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Thursday, June 18 • 5:00pm - 6:00pm
#510 OD: ON DEMAND - Journey of TMF Reference Model in Driving Inspection Readiness: The Decade's Impact, the Evolution to Come

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Component Type: Session
Level: Intermediate

The TMF Reference Model was first released at DIA ten years ago in 2010. This session features a case study on how active eTMF management drives inspection readiness, along with an overview of the TMF Reference Model's ten year history, data from the 2020 TMF survey and details on the model's ongoing evolution.

Learning Objectives

Describe impact to inspection readiness when leveraging the TMF Reference Model; Evaluate the impact of TMF Reference Model evolution.


Fran Ross


TMF Reference Model: The Ten Year Journey
Karen Jane Roy, MPharm

Active TMF Management is Key for Inspection Readiness
Jamie Marie Toth, MS

TMF Reference Model: 2020 Survey and Beyond
David Ives

avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal, United Kingdom
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Jamie Toth

Jamie Toth

Director, Head of TMF Operations, Daiichi Sankyo
Jamie has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo, Inc. since 2016 as the Director/Head of TMF Operations. She is a Steering Committee member of the DIA TMF Reference Model Working Group and on the Operations Committee and a... Read More →
avatar for Fran Ross

Fran Ross

Practice Director, Trial Master File, Advanced Clinical
Fran Ross is Practice Director for Trial Master File Practice at Advanced Clinical, driving the implementation and expansion of our document management solutions and TMF consulting offerings. Fran oversees eTMF optimization projects, including conversions, system deployment, migrations... Read More →

David Ives

Director, Head of TMF Operations, Alexion Pharmaceuticals Inc
Enthusiastically solving regulated information management challenges and defining best in class strategy since 2007. Currently proudly serving as a DIA TMF Reference Model Steering Committee Member

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044