Agenda
Tuesday, April 1
Wednesday, April 2
Pfizer: Changing TMF Operating Models for Simplicity and Connectivity
Pfizer shares how a new TMF operating model will enable simplicity and improve connectivity across the business and with sites. This includes practical tips for change management and examples of key processes to simplify.

TMF Operations Lead, Director
Emerging Biotech: Strengthening CRO Partnerships for TMF Quality and Efficiency
Apellis’ head of TMF shares lessons learned from current and former companies, including how to build an operating model on strong CRO partnerships and align processes and metrics for TMF teams of all sizes.

Director, Clinical Documentation & TMF
Discussion: Understanding the CDISC TMF Reference Model Revision and Roadmap
CDISC shares how organizations can prepare for the latest revision of the TMF Reference Model, which aims to standardize and digitize the historical model. Discuss key takeaways from the revision, steps to prepare your organization, and what’s next on CDISC’s roadmap.

Chair of TMF Reference Model Working Group and TMF Standards Subgroup, Member of TMF Reference Model Steering Committee

Incoming Chair-Elect of the TMF Reference Model Working Group, Member of TMF Reference Model Steering Committee

Vice President, Clinical Operations Strategy
Discussion: Strategies to Improve Site Collaboration (Repeat Session)
More than 70% of total documents by volume in the TMF come from sites. Discuss strategies to improve site collaboration and TMF planning.

Director, Clinical Operations Strategy

Manager, Customer Success, Clinical Operations
AbbVie: Driving Organizational Change with Strategic Partnerships
AbbVie shares the importance of TMF in leading organizational change. This includes how collaboration with study teams and sites and task distribution improve accuracy and completeness.

Director, Clinical Records Management
Discussion: How Technology Can Help Make Data-Driven Decisions
Discuss with peers how to use technology to identify actionable insights from your data. Veeva will also share TMF trends across studies that can inform decision-making.

Senior Product Manager, Veeva eTMF

Manager, Customer Success, Clinical Operations
Discussion: Strategies to Improve Site Collaboration (Repeat Session)
More than 70% of total documents by volume in the TMF come from sites. Discuss strategies to improve site collaboration and TMF planning.

Senior Director, Clinical Operations Strategy

Senior Director, Clinical Operations Strategy
Biotech Panel: Unifying Clinical Processes and Teams with TMF
TMF experts from Biomea Fusion and Dren Bio share lessons learned about working cross-functionally and creatively solving challenges, all with lean teams and small budgets. Hear about their latest inspection experiences, methods of influencing users and stakeholders, and strategies for driving real-time TMF completeness.

Associate Director, Clinical Records Management (TMF)

Senior Manager, TMF Operations