2023 Fierce TMF Summit Presentations

Please check back for updates as we confirm permission from the presenters to share their presentations.

March 20

Workshop A: What You Need to Know About TMF Plan Template Version 2.0!

  • Jamie Marie Toth, BeiGene USA
  • Deb Oriez, Sarepta Therapeutics

Workshop B: Trust the Process: An Overview of End-to-End TMF Management

  • Gillian Gittens, TransPerfect Life Sciences
  • Laurel-Ann Schrader, TransPerfect Life Sciences

Workshop C: The Ugly Truth: A Deep Dive into TMF Review

  • Jason King-Andreini, BridgeBio Therapeutics

Workshop D: Reporting & Archiving: The Overlooked Value of Common eTMF Tasks

  • Dario Lirio, ArisGlobal
  • Shannon Kryder, ArisGlobal

March 21

Inspector Spotlight: A Look into an Inspector's Journey Navigating the TMF

  • Craig A. Garmendia, FDA

From Author to Archive: Connecting eClinical Work Streams to Your eTMF

  • Gillian Gittens, TransPerfect Life Sciences
  • Laurel-Ann Schrader, TransPerfect Life Sciences

Utilize Audit Trails to Demonstrate Oversight, Completeness and Accuracy of the TMF

  • Marcin Hernik, Phlexglobal
  • Rob Jones, Phlexglobal

The Transition of the TMF Reference Model to CDISC and to a Standard

  • Karen Roy, CDISC
  • Dawn Niccum, inSeption Group
  • Jamie Matie Toth, BeiGene USA
  • Kathie Clark, Ennov
  • Paul Fenton, Montrium

Bridge System and Business Operational Gaps to Support TMF Excellence

  • Janelle Kowalczyk, AbbVie
  • Stephanie Becks, AbbVie

How to Use Reports and Dashboards to Drive Inspection Readiness

  • Laura Tenbrink, EQRx
  • Christina Gibson, EQRx
  • Mandi Conklin, EQRx

United Front! How Organizations Can Collaborate for an Effective Quality Review Framework for TMF

  • Ramya Iyer, Regeneron

Crowdsource UAT- An Opportunity for Future Validation

  • Darshan Patel, IQVIA

March 22

How Are European Union Clinical Trials Impacting Global TMFs

  • Dr. Martina Duevel, Bayer AG

Standardize Your Organization's TMF by Ironing Out Content and Correspondence, Structure, and Naming Conventions

  • Daniel Bennett, Shionogi Europe

ICH M11 and the Future of the TMF

  • Kathie Clark, Ennov

Establish a Governance Structure with Respect to the TMF Index

  • Jason King-Andreini, BridgeBio Therapeutics