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Global TMF Summit

Daniele Dedominici

PSI CRO
Records Specialist
Savigliano

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Experience in archives and records management; projects completed for archives re-arrangement, disposal implementation and classification scheme review. Good knowledge of international standards (e.g. ISO 15489, ISAD(G),ISAAR(CPF), EAD,EAC,PREMIS ) and best practices. Good Knowledge of GCP guidelines, ICH and FDA regulation, TMF reference model (DIA) and ALCOA+ standard.

My Friends

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

9:10am EST

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

11:35am EST

The Full Story – TMF CompletenessFiona MacKenzie

12:10pm EST

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

9:45am EST

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

11:55am EST

Simplifying and Ensuring Compliance with a Unified, Automated eTMFTim Galvin

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

11:35am 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

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

11:35am 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