Information Technology Strategic Planning Public Meeting
Agenda and Presentations
The purpose of this public meeting, held October 19, 2007, was to provide stakeholders the opportunity to address specific topics and present their views as FDA prepares the PDUFA IT Plan that will be released for public comment by December 31, 2007. The meeting format included presentations by FDA and various stakeholders.
Agenda (36 KB PDF) | text version
Transcript of meeting
Presentations
- FDA presentations
Margo Burnette, FDA Moderator
Malcolm Bertoni, M.S., Director, Planning Staff, FDA Office of Planning
Timothy Stitely, Chief Information Officer, FDA
Mark Gray, PDUFA IT Program Director, FDA Office of the Chief Information Officer
- Liquent, a Thompson Scientific business
Jim Nichols, Vice President of Product Strategy
- BIO PhRMA
PhRMA ERS and BIO IT Working Groups
Rachel Carle, Allen Jones, Steve Ward
- SAFE-BioPharma Association
Cindy Cullen, Chief Technology Officer
- Clinical Data Interchange Standards Consortium (CDISC)
Edward Helton, PhD, Chair elect CDISC BOD
Frank Newby, COO, CDISC
- Octagon Research Solutions, Inc.
Nancy Smerkanich, Vice President, Regulatory Affairs
David Evans, Chief Information Officer
- GE Healthcare
Mark Dente, MD
