Through research with industry professionals on current trends, areas of interest, and common challenges, we are shaping the agenda for the 10th Trial Master File Summit to ensure the topics selected for sessions reflect the industry’s needs and wants. We appreciate your patience.

If you’d like to be involved in this process and help shape the 2021 agenda and/or participate as a speaker, panelist or roundtable moderator, please contact us here.


2020 Program Highlights Included:

  • Four educational workshops

  • Six themed tracks

  • Detailed case studies and informational sessions featuring lessons learned in TMF operations, partnerships, functional areas, Quality, inspection readiness, and eTMF/technology enhancements

  • 50+ expert speakers from varying sized pharma, CRO, site, and vendor organizations

  • More than 10 dedicated hours of networking with the TMF community

  • Vendor exhibits with representatives to help solve your team’s challenges


2020 Sessions Included:

Understand the Relationship Between TMF Quality and Technology to Improve Inspection Readiness

Karen Freid, Essential Document Specialist, MERCK

Bryan Souder, Director, TMF Head, MERCK


Case Study: Inspection Readiness One Year Later

Dawn Clowes, Manager, Regulatory TMF, BIOGEN

Liz Farrell, Associate Director, TMF, BIOGEN


TMF Quality: Improvement Through Metrics Implementation

Alex Markiel, Director, Clinical Records Management (CRM) and Trial Operations Platforms, Global Development Operations, PHARMACYCLICS


Inspection Experiences: Stories From the Front Line — Case 1: New-Age Inspection Practices Require New Thoughts on Policies and Access

Hobson Lopes, Manager, Clinical Archive, REGENERON PHARMACEUTICALS