Drug Information Association
In Cooperation with the U.S. Food and Drug Administration and PhRMA
Guidance for Industry: Regulatory Submissions in Electronic Format
September 25, 1997
Bethesda Marriott Hotel, Bethesda, MD, USA

The Electronic Records; Electronic Signatures Regulation [21 CFR Part 11], effective August 20, 1997, permits the submission of regulatory documents in electronic format without accompanying paper for those submissions that the Agency has announced that they are prepared to accept. In September 1997, CDER expects to have guidance and mechanisms in place to accept for archive in electronic format case report forms (CRFs) and case report tabulations (CRTs). Electronic submission of other document types will follow.

The Guidance for Industry Regulatory Submissions for Archive in Electronic Format provides the specifications for the file formats that CDER is prepared to accept for archiving. This workshop is intended to help industry personnel prepare electronic documents as described by the guidance document and provide a forum to ask questions and receive feedback. At this workshop, CDER representatives from the Office of Information Technology and the Electronic Submissions Technical Working Group will provide a step-by-step overview of the guidance document, present examples of submissions and describe CDER's procedures for processing electronic documents. They will answer technical questions on the preparation and submission to CDER of regulatory submissions in electronic format.

Title	Speaker	Affiliation
Electronic Document Room Conformance Checklist (Posted 11/7/97)	Greg Warzala	FDA/CDER Office of Information Technology Data Management Services
Industry Perspective	Krishan K. Arora Ph.D.	Novartis Pharmaceutical Corp. Electronic Regulatory Submissions, Drug Regulatory Affairs
Organization of the Guidance Document	David C. Isom	FDA/CDER Office of Information Technology
PDF for Document Formats	Gregory Brolund	FDA/CDER Office of Information Technology
Submitting Archival Files	Gregory Warzala	FDA/CDER Office of Information Technology Data Management Services

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Last update: July 11, 2005

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