Connecting Leaders to
Advance Strategic TMF
2023 Agenda
Review last year’s sessions before 2024 speakers are announced.
Wednesday, April 26
Thursday, April 27
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
Senior Director, GCP Operational Excellence
Head, Process, Training, and Digital Solutions
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
Director, TMF Operations
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)
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
Director, TMF Operations and Records Management
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
Director, Development Records Management
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)
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
Director, Innovation & Business Strategy