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JH
Jamie Han
Gilead Sciences
Clinical Records Associate III
Monday
, November 2
9:00am EST
Chairperson’s Opening Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
9:15am EST
How to Avoid The Meaningless Figures – Considerations for TMF Metrics
Chris Jones
9:50am EST
The Push for Full Content Management within the eTMF System
Laura 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
11:40am EST
Inspection Best Practices for TMF Operations
Marie-Christine Poisson-Carvajal
12:15pm EST
Secrets to a Healthy TMF
LoriAnn M. Verna, RN, BSN
12:50pm EST
Leverage Reports and Dashboards to Assess TMF health
Kent Johnson
1:20pm EST
Chairperson's Closing Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
1:35pm EST
Zoom Rountable: TMF Health
LoriAnn M. Verna, RN, BSN
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
9:45am EST
Signposting: Navigating Sponsor Oversight
Darshan Patel
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
12:10pm EST
Brick by Brick: Building a Successful TMF Operations Department
Noeleen Valenzuela • Sholeh Ehdaivand
12:45pm EST
Your trial is done; now what? Quality Management in TMF Archiving
Courtney Wells • Eldin Rammell • Mallorie Sayre • Krista Serratore
1:30pm EST
Chairperson's Closing Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
1:45pm EST
Zoom Rountable: Building Blocks of TMF Operations
Sholeh Ehdaivand
Wednesday
, November 4
9:00am EST
Chairperson's Opening Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
9:10am EST
Possible Futures for Research
Mick Mullane
9:45am EST
Practical Applications of Machine Learning for Clinical Document and TMF Automation
Jay Smith
10:20am EST
Solving the Email Problem: Automating Correspondence Classification in the TMF
Daniel Koppers • Marisa Minetti
10:50am EST
Networking Break
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
12:30pm EST
Proper Oversight During TMF Migration and How to Switch Between eTMFs
Allison Varjavandi • Ronla Prince • Noeleen Valenzuela • Alison Hussain
1:15pm EST
Chairperson's Closing Remarks
Jamie 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 Climate
Tim Galvin
Zoom Rountable: How Organizations are Collaborating More Effectively to Improve Speed, Quality, Efficiency
Chris McSpiritt
Thursday
, November 5
9:00am EST
Chairperson’s Opening Remarks
Jamie Marie Toth, CPM, MS • Karen Roy • Marie-Christine Poisson-Carvajal • Wendy Beeby
9:10am EST
Challenges in Assessing TMF Completeness without an eTMF system
Ashlyn Deshaies
9:45am EST
Collaborating Effectively to Transform Clinical Trials
Chris McSpiritt
10:20am EST
Discuss CRO, Sponsor, and Site Collaboration and Best Practices
Vittoria Sparacio • Stephanie Mayew • Joanne Malia • Leanne Rice • Pawel Rucki
11:05am EST
Networking Break
11:35am EST
Deep Dive into CRO Oversight through TMF
Donatella Ballerini
12:10pm EST
The Road to TMF Quality: Improve Site Regulatory Oversight
Dylan Loch
12:45pm EST
Managing the Exchange of Documents Between Sponsor eTMF and (e)ISF
Dr. Martina Duevel • Colleen Butler • M. Christine Morris • Etienne Hinton
1:30pm EST
Chairperson's Closing Remarks
Jamie 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 Access
Blake Adams
Zoom Rountable: When TMF Issues Shouldn't be TMF Issues
Dylan Loch
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
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Global TMF Summit
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