Electronic Submissions: How to Maximize the Benefits and Try to Minimize the Costs

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Electronic SubmissionsHow to Maximize the
Benefits and Try to Minimize the Costs

• 27 June 2002
• San Diego Regulatory Affairs Network

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Panelists

• Antoinette Azevedo, ModeratorPresident CEO,
  e-SubmissionsSolutions.com
• Chris Patterson, Manager, Regulatory Affairs and
  Electronic SubmissionsCancerVax Corporation
• Daniel Kim, Manager, Regulatory Affairs, IDEC
  Pharmaceuticals Corp. 
• John F. Wood, M.B.A., RAC, Director, Regulatory
  Affairs, Amylin Pharmaceuticals

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Agenda

• Introductory Comments
• eIND demo discussion Chris Patterson
• eBLA demo discussion Daniel Kim
• eNDA demo discussion John F. Wood
• Questions Answers -- All

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Paper vs Electronic Formats

• 350-page volumes
• Tabs/slip sheets separating documents
• Multiple copies of the submission
• Tables of contents
• Highly-ordered organization of content

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Paper vs Electronic Formats

• PDF SAS Transport files
• Delivered on CD-ROM or Tape
• PDF Bookmarks Hyperlinks
• Hyperlinked Tables of Contents
• Reviewed electronically
• Single copy submitted
• Potentially no paper