Table of Contents Agenda

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Agenda

Electronic Investigational New Drug Application:

Cumulative Table of Contents (CTOC); Public Meeting

January 26, 2001

5630 Fishers Lane, Rockville, Maryland

8:30 – 9:30 am: Registration and Check-in

9:30 – 9:35 am: Opening Remarks

9:35 – 9:55 am: Life Cycle Management

9:55 – 10:15 am: The Role of the Table of Contents in the IND Review

10:15 – 10:35 am: Using XML

10:35 – 11:00 am: CTOC Beta Model Demonstration
                                        Reviewer’s View of Pilot CTOC
                                        Sponsor’s View of Pilot CTOC
                                        Navigation and Sorting Tools

11:00 – 11:30 am: CTOC Files
                                       6 CTOC Files
                                        Paper Replacement Files (PDF)
                                        Organization of Files and Folder(s)

11:30 – 12:00 noon: Author Tool and Validator

12:00 – 1:30 pm: Lunch (on your own)

1:30 – 3:30 pm: Panel Discussion for the Following Points

Would a cumulative table of contents offer you advantages?

How difficult is it for you to create and maintain the XML files needed for the cumulative table of contents?

How difficult will it be for you to incorporate the preparation of an XML document in your submission preparation process?

Do you have suggestions for improvements on the cumulative table of contents?

Are you interested in piloting the cumulative table of contents in electronic IND's with the agency?

Are you interested in working with us to develop tools to be used with the cumulative table of contents?

Do you have other comments or suggestions?

3:30 – 3:50: Next Steps

3:50 – 4:00: Closing Comments

FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DLIS
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