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Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints Public Workshop Announcement

FDA’s Division of Pediatric and Maternal Health in CDER and The University of Maryland CERSI, is announcing a 1-day public workshop, “FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure:  Extrapolation, Clinical Trial Design, and Endpoints”.  The purpose of this  workshop is to address challenges related to the evaluation of products in pediatric heart failure including population to study, endpoints, and extrapolation of adult efficacy data.  The workshop will also provide a forum for discussion on the use of registry data, as well as alternative trial designs and statistical methods.

The public workshop will be held on:

Date:  October 27, 2017
Time:  8:00 am to 5:00 pm

Location: 

The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503A, Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed.  For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.

Webcast:

M-CERSI Events

Registration: 

To register for the public workshop, visit the following website: M-CERSI Eventsdisclaimer icon.  Registrants will receive confirmation when they have been accepted.  There will be no on-site registration.
There is a registration fee to attend this public workshop in person.  Seats are limited and registration will be on a first-come, first-served basis.  The cost to attend in person is as follows:

Category

Cost

Industry Representative

$50

Nonprofit Organization and Academic Other Than University of Maryland

$50

University of Maryland, College Park and Baltimore

$0

Federal Government

$0

If you need special accommodations due to a disability, please contact Jacquline Yancy (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance.

More Information:  Contact Jacquline Yancy, (301)796-7068;  e-mail Jacquline.Yancy@fda.hhs.gov  or Denise Johnson-Lyles, (301)796-6169; e-mail denise.johnson-lyles@fda.hhs.gov

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