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Session 6 Track 3: Trial Master File Reference Model - Preview of Version 3.0 - YOU HEARD IT FIRST!
Session Chair(s)
Maryanne Quinn
President
Integrated Submission Strategies LLC, United States
This session will provide details on the migration to V 3.0 of the TMF RM, including an overview of the process, the participants, the deliverables, and the outreach initiatives. The session will also discuss the physical and technical changes of V 3.0 of the TMF RM and how those changes will affect adopters of the RM, and will facilitate navigation. We will also have an industry case study detailing how the company’s TMF was mapped to the TMF RM and their plans for adoption of V 3.0.
Speaker(s)
Empowering Volunteers to Significantly Impact our Industry - Moving to Version 3 of the TMF Reference Model
Karen Roy, MPHARM
Phlexglobal, United Kingdom
Chief Strategy Officer
Speaker
Todd Tullis
Veeva, United States
Product Manager
Case Study #1: Adpotion and Implementation of the TMF RM - The Journey from V1 to V3
Wendy Trimboli
Eisai Product Creation Systems (EPCS), United States
Associate Director, TMF Process Management & Quality Control, GRA
Case Study #2: Creating a TMF RM Mindset
Donna Dorozinsky, BSN, MSN
Just in Time GCP, United States
President & CEO