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Monday, November 2 • 10:25am - 11:10am
TMF Reference Model: The why, who, how and where to!

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  • A brief history of the TMF RM
  • Overview of version 3.2 (Release November 2020)
  • Open Panel discussion to ask any questions you want to the Steering Committee

Moderators
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal
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 →

Speakers
avatar for Lisa D.  Mulcahy, B.S.

Lisa D. Mulcahy, B.S.

Owner, Principal Consultant, Mulcahy Consulting, LLC
Lisa has 29+ year career in the biopharmaceutical R&D industry, in Clinical Operations, Quality Management, and since 2007 as an independent consultant focusing solely on the TMF management process. She assists clients with improvement of their current state, set up and use of eTMF... Read More →
avatar for Jamie Marie Toth, CPM, MS

Jamie Marie Toth, CPM, MS

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Marie-Christine Poisson-Carvajal

Marie-Christine Poisson-Carvajal

Head of TMF and Registry, Pfizer
Marie-Christine is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities... Read More →
avatar for Wendy Trimboli

Wendy Trimboli

Senior Director Clinical Operations Process, Systems & Inspection Readiness, ACADIA Pharmaceuticals Inc.
Wendy has extensive pharma experience in clinical research and operations with expert knowledge of the end-to-end drug development process and current regulatory authority requirements in a global environment. She has facilitated cross-functional process improvement initiatives utilizing... Read More →


Monday November 2, 2020 10:25am - 11:10am EST