September 13, 2005
Text below is mirror of posting from www.fda.gov site.
Date: Friday, September 30, 2005
Time: 9:30 a.m. – 11:30 a.m.
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, firstname.lastname@example.org
There will be no onsite registration.
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:
Mr. Devi Kozeli, 301-594-5364
Mr. Lonnie Smith, email@example.com
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.