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Friday, November 6 • 12:45pm - 1:30pm
Proper oversight of TMF for validations, system upgrades, audit trail reviews, and systems support

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  • Review your Data Integrity Checklist: Where to start and how to finish
  • Discuss guides on Data Integrity and review key Principles of Data Integrity
  • Dive into Audit Trial Reviews: quality system approach to implementing oversight and review, validation, system upgrade, and audit trail reviews
  • System security and protection: cybersecurity trends, detection & response, and security checkpoints

Moderators
avatar for Barbara A. Novak, BS MT(ASCP)

Barbara A. Novak, BS MT(ASCP)

Systems and Process Management Lead Clinical Operations - NA/EU, Kyowa Kirin Pharmaceutical Development, Inc.

Speakers
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 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 →
avatar for Rebecca Halbur, A.L.M.

Rebecca Halbur, A.L.M.

Assoc. Director, Trial Master File (TMF) Systems, Biogen
Rebecca Halbur is the eTMF business system owner at Biogen. Her 11 years of experience in TMF spans document processing, people management, and system oversight in both CRO and biotech where she helped sponsors setup and navigate the TMF environment, assisted with implementing & migrating... Read More →
avatar for Supriya Shoroff, MS

Supriya Shoroff, MS

Associate Director - TMF, Clinical Operations, AMAG Pharmaceuticals, Inc.
Supriya Shoroff is an Associate Director, heading the TMF operations at AMAG Pharmaceuticals in Boston, MA. She has over 12+ years of experience in the R&D, pharmaceutical Industry and has supported/led multiple agency Inspections. She has Implemented several eTMF systems, designed... Read More →


Friday November 6, 2020 12:45pm - 1:30pm EST