Electronic Reporting of Adverse Event Data to the Food and Drug Administration: The Experiences of Glaxo Wellcome And Ze
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0092-8615199 Copyright 0 1999 Drug Information Association Inc.
ELECTRONIC REPORTING OF ADVERSE EVENT DATA TO THE FOOD AND DRUG ADMINISTRATION: THE EXPERIENCES OF GLAXO WELLCOME AND ZENECA AS PARTICIPANTS IN THE ADVERSE EVENT REPORTING SYSTEM PILOT PROJECT MARKBLAKE,MS Manager, Drug Safety and Data Systems, Zeneca Pharmaceuticals, Inc., Wilmington. Delaware
VLASTAPINKSTON, BS Director, North American Product Surveillance, Glaxo Wellcome Inc., Research Triangle Park, North Carolina
The Food and Drug Administration (FDA) has recently initiated a pilot project for electronically submitting individual case safety reports of postmarketed drugs to the agency for upload into the Adverse Event Reporting System (AERS). The data elements and the jile structure used in the submission process are those defined by the E2b and M2 Expert Working Groups. Two drug manufacturers. Glmo Wellcome and Zeneca, have chosen to participate in the pilot. This article presents the experiences of the pilot participants including: the scope and goals of the pilot project, resources required to successfully submit data electronically, lessons learned from participation, and the steps required by industry to fully implement an electronic environment. Key Words: AERS Pilot Project; ICH; SGML; E2b Expert Working Group; M2 Expert Working Group
INTRODUCTION IN NOVEMBER OF 1997, the FDA replaced its postmarketing drug safety data management system with the Adverse Event Reporting System (AERS). AERS was developed in accordance with International Conference on Harmonization (ICH) initiatives and takes advantage of the global standards set by the M1 Medical Terminology, M2 Electronic
Reprint address: Mark Blake, MS, Manager, Drug Safety and Data Systems. Zeneca Pharmaceuticals, Inc., PO Box 15437, Wilmington, DE 19850-5437.
Standards for the Transmission of Regulatory Information (ESTRI), and E2b (Data Elements for Individual Case Safety Reports) Expert Working Groups (1). AERS will allow FDA to quickly process data sent by manufacturers, evaluate safety issues in a timely manner, measure reporting compliance, and monitor the quality of data submitted to the agency (2). AERS also allows manufacturers to electronically submit data for individual case safety reprts to the FDA. These data are extracted from company proprietary databases and written to a data file format using
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Mark Blake and Vlasta Pinkston
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the standard data elements structure defined by the E2b Expert Working Group and electronic file developed by the M2 Expert Working Group. These data can then be submitted to the FDA via physical media and, ultimately, via the Internet. In order to evaluate the procedures and systems required to send data electronically to the agency, a joint FDAPharmaceutical Research and Manufacturers of America (PhRMA) Electronic ADR Task Force was formed in April 1996. The Task Force consisted of 10 industry representatives and members from FDA's Center for Drug Evaluation a
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