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Trial Master File Summit 2021
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Tuesday, October 26 • 11:30am - 12:15pm
Panel Discussion: Risk-Based Approach to Periodic Review

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Moderators
avatar for Jason King-Andreini

Jason King-Andreini

Senior Manager, TMF Operations, Eidos Therapeutics, a Bridge Bio Company

Speakers
avatar for Masoom Patel

Masoom Patel

Senior Clinical Document Management Specialist, Takeda
avatar for Traci Wendler

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 →
avatar for Christa Lewiski

Christa Lewiski

Associate Director, Records & Information Management (TMF Head), Akebia Therapeutics
Christa Lewiski is the TMF Head, Associate Director Records Information Management at Akebia Therapeutics, Inc. She is the owner of Akebia's TMF system and also responsible for all TMF processes. Christa has 20 years experience in TMF/clinical document management within the biopharmaceutical... Read More →


Tuesday October 26, 2021 11:30am - 12:15pm CDT