- Evolution of Agentic AI in clinical trials
- A framework to select the right use cases to implement Agentic AI
- Practical examples of building agentic AI use cases across clinical development
- Deep dive into AI implementation around RTSM activities
Archives: Agenda
Enhancing trial resilience and success by forging strong relationships through common goals, from a clinical supply perspective
- Leveraging insights of human dynamics to deliver IMP to clinical trials.
- Exploring how Clinical Supply Professionals can reinforce a common goal and collaboration that can break down silos.
- Bridging the gap between clinical supply, CMC, quality, regulatory, clinical operations and other stakeholders.
- Utilizing robust relationships to navigate challenges and enhance trial success.
Panel Discussion: Reviewing geopolitical impact on supply chain: minimizing disruption through effective risk mitigation planning
- Identifying latest geopolitical challenges and impact on supply chain
- Building contingency protocols from the start of trial to be better prepared for the unexpected
- Incorporating risk assessment into project management plans
Morning refreshments and networking sponsored by Hiro
Afternoon refreshments, networking and prize draw
Chairperson’s closing remarks
Sharing challenges and best practice in cell therapy trials from a small biotech perspective
- Setting up a local trial in Sweden: considerations and actions
- Communicating with multiple stakeholders
- Considering logistical requirements for personalized cell therapy: manufacturing, sites and patients
- Providing a small company perspective on cell therapy trial execution
Fireside Chat: Discussing insights on use of Real World Evidence within clinical trials
- Integrating RWE into clinical trial design
- Using RWE to enhance or compliment traditional evidence generation
- Sharing successes and lessons learned
Strong safety, lean teams: Practical pharmacovigilance strategies for biotech and pharma (Stream A room onsite)
- Understand how pharmacovigilance roles and responsibilities align across sponsors, CROs, vendors, and investigators, and why clear roles prevent inefficiencies and issues
- Learn how biotech and specialty pharma can develop scalable pharmacovigilance strategies that adapt to dynamic pipelines
- Discover how hybrid outsourcing balances in-house oversight with external expertise for global coverage
- Explore methods to enhance partnerships so pharmacovigilance can support both compliance and operational delivery
- Recognize how a well-designed pharmacovigilance model can accelerate progress from early development to marketing approval
1,000 Trials: A decade later – what’s worked, what’s new, and what’s next in RTSM?
From IVRS to RTSM: a decade of evolution, innovation, and lessons learned
- Insights from 1,000 studies: what we have consistently seen, what has worked (and hasn’t)
- Emerging trends and innovations shaping the next generation of RTSM
- What sponsors are asking for: future expectations from RTSM providers