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Connecting Leaders to
Advance Strategic TMF

April 18, 2024 | The Warwick Hotel Rittenhouse Square Philadelphia

2023 Agenda

Review last year’s sessions before 2024 speakers are announced.

Wednesday, April 26

6:00 p.m. – 9:00 p.m.
6:00 p.m.
Welcome Networking Reception

Thursday, April 27

7:30 a.m. — 5:00 p.m.
7:30 a.m.
Breakfast
9:00 a.m.
Opening Keynote

Takeda: Building the Foundation for R&D Transformation with eTMF

In the opening keynote, Takeda shares how their R&D “Future Fit” transformation program accelerates trial delivery without compromising quality. Learn how they leverage eTMF as a foundational application to connect clinical systems, improve access to documentation and operational data, and drive compliance.
Location: Lafayette South

Lisa Joseph
Lisa Joseph Takeda
Senior Director, GCP Operational Excellence
Melissa Chiasson Takeda
Head, Process, Training, and Digital Solutions
10:00 a.m.
Session

Eisai: Improving Inspection Readiness in an R3 World

Eisai evaluates the impact of ICH E6(R3) on TMF operations. You’ll hear what programs they’re implementing to improve inspection readiness and increase oversight, as well as get an action plan to drive TMF compliance at your own organization.
Location: Lafayette South

Supriya Shoroff
Supriya Shoroff Eisai
Director, TMF Operations
11:00 a.m.
Facilitated Networking

Connect: Assessing Regulatory Changes and their Impact on TMF

New regulations and industry guidance will impact TMF operations. Join this collaborative discussion to get a regulatory overview — including the most recent EMA findings — and develop strategies to ensure TMF compliance.
Location: Girard (Connect A)

Workshop: Driving Solutions to Optimize TMF Management

In an interactive workshop, evaluate TMF challenges and collaborate with your peers to draft plans to address them. You'll examine ways to improve site document exchange, operationalize artificial intelligence, and enhance document processing models.
Location: Lafayette North (Connect B)

12:00 p.m.
Lunch
1:00 p.m.
Session

Daiichi Sankyo: Automating for TMF Completeness and Agility

Daiichi Sankyo shares strategies for their planned “Year to Revolutionize TMF.” This includes automating processes and better leveraging data across systems to improve TMF completeness, and increase agility amid rapid company growth.
Location: Lafayette South

Laura Naranjo Daiichi Sankyo
Director, TMF Operations and Records Management
2:00 p.m.
Session

Regeneron: Improving TMF Metrics with CRO Partners

Regeneron details how they drive CRO collaboration and oversight to improve key TMF health measurements. Learn how they identify and address bottlenecks that impede TMF timeliness.
Location: Lafayette South

Joanne Malia
Joanne Malia Regeneron Pharmaceuticals
Director, Development Records Management
3:00 p.m.
Facilitated Networking

Connect: Preparing for Emerging TMF Trends

Organizations continue to adopt risk-based and quality-by-design approaches to TMF, in line with regulatory expectations. Join a collaborative discussion with fellow large pharmas or small biopharmas to learn about this and other emerging trends in TMF and get actionable steps to prepare for these changes.
Location: Girard (Connect A) and Lafayette North (Connect B)

4:00 p.m.
Session and Close

AstraZeneca: Developing a Digital TMF Strategy

AstraZeneca shares how their eTMF innovations drive efficiencies from study start-up to archival. Learn how to identify and implement new programs to improve document processes and become a more data-driven organization.
Location: Lafayette South

Sara Kraft
Sara Kraft AstraZeneca
Director, Innovation & Business Strategy

Connect with TMF Leaders

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