Agenda

9:00 AM — Registration & Networking

10:00 AM — Opening Remarks

10:15 AM — Industry Trends: M&A, In-Licensing, Business Impacts & Company Strategies

11:00 AM — CDISC V1, ICH E6(R3) & TMF Impact

11:45 AM — TMF and M&A: Experiences and Case Studies

12:15 PM — Tech Innovation Spotlight: eTMF Automation with Inspection Readiness Flags & Risk Management

12:45 PM — LUNCH

1:45 PM — AI Applications, Drug Discovery, and Clinical Development

2:15 PM — Quality Management and Risk-Based Oversight

2:45 PM — Tech Innovation Spotlight: CTMS Hyper-Automation and Integration

3:05 PM — COFFEE BREAK

3:25 PM — Inspection War Stories

4:10 PM — OpTImizing eTMF Usage: Configurations, Essential Features, and Interoperability

4:50 PM — Closing Remarks

9:00 AM — Sponsor/CRO Collaboration & Technology: Best Practices, Metrics, and Resource Models

10:00 AM — Tech Innovation Spotlight: Country Workflows and SSU

10:20 AM — Powering Site Partnerships Through Collaboration and Tech

11:05 AM — TMF Closeout: Accountability, Reconciliation and Archiving

11:35 AM — AI Continuous Compliance + EDLs (eTMF Time Machine)

11:55 AM — Expectations for 2027 and Beyond

12:25 PM — LUNCH

1:30 PM — Product Roadmap Updates

2:30 PM — Trial Interactive Focus Groups

4:00 PM — Networking & 1:1 Meetings