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Compliance and Regulatory Updates
Innovations
Partnerships
Quality Management
TMF Health
Zoom Roundtable
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JW
James Wallace
LivaNova USA, Inc.
Sr. Specialist, Clinical QA
Monday
, November 2
9:00am EST
Chairperson’s Opening Remarks
Jamie 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 Operations
Marie-Christine Poisson-Carvajal
12:50pm EST
Leverage Reports and Dashboards to Assess TMF health
Kent Johnson
Tuesday
, November 3
9:00am EST
Chairperson’s Opening Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
9:10am EST
Key Document Reviews- A Risk Based Approach to TMF QC
Anusha Rameshbabu • Stephanie Viscomi
10:20am EST
Ownership of the TMF as a Central Repository
Barbara Hepworth-Jones • Christa Lewiski • Priya Chaturvedi, PhD. • Katrien Clinckx
11:35am EST
The Full Story – TMF Completeness
Fiona MacKenzie
12:45pm EST
Your trial is done; now what? Quality Management in TMF Archiving
Courtney Wells • Eldin Rammell • Mallorie Sayre • Krista Serratore
Wednesday
, November 4
9:00am EST
Chairperson's Opening Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
10:20am EST
Solving the Email Problem: Automating Correspondence Classification in the TMF
Daniel Koppers • Marisa Minetti
11:20am EST
TMF in the Virtual Inspection Reality
Liz Farrell
11:55am EST
Simplifying and Ensuring Compliance with a Unified, Automated eTMF
Tim Galvin
Thursday
, November 5
9:00am EST
Chairperson’s Opening Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
10:20am EST
Discuss CRO, Sponsor, and Site Collaboration and Best Practices
Vittoria Sparacio • Stephanie Mayew • Joanne Malia • Leanne Rice • Pawel Rucki
11:35am EST
Deep Dive into CRO Oversight through TMF
Donatella Ballerini
12:45pm EST
Managing the Exchange of Documents Between Sponsor eTMF and (e)ISF
Dr. 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 Access
Blake Adams
Friday
, November 6
9:00am EST
Chairperson’s Opening Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
10:20am EST
Discussion on Archiving Timelines
Jamie Marie Toth, CPM, MS • Angel Ramos, Jr., CRM, IGP, MLIS • Hobson Lopes • Russell Joyce • Ralph Feaga
11:35am EST
TMF: The Sponsor’s Achilles Heel during a Regulatory Inspection
Dr. Andrew Bentley
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
Timezone
Global TMF Summit
America/New York
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Global TMF Summit
Nov 2
-
6, 2020
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, November 2
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, November 3
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, November 4
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, November 5
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, November 6
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