Apple Prize Draw taking place in exhibition room – please ensure your cards are stamped and submitted by 1:15pm
Archives: Agenda
Afternoon break, networking and prize draw
Running decentralized rare disease trials: challenges and benefits
- Comparing outcomes of a DCT model versus non DCT model
- Sharing benefits and lessons learned from experiences within rare disease DCTs
Fireside Chat: Navigating FDA policy & politics in rare disease drug development under the Trump Administration
Rare disease innovation has always required both scientific courage and regulatory flexibility. Today, under the Trump Administration’s FDA, sponsors are seeing new opportunities for accelerated approvals, digital biomarkers, and innovative endpoints—but also greater scrutiny around confirmatory trials and uncertainty over key incentives like the pediatric voucher program. Meanwhile, political turbulence at FDA and CDC leadership levels underscores just how intertwined policy and science have become.
Interactive Session: Maximizing Site Engagement: A Sponsor’s Perspective in the Evolving Clinical Trial Landscape
| · Understanding Site Needs: Aligning sponsor strategies with site capabilities and expectations
· Building Trust and Transparency: Fostering long-term partnerships through clear communication and support · Technology & Tools: Leveraging digital platforms to enhance site-sponsor collaboration · Metrics That Matter: Defining and tracking meaningful engagement KPIs for sustained success |
Chairperson’s closing remarks
Chairperson’s closing remarks
Delivering research in NHS hospitals: the new NIHR Research Delivery Network (RDN)
- The new NIHR RDN landscape
- Delivering research in hospital settings
- Research delivery in partnership
FIRESIDE CHAT: Leveraging Process Improvements as Strategic Assets
| · Corporate Anthropology as the basis for process innovation and optimisation
· Viewing Process Innovation as Strategic Assets · Communities of Practice as vehicles for process innovation and implementing optimal ways of working · Process Innovation within highly regulated SOP driven environments |
PANEL DISCUSSION: Unravelling the impact of ICH E6 Revision 3: implementing new standards in good clinical practice
ICH E6 (R3) introduces significant updates to Good Clinical Practice guidelines, emphasizing risk-based quality management, patient centricity, and flexibility in trial design and execution. This panel discussion will address the impact of ICH E6 (R3) on clinical trials, comparing it to the previous ICH E6 (R2), discussing approaches to implementation, and considering varied interpretations among stakeholders.
- Understand the key changes in ICH E6 (R3) and their implications for clinical trial conduct
- Explore different approaches to implementing the new guidelines in diverse trial settings
- Analyse the challenges, opportunities, and interpretations associated with ICH E6 (R3)
- Highlight meaningful differences between ICH E6 (R2) and ICH E6 (R3) and their practical impacts