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For Industry
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Agenda for the Prescription Drug User Fee Act Information Technology Strategic Planning: Public Meeting Oct. 19, 2007
| 7:30-8:45 am | Registration |
| 9:00 am | Welcome Margo Burnette, FDA Moderator |
| 9:10 – 9:30 am | Strategic Management Malcolm Bertoni, M.S., Director, Planning Staff, FDA Office of Planning |
| 9:30 – 9:50 am | Information Management Timothy Stitely, Chief Information Officer, FDA |
| 9:50 – 10:10 am | PDUFA IV: Information Technology Goals Mark Gray, PDUFA IT Program Director, FDA Office of the Chief Information Officer |
| 10:10 – 10:30 am | Break |
| 10:30 – 11:00 am | Liquent, a Thomson Scientific business |
| 11:00 – 11:30 am | BIO PhRMA |
| 11:30 – 12:00 pm | SAFE-BioPharma Association |
| 12:00- 1:00 pm | Lunch |
| 1:00 – 1:30 pm | Clinical Data Interchange Standards Consortium (CDISC) |
| 1:30 – 2:00 pm | Octagon Research |
| 2:00 – 2:30 pm | GE Healthcare |
| 2:30 – 3:00 pm | General Public Comments |
| 3:00 pm | Adjourn Meeting Margo Burnette, FDA Moderator |
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