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

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!

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.