Global TMF Summit has ended

Create Your Own Event

Global TMF Summit

JW

James Wallace

LivaNova USA, Inc.
Sr. Specialist, Clinical QA

9:00am EST

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

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

11:40am EST

Inspection Best Practices for TMF OperationsMarie-Christine Poisson-Carvajal

12:50pm EST

Leverage Reports and Dashboards to Assess TMF healthKent Johnson

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

10:20am EST

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

11:35am EST

The Full Story – TMF CompletenessFiona MacKenzie

12:45pm EST

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

9:00am EST

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

10:20am EST

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

11:20am EST

TMF in the Virtual Inspection RealityLiz Farrell

11:55am EST

Simplifying and Ensuring Compliance with a Unified, Automated eTMFTim Galvin

9:00am EST

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

10:20am EST

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

11:35am EST

Deep Dive into CRO Oversight through TMFDonatella Ballerini

12:45pm EST

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

1:45pm EST

Zoom Rountable: How to Avoid Remote Monitoring Failure: A Site First Strategy for Remote AccessBlake Adams

9:00am EST

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

10:20am EST

Discussion on Archiving TimelinesJamie Marie Toth, CPM, MS • Angel Ramos, Jr., CRM, IGP, MLIS • Hobson Lopes • Russell Joyce • Ralph Feaga

11:35am EST

TMF: The Sponsor’s Achilles Heel during a Regulatory InspectionDr. Andrew Bentley

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