Trial Master File Summit 2021: Full Schedule

1:30pm CDT

Improve TMF Quality Through Metrics

Speakers

Daniel Bennett

Trial Master File Manager, Shionogi Europe

Daniel has worked in various TMF roles for large pharma companies and small biotech, with a full-service CRO and a niche TMF provider. Having seen the issues from all sides he is a convert to the idea that the TMF is a key part of a quality approach to clinical trial management. He... Read More →

Tuesday October 26, 2021 1:30pm - 2:00pm CDT

TMF Strategy - Live Streamed to Virtual Audience

12:15pm CDT

Panel: Use a Data Driven eTMF to Improve Quality, Timeliness, and Completeness, With Contributors

Moderators

Suliat Oyelami-Davies

Associate Director, Clinical Operations Inspection Readiness, Eidos Therapeutics, a Bridge Bio Company

Speakers

Gabrielle Gauger

Program Manager, TMF Operations, Syneos Health

Joanne Malia

Director, Clinical Documentation Management, Regeneron

Joanne Malia is Director, Clinical Documentation Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF. Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech... Read More →

Leila Ponce

Sr Manager, Clinical Systems & Records Management, Seagen

Wednesday October 27, 2021 12:15pm - 1:00pm CDT

TMF Strategy - Live Streamed to Virtual Audience

2:30pm CDT

Optimizing your TMF Plan

Speakers

Traci Wendler

Sr. Manager, TMF Study Lead Line Head, Bristol-Myers Squibb

Traci has worked in Regulatory & Compliance for the past 16 years, focusing on clinical research trials, specifically the TMF for the last 10 years. Her career history includes working for 2 major pharmaceutical companies, a TMF vendor, the NIH and Stony Brook Research Foundation... Read More →

Wednesday October 27, 2021 2:30pm - 3:00pm CDT

TMF Strategy - Live Streamed to Virtual Audience