martes, 12 de septiembre de 2017

Announcement: October 27, 2017: Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints (FDA CDER and University of Maryland CERSI Collaborative Workshop)

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 FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure:  Extrapolation, Clinical Trial Design, and Endpoints

Mark your calendars for Drug Development in Pediatric Heart Failure: Extrapolation, Clinical TrialDesign and Endpoints, a workshop jointly sponsored by the University of Maryland Center ofExcellence in Regulatory Science and Innovation (M-CERSI) and the Food and DrugAdministration (FDA).
Scheduled for Friday, October 27, 2017, Drug Development in Pediatric Heart Failure:Extrapolation, Clinical Trial Design and Endpoints will address challenges related to evaluationof products in pediatric heart failure including population to study, endpoints, and extrapolationof adult efficacy data. The workshop will also provide a forum for discussion on the use ofregistry data as well as alternative trial designs and statistical methods.
 The workshop will be held in Building 31, Room 1503 (the Great Room) at the FDA’s White OakCampus, located at 10903 New Hampshire Avenue in Silver Spring, MD, from 8:00 a.m. to 5:00p.m. It is open to the public. Registration is required to attend.

For more information, please visit  http://www.cersi.umd.edu/events/index.php?mode=4&id=12500


Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration

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