Maintaining Computer Systems in a Validated State: A Risk-Based Approach

J. Scott Hodges, Ph.D., Project Manager
Stelex-TVG
Bensalem, PA

Implementing the New Clinical Data Interchange Standards (CDISC)

Gary Walker, Senior Director
Quintiles Transnational
Kansas City, MO

Update on FDA Center E-submissions, Part I

Joseph Montgomery, Technical Head
FDA Gateway Program
U.S. FDA/CBER
Rockville, MD

Update on FDA Center E-submissions, Part II

Robert Gatling, Director, Program Operations Staff
U.S. FDA/CDRH
Rockville, MD

Using IT to Speed Up the Submission Process

Daniel R. Matlis, Vice President
Stelex-TVG
Bensalem, PA

Electronic Signatures: From First Signing to E-Submissions

Ty M. Mew, President
Ofni Systems, Inc.
Raleigh, NC

Applying the Risk-Based Concept to Clinical Trial Data

Lisa Olson, Principal Compliance Consultant
SEC Associates
Research Triangle Park, NC

Keynote Luncheon Address: Impact of FDA's Latest Guidance on Part 11

Martin Browning, President
EduQuest
Hyattstown, MD
(Former Special Assistant to the Associate Commissioner for Regulatory Affairs, U.S. FDA)

Communicating Results of Post-Marketing Commitment Studies


Beth Duvall-Miller, Project Management Office
Office of New Drugs
U.S. FDA/CDER
Rockville, MD

Responding to Inspection Observations

Gordon Richman, Vice President and General Counsel
EduQuest
Hyattstown, MD