Electronic Regulatory Submissions and Review (ERSR): 2003 Annual DIA Meeting Presentations

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

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Electronic Regulatory Submissions and Review (ERSR)
2003 Annual DIA Meeting Presentations

Regulated Clinical Research Information Management: Progress in Standards Development, Randy Levin, M.D.
Creating Documents and eCTD Specifications, Randy Levin, M.D.
DailyMed Initiative: Update - Enhancing Patient Safety Through Accessible Medication Information, Randy Levin, M.D.
HL7 XML Standards and FDA, Randy Levin, M.D.
Processing and Reviewing Electronic Submissions in CDER, Randy Levin, M.D.
FDA Standards Initiatives: An Overview, Randy Levin, M.D.
Processing and Reviewing Electronic Submissions in CDER:
- Review of Electronic Data, Armando Oliva, M.D.
- eCTD Processing, Gary M Gensinger, MBA
- eCTD and the eNDA

Date created: July 15, 2003



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