Archives: Agenda

What’s Next in Data & Risk Management? Evolving Regulatory Guidance, AI, and the Future of Integrated Oversight

  • Exploring the emerging trends shaping the future of RBQM, from evolving guidance on risk, quality, and sponsor oversight, including ICH E6(R3) and ICH E8(R1)
  • Examining FDA’s emerging risk-based framework for the use of AI in support of regulatory decision-making
  • Considering how AI and integrated analytics can strengthen oversight and decision-making across trials and partners
  • Understanding how connected data and platforms can reduce fragmentation and support more consistent, scalable, future-ready oversight strategies

PRIZE DRAW

Sponsored by Dr. Vince Clinical Research

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

Entries from this prize draw will also be entered into the early birds prize draw at 8.20am on day 2, you must be present to win!

KEYNOTE: The Value of Culture: A Strategic Asset

  • Embedding a strong internal culture to drive consistent execution, accountability, and scientific rigor across cross-functional clinical teams
  • Extending cultural alignment beyond the organization to CROs, labs, and technology partners to enable more effective collaboration and shared ownership
  • Improving communication, escalation pathways, and transparency to identify and manage risks earlier in complex, outsourced trial environments
  • Accelerating decision-making by aligning expectations, behaviors, and governance across global clinical programs
  • Reducing operational friction and delays by proactively addressing cultural misalignment and reinforcing shared ways of working

CASE STUDY Founder Perspective: What Clinical Operations Looks Like When You’re Building an Entirely New Therapeutic Platform

  • When there’s no playbook: Navigating clinical development for a first-of-its-kind therapeutic platform.
  • Building the roadmap without getting lost: Making decisions when established endpoints, biomarkers, assays, and development pathways don’t fully apply.
  • What founders learn the hard way: Practical lessons, unexpected bottlenecks, and decisions that look very different from inside an emerging biotech.
  • AI as a force multiplier: Using AI to accelerate decisions, insights, and execution across clinical development.
  • The founder as an orchestrator: Connecting science, CMC, regulatory, clinical, manufacturing, and business decisions when organizational boundaries are still forming.