Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age
Wednesday, October 13, 2021 - 10:00am to Thursday, October 14, 2021 - 2:00am
Virtual
Collaborative workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)
The event will take place virtually on Wednesday, October 13 and Thursday, October 14, from 10:00 a.m. - 2:00 p.m. EST each day.
About the Event:
Analgesic trials in pediatric patients present scientific, ethical and practical challenges. The aim of the workshop is to have an open dialogue between regulators, academic researchers and drug developments around these complex pediatric research trials. The workshop will include several short talks and provide interactive sessions to address unique aspects of leveraging adult data and provide an overview of innovative trial design. The session will evaluate and discuss paths to advance the development of analgesics for pediatric patients especially those under 2 years of age. The workshop will be held in collaboration with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine.
The workshop will be open to the public. Additional information coming soon.
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $25,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
Contact Ann Anonsen (aanonsen@umd.edu) with any questions.
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