- 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.
Archives: Agenda
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
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
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
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
Fireside Chat: Integrating both clinical supply and clinical team perspectives for end to end supply chain efficiency
- Optimising supply chain demand forecasting to minimise waste
- Considering AI, tools and technologies to assist in end to end supply chain planning, management and visibility
- Creating a more joined up approach through communication with clinical teams
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