Improve Your TMF Quality


  November 2–6, 2020    Virtual Event

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Innovative Strategies and Emerging Technologies That Can Impact Your TMF

Clinical trials have been exceedingly different this year, especially around TMF. As a TMF professional, you understand the impact that new technologies, regulations, processes, and partnerships have had on the pharmaceutical industry. Now more than ever, and with updated guidance as a result of COVID-19, sharing knowledge and use cases on how organizations are continuing to handle these changes with updated SOPs, safety-vigilance systems, remote inspections, and more through the digitalization of the TMF is essential.

With a strong focus on how to manage, process, and enhance your TMF, this year's Global TMF Summit will continue to provide strategies, tools, and methods to meet your TMF needs and challenges.

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The #TMFSummit Virtual Experience

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Expert Sessions

Ask questions, read speaker bios, chat; no one will shush you.
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Break-out Discussions

Participate over video in deep dive discussions with your peers during mini breakout sessions.
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Resource Center

Binge watch multimedia content direct from the exhibitors.
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Exhibit Hall

Meet exhibitors 1 on 1 over video to review case studies, explore offerings. Ask all the questions!
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Always On

Power went out? Had to walk the dog? Watch it again anytime for up to 6 months.

Meet the 2020 Advisory Board Members

Astrid Beriaux, Head Trial Master File (TMF), GSK

Astrid Beriaux
Head Trial Master File (TMF)

Priya Chaturvedi, VP, Clinical Quality Assurance, Eisai

Priya Chaturvedi
VP, Clinical Quality Assurance

Kathie Clark, Product Director, CTMS and eTMF, Ennov

Kathie Clark
Product Director, CTMS and eTMF

Grace Crawford, Global Head, Clinical Quality & Compliance, AstraZeneca

Grace Crawford
Global Head, Clinical Quality & Compliance

Donna Dorozinsky, President & CEO, Just in Time GCP

Donna Dorozinsky
Just in Time GCP
President & CEO

Sholeh Ehdaivand, Founder and CEO, LMK Clinical Research Consulting

Sholeh Ehdaivand
LMK Clinical Research Consulting
Founder and CEO

Tim Galvin, Director of Product Management, Medidata

Tim Galvin
Director of Product Management

Lucy Hampshire, Senior Director, Medicines Quality, Eli Lilly and Company

Lucy Hampshire
Eli Lilly and Company
Senior Director, Medicines Quality

Wendy Koc, Associate Director R&D Quality & Compliance, Gilead

Wendy Koc
Associate Director R&D Quality & Compliance

Tim Kroboth, Associate Director, Content Management, IQVIA

Tim Kroboth
Associate Director, Content Management

Christa Lewiski, Study File Manager (TMF Head), Seqirus

Christa Lewiski
Study File Manager (TMF Head)

Joanne Malia, Director, Clinical Documentation Management, Regeneron Pharmaceuticals, Inc.

Joanne Malia
Regeneron Pharmaceuticals, Inc.
Director, Clinical Documentation Management

Barbara Novak, Systems and Process Management Lead, Clinical Operations, Kyowa Kirin, Inc.

Barbara Novak
Kyowa Kirin, Inc.
Systems and Process Management Lead, Clinical Operations

Marie-Christine Poisson-Carvajal, Head of TMF & Registry, Pfizer

Marie-Christine Poisson-Carvajal
Head of TMF & Registry

Lori Ridge, Senior Trial Master File Project Manager, Global Clinical Operations, Mylan

Lori Ridge
Senior Trial Master File Project Manager, Global Clinical Operations

Emily Roberts-Thomson, Vice President of Clinical Operations, Treadwell Therapeutics, Inc

Emily Roberts-Thomson
Treadwell Therapeutics, Inc
Vice President of Clinical Operations

Karen Roy, Chief Strategy Officer, Phlexglobal

Karen Roy
Chief Strategy Officer

Pawel Rucki, Senior Manager, TMF Operations, GW Pharmaceuticals plc

Pawel Rucki
GW Pharmaceuticals plc
Senior Manager, TMF Operations

Vittoria Sparacio, Senior Director & Head, Clinical Documentation Operations, GSK

Vittoria Sparacio
Senior Director & Head, Clinical Documentation Operations

Jamie Marie Toth, CPM, MS, Director, Head of TMF Operations, Clinical Development Operations, Daiichi Sankyo, Inc.

Jamie Marie Toth, CPM, MS
Daiichi Sankyo, Inc.
Director, Head of TMF Operations

Stephanie Viscomi, Associate Director, TMF Operations, Alexion Pharmaceuticals, Inc.

Stephanie Viscomi
Alexion Pharmaceuticals, Inc.
Associate Director, TMF Operations

Courtney Wells, Vice President Clinical Operations, Avadel Pharmaceuticals

Courtney Wells
Avadel Pharmaceuticals
Vice President Clinical Operations

“Talks were superbly presented and highly informative. There was a great sense of Connectivity at the event, with lots of ideas and collaboration.”

Clinical Trial Administrator, DIURNAL, LTD

“Great presenters and speakers who discussed some of the regulatory challenges of document management.”


Sponsoring Organizations

Strategic Partners