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Friday
, November 6
9:00am EST
Chairperson’s Opening Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
9:10am EST
Enabling Globally Compliant Remote Site Access for Monitoring and Source Verification
Blake Adams • Ty Quinn
9:45am EST
Get Ready for ICH E6 R3!
Betsy Fallen
10:20am EST
Discussion on Archiving Timelines
Jamie Marie Toth, CPM, MS • Angel Ramos, Jr., CRM, IGP, MLIS • Hobson Lopes • Russell Joyce • Ralph Feaga
11:05am EST
Networking Break
11:35am EST
TMF: The Sponsor’s Achilles Heel during a Regulatory Inspection
Dr. Andrew Bentley
12:10pm EST
The Role of eTMF in Unified eClinical Technology
Kathie Clark
12:45pm EST
Proper oversight of TMF for validations, system upgrades, audit trail reviews, and systems support
Barbara A. Novak, BS MT(ASCP) • Jamie Marie Toth, CPM, MS • Karen Roy • Rebecca Halbur, A.L.M. • Supriya Shoroff, MS
1:30pm EST
Chairperson's Closing Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
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Global TMF Summit
America/New York
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