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 to shape the agenda and/or participate as a speaker or panelist, please contact Aimee Gutzler, Conference Production Director, [email protected].

  • 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

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