Data” in the pediatric setting.
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.
- ADEPT Public Workshop final agenda, September 18-19, 2017
- Federal Register notice
- Speakers' biographies
- Webcast Public Workshop – ADEPT Application of “Big Data” to Pediatric Safety Studies September 18, 2017 Part 1
- Webcast Public Workshop – ADEPT Application of “Big Data” to Pediatric Safety Studies September 18, 2017 Part 2
- Webcast Public Workshop – ADEPT Application of “Big data” to Pediatric Safety Studies September 19, 2017 Part 1
- Webcast Public Workshop – ADEPT Application of “Big data” to Pediatric Safety Studies September 19, 2017 Part 2
For questions regarding the workshop content please contact:
Renan A. Bonnel Pharm.D, MPH, BCPS
Office of Pediatric Therapeutics
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993–0002