Global TMF Summit has ended

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Global TMF Summit

9:00am EST

Chairperson’s Opening RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby

9:15am EST

How to Avoid The Meaningless Figures – Considerations for TMF MetricsChris Jones

9:50am EST

The Push for Full Content Management within the eTMF SystemLaura Naranjo, M.S.J

10:25am EST

TMF Reference Model: The why, who, how and where to!Karen Roy • Lisa D. Mulcahy, B.S. • Jamie Marie Toth, CPM, MS • Marie-Christine Poisson-Carvajal • Wendy Trimboli

11:10am EST

Networking Break

11:40am EST

Inspection Best Practices for TMF OperationsMarie-Christine Poisson-Carvajal

12:15pm EST

Secrets to a Healthy TMFLoriAnn M. Verna, RN, BSN

12:50pm EST

Leverage Reports and Dashboards to Assess TMF healthKent Johnson

1:20pm EST

Chairperson's Closing RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby

1:35pm EST

Zoom Rountable: TMF HealthLoriAnn M. Verna, RN, BSN

9:00am EST

Chairperson’s Opening RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby

9:10am EST

Key Document Reviews- A Risk Based Approach to TMF QCAnusha Rameshbabu • Stephanie Viscomi

9:45am EST

Signposting: Navigating Sponsor OversightDarshan Patel

10:20am EST

Ownership of the TMF as a Central RepositoryBarbara Hepworth-Jones • Christa Lewiski • Priya Chaturvedi, PhD. • Katrien Clinckx

11:05am EST

Networking Break

11:35am EST

The Full Story – TMF CompletenessFiona MacKenzie

12:10pm EST

Brick by Brick: Building a Successful TMF Operations DepartmentNoeleen Valenzuela • Sholeh Ehdaivand

12:45pm EST

Your trial is done; now what? Quality Management in TMF ArchivingCourtney Wells • Eldin Rammell • Mallorie Sayre • Krista Serratore

1:30pm EST

Chairperson's Closing RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby

1:45pm EST

Zoom Rountable: Building Blocks of TMF OperationsSholeh Ehdaivand

9:00am EST

Chairperson's Opening RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby

9:10am EST

Possible Futures for ResearchMick Mullane

9:45am EST

Practical Applications of Machine Learning for Clinical Document and TMF AutomationJay Smith

10:20am EST

Solving the Email Problem: Automating Correspondence Classification in the TMFDaniel Koppers • Marisa Minetti

10:50am EST

Networking Break

11:20am EST

TMF in the Virtual Inspection RealityLiz Farrell

11:55am EST

Simplifying and Ensuring Compliance with a Unified, Automated eTMFTim Galvin

12:30pm EST

Proper Oversight During TMF Migration and How to Switch Between eTMFsAllison Varjavandi • Ronla Prince • Noeleen Valenzuela • Alison Hussain

1:15pm EST

Chairperson's Closing RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby

1:30pm EST

Zoom Rountable: 2021 and Beyond: Innovations in eTMF in the Current ClimateTim Galvin Zoom Rountable: How Organizations are Collaborating More Effectively to Improve Speed, Quality, EfficiencyChris McSpiritt

9:00am EST

Chairperson’s Opening RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby

9:10am EST

Challenges in Assessing TMF Completeness without an eTMF systemAshlyn Deshaies

9:45am EST

Collaborating Effectively to Transform Clinical TrialsChris McSpiritt

10:20am EST

Discuss CRO, Sponsor, and Site Collaboration and Best PracticesVittoria Sparacio • Stephanie Mayew • Joanne Malia • Leanne Rice • Pawel Rucki

11:05am EST

Networking Break

11:35am EST

Deep Dive into CRO Oversight through TMFDonatella Ballerini

12:10pm EST

The Road to TMF Quality: Improve Site Regulatory OversightDylan Loch

12:45pm EST

Managing the Exchange of Documents Between Sponsor eTMF and (e)ISFDr. Martina Duevel • Colleen Butler • M. Christine Morris • Etienne Hinton

1:30pm EST

Chairperson's Closing RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby

1:45pm EST

Zoom Rountable: How to Avoid Remote Monitoring Failure: A Site First Strategy for Remote AccessBlake Adams Zoom Rountable: When TMF Issues Shouldn't be TMF IssuesDylan Loch

9:00am EST

Chairperson’s Opening RemarksJamie 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 VerificationBlake Adams • Ty Quinn

9:45am EST

Get Ready for ICH E6 R3!Betsy Fallen

10:20am EST

Discussion on Archiving TimelinesJamie 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 InspectionDr. Andrew Bentley

12:10pm EST

The Role of eTMF in Unified eClinical TechnologyKathie Clark

12:45pm EST

Proper oversight of TMF for validations, system upgrades, audit trail reviews, and systems supportBarbara 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 RemarksJamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby