2022 Fierce European TMF Summit Presentations

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

Monday, 14 November 2022 

• Workshop A: How the TMF Professional can “Win Friends and Influence People” to Manage their TMF Content
  • Lisa Mulcahy, B.S., Owner, Principal Consultant, Mulcahy Consulting, LLC

• Workshop B: TMF Quality Control: Develop a Risk-Based Approach to TMF Management and Oversight
  • Sarah Curno, Contract Clinical Trial and TMF Specialist, Hedian Records Management

• Workshop D: Alignment in the TMF Process When Working with Partners
  • Gillian Gittens, Director, e-Clinical Strategy & Solutions, TransPerfect Life Sciences
  • Laurel-Ann Schrader, Director, Client Solutions, TransPerfect Life Sciences

Tuesday, 15 November 2022

• What Changes in ICH E6 R3 Can Be Anticipated in Relation to Impact on Clinical Trial Essential Documents and Trial Master Files and Why?
  • Andrew Fisher, MS, Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

• Considerations for a Global TMF
  • Gillian Gittens, Director, e-Clinical Strategy & Solutions, TransPerfect Life Sciences
  • Laurel-Ann Schrader, Director, Client Solutions, TransPerfect Life Sciences

• Explore Strategies for Maintaining a Contemporaneous TMF
  • Chris Jones, Head, Clinical Document Management Business Operations, Novartis

• How Can TMF Management Impact Overall Trial Quality?
  • Eldin Rammell, Head of Quality Assurance, Phlexglobal
  • Rob Jones, Director Professional Services, Phlexglobal

• From File Cabinet to a Process Hub: The Remarkable Journey of the eTMF
  • Ken Lownie, General Manager US Operations, Agatha Inc.

• A Look Beyond Document Management: How to Build a Strong TMF Performance Culture?
  • Astrid Beriaux, Director Clinical Documentation, GSK

• Interactive Discussion: How the TMF Adds Value to Functional Areas
  • Meredith Lafond-Phésans, Global TMF Expert and IQC Manager, Sanofi, Vaccines Business Unit
  • Ranee DiCarlo, Manager, Clinical Records, Gilead Sciences

Wednesday, 16 November 2022

• The Ripple Effect of SaaS eTMF Upgrades: Strategies for Efficient Validation
  • Darshan Patel, Associate Director, Customer Success, eTMF, IQVIA Technologies

• The Harmonization of Clinical Research Information Standards: What Will the Future of the TMF Look Like? Presented by the TMF Reference Model and CDISC
  • Lisa Mulcahy, B.S., Owner, Principal Consultant, Mulcahy Consulting, LLC
  • Rhonda Facile, MS, Vice President, Partnerships and Development, CDISC
  • Joanne Malia, Director, Development Records Management, Regeneron Pharmaceuticals, Inc.
  • Kathie Clark, Product Director, CTMS and eTMF, Ennov
  • Karen Roy, Senior Vice President of Clinical Marketing, Phlexglobal

• Streamlining your eTMF: 10 Good Practices for Reducing Both Effort and Risk
  • Kathie Clark, Product Director, CTMS and eTMF, Ennov

• Incorporate Milestones and Expect Document Lists (EDLs) into Your TMF Practice
  • Soraya Nossoughi, Manager, TMF, Development Records Management (DRM), DO&PM, Regeneron

• Transform Your TMF into an Active Study Management Tool
  • Vittoria Sparacio, Global Head Clinical Document Governance & Management (CDGM), Novartis