Overview
of the ECG Warehouse and Review Process
Public Workshop
Date: Friday, September 30, 2005
Time: 9:30 a.m. – 11:30 a.m.
Location:
Food & Drug Administration
Center for Drug Evaluation and Research
Advisory Committee Conference Room
5630 Fishers Lane, Room 1066
Rockville,
MD 20852
The Food and
Drug Administration (FDA) is announcing a public workshop entitled:
Overview of the ECG Warehouse and Review Process. The
purpose of the workshop is to communicate to industry the logistics
of ECG waveform review as a part of the application review process.
The ECG Warehouse, an annotated Electrocardiogram waveform data (aECG)
storage and review system, is being incorporated into the FDA’s set
of tools. This workshop will inform industry how to make aECG
source data available to reviewers through the ECG Warehouse. This
workshop will also overview the types of information the ECG
Warehouse provides reviewers and will give examples of problematic
aECGs already found.
Traditionally,
the Food and Drug Administration (FDA) has received only summary
representations of electrocardiogram data for the analysis of safety
and efficacy of products. The FDA is interested in improving the
evaluation of specific drug-induced cardiac toxicity by evaluating
ECG waveform data with detailed, sponsor-generated annotations from
the full spectrum of ECG devices including 12-lead standard ECG,
Holter monitors, and implanted devices.
The FDA entered
into a Cooperative Research and Development Agreement with Mortara
Instrument, Inc. to develop a data warehouse application and viewing
tool for aECG in the format specified in the Health Level Seven
standard accredited by the American National Standards Institute. A
web-based system supports communication with the sponsor for
uploading, receipt, validation, transformation, and warehousing of
aECG source data. The warehouse enables the FDA to evaluate aECG
source data for evidence of cardiac toxicity and the viewing tool
allows reviewers to selectively display waveforms and annotations.
FDA is holding
a public meeting to communicate the availability of the ECG
Warehouse for FDA reviewers and the need for industry to upload
aECGs into it. The agenda for this meeting, which will include an
overview of the software capabilities and examples of problematic
aECGs, will be available on the Internet at
http://www.fda.gov/cder/regulatory/ersr/default.htm before the
meeting.
Registration and
Information:
There is no registration fee for this meeting, but pre-registration
is required because of limited seating.
Due to space limitations, only the first 130 registrants and
two individuals per organization will be permitted to attend
this workshop.
To register, please submit your first and last name and the name of
your organization to Lonnie Smith,
smithlo@cder.fda.gov
There will be
no onsite registration.
Questions:
Attendees may
submit questions in advance, regarding the ECG Warehouse system and
the FDA’s use of it during application review. Written submissions
may be made to the contact person by
September 20, 2005.
For Further
Information contact:
Technical
information: Mr.
Devi Kozeli, 301-594-5364
Registration
information: Mr.
Lonnie Smith,
smithlo@cder.fda.gov
Parking
The location of
the meeting is 5630 Fishers Lane, Rockville, MD (next to the
Parklawn Bldg). Registrants should use the lower entrance, which
faces Parklawn Drive. Public parking is not available at the 5630
Fishers Lane location. A public parking lot (for a fee) is available
on Fishers Lane across from the Parklawn Bldg. Additional public
parking (for a fee) is available at the Twinbrook Metro Station,
which is located several blocks west of the meeting location.
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Date created: September 13, 2005 |