Agenda

With her captivating presence and insightful perspective, hear Katie Doble's profound first-hand account of navigating clinical trials as a patient, preserving hope amidst daunting challenges, embracing humor, and the invaluable role of a supportive caregiver team

Ensuring Adaptability and High-Quality Amidst an Evolving Clinical Trial Landscape

Join us for a compelling panel discussion on resilience as the bedrock of sustainability in clinical trials. In an ever-evolving industry, maintaining adaptability and high-quality standards is crucial. We will delve into what resilience and sustainability mean to different stakeholders, including Sponsors, Providers, Sites, Participants and Regulatory bodies. Discover how robust foundations today enable future success and sustainability in clinical trials.

Key discussion points will include:

• Applying risk proportionality and adopting Quality by Design (QbD) principles to build quality into clinical trials from the ground up.
• Continuing to innovate despite some initiatives not meeting expectations.
• Understanding patient perspectives on resiliency.
• The importance of sustainability for both the planet and clinical trials.

Commitment to Transparency and Collaboration Across Stakeholders

Join us for an insightful panel discussion on integrity as the horizon of trust in clinical trials. This session will explore the vital role of transparency and collaboration in building and maintaining trust with trial participants, regulatory bodies, and other stakeholders. Emphasizing the strategic priority of maintaining open and honest communication, our panel will discuss how effective stakeholder engagement is key to ensuring the credibility and success of clinical research. Leveraging the learnings from previous sessions on wisdom, efficiency, and resilience, our experts will integrate these themes into the discourse on integrity to provide a comprehensive view. We will explore strategies for fostering meaningful collaboration and clear communication channels among all parties involved in clinical trials.

Key discussion points will include:

• The role of transparency and open communication in fostering trust.
• Strategies for effective collaboration across diverse stakeholder groups, including participants, regulators, and industry professionals.
• Integrating insights on wisdom, efficiency, and resilience to enhance stakeholder interactions.
• Case studies demonstrating successful stakeholder engagement and trust-building.

The Intersection of E8(R1) and E6(R3) and Practical Solutions to Drive Efficient Implementation and Change Management

ICH E6(R3) Good Clinical Practice builds on the key concepts in ICH E8(R1) General Considerations for Clinical Studies. With E6(R3) imminent implementation timelines, join us for an informative discussion where we will highlight how these two important guidance documents together enhance quality and efficiency in clinical trials. Additionally, we will outline practical strategies to support efficient implementation at your organization. 

Key Discussion Points: 

• Integration of E6(R3) with E8(R1) to enhance trial quality and efficiency 
• Practical strategies for efficient implementation 
• Best practices for aligning organizational processes with new guidelines 

Charting Successful Inspections: The Role of Collaboration and Partnership between Sites and Sponsors in Evidencing Trial Control in a Risk Proportionate Landscape

In a dynamic regulatory environment, effective trial control and risk management are paramount to the success of clinical inspections. Join us for this engaging workshop where we will highlight the pivotal role of collaboration between Sites and Sponsors in achieving compliance and evidencing trial control. 

Key Discussion Points: 

• Collaborative Strategies for Inspection Readiness. 
• Risk Proportionate Management and Oversight. 
• Essential Record Identification and Management. 
• Evidencing Trial Control to Drive Success.