Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics

Wednesday, June 1, 2016
8:00 a.m.-5:00 p.m.
FDA White Oak Campus, The Great Room Bldg.#31, 10903 New Hampshire Avenue, Silver Spring, MD
Ann Anonsen
301 405 0285
aanonsen@umd.edu

For more information and to register, please visit: http://pharmacy.umaryland.edu/centers/cersievents/pedsextrapol ation/

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.

 Registration Fees:

 The cost to register for this event is determined by the participant type. Please review the fee structure provided below to determine if you will be require to submit a payment with your registration. 

  • UMB and UMCP Faculty, Staff, and Students: FREE
  • Federal Government Employees: FREE
  • Non-Profit Organizations and Academia Representatives (Excluding the University of Maryland): $50.00
  • Industry Representatives: $50.00

 Webcast Streaming:

This public workshop will also be available to view via webcast. There is no registration fee for individuals who want to access the workshop via the webcast, but registration is still required.

If you have never attended a Connect Pro event before, please test your connection here. For a quick overview of the Connect Pro program, please visit this webpage.

 How to Register:

 FDA Attendees

  Full-Time-Employees (FTEs):  Register by using this link: (https://lms.learning.hhs.gov/Saba/Web/Main/goto/RegisterCatalog?offeringId=class000000000114218&oneClickLearningON=true). The webcast link will be provided by e-mail after you have registered.

  FDA Contractors/FDA ORISE Fellows:  Please contact Shari Solomon at Shari.Solomon@fda.hhs.gov to register.

 Non-FDA Attendees

If you register as a webcast attendee, the webcast link will be provided to you by e-mail after you have registered for the workshop.

 For more information and to register, please visit:

http://pharmacy.umaryland.edu/centers/cersievents/pedsextrapolation/registration/

 

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