Mark your calendars for Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics, a one-day public workshop jointly sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA).
About the Event:
Scheduled for Wednesday, June 1, 2016 from 8:00 a.m. to 5:00 p.m., Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics will examine quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. It will provide an opportunity for relevant stakeholders, including representatives from academia, government, non-profit organizations, and industry, to discuss the systematic assessment of data needed to support extrapolation of efficacy in pediatric product development. Specifically, the workshop will address:
- Presentations on approaches for assessing disease and therapeutic response similarity between adults and pediatrics
- Discussion of alternative approaches to the assessment of extrapolation assumptions in pediatric product development, including the use of clinical trial simulation and Bayesian approaches
This event will be held at the FDA's White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD. It will take place in Building 31, Room 1503.
About the Organizers:
|A collaborative partnership between the University of Maryland, College Park and the University of Maryland, Baltimore, with support from the Food and Drug Administration (FDA), the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.
|The Food and Drug Administration (FDA) works to protect the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. The organization also strives to advance public health by helping to speed innovations that make medicines more effective, safer, and more affordable.