Zdrowie i gospodarka · 22/02/2000

Technical Implementation of Electronic Records and Electronic Signatures; Public Meeting and Request for Presentation Abstracts

The Food and Drug Administration (FDA) is announcing a public meeting on industry's experience in implementing the technical provisions of regulations on electronic records and electronic signatures, and requesting abstracts of presentations persons would like to give at the meeting. FDA and the Parenteral Drug Association (PDA) are co-sponsoring this event. However, participation is not limited to the pharmaceutical industry; all interested persons, from all FDA regulated industries, are invited to participate. The purpose of the meeting is to exchange information on the range of experiences persons subject to these regulations have had in implementing the rule's technical provisions and available products and services that enable implementation of those requirements. This will neither be a forum to discuss the merits of the rule, nor a tutorial on the regulation; meeting attendees should have a basic understanding of these regulations. Information presented at the event will assist FDA in developing future industry guidance documents with respect to these regulations.