Conference Schedule

With ongoing restructuring, teams must quickly adapt to change while maintaining efficiency. How can you navigate change control effectively, and what strategies ensure these transitions are managed seamlessly?

  • Examine how recent regulatory shifts impacted change control processes
  • Analyze how different companies navigate change management
  • Recognize the importance of being able to quickly adapt to change
Panelists:

Being inspection-ready at all times means ensuring that all documents are complete, well-organized, and fully compliant with GCP guidelines. In 2024, the FDA Compliance Program Manual introduced updated instructions for inspections—does your team have the right processes in place to meet these evolving requirements?

  • Learn from past mistakes in inspections
  • Review the updates from the FDA Compliance Program Manual
  • Navigate each stage of inspection
Panelists:

In centralized monitoring, organizations can either manage the system in-house or outsource it, each offering distinct benefits and challenges. Determining the best fit for your company requires careful evaluation of resources, expertise, and regulatory considerations. How can your team assess the right model and ensure a smooth transition?

  • Address the challenges associated with centralized monitoring
  • Compare outsourcing and in-house monitoring
  • Assess how to shift between models
Speaker:

ICH E6(R3) discusses the latest expectations for good clinical practice. One of the biggest changes is the switch from QTLs to “acceptable ranges.” Is your team ready to address these new expectations?

  • Clarify differences between ICH E6(R2) and E6(R3)
  • Debate the value of ranges vs QTLs
  • Discuss how ICH E6(R3) will impact future trials
Panelists:

Audit trail review ensures the quality and integrity of reported data. FDA guidelines emphasize risk-based approaches — is your team meeting expectations?

  • Clarify how to set up an audit trail review
  • Examine how these new steps can benefit your company
  • Determine how to gauge and improve your internal processes
Speaker:

Achieving world-class GCP compliance demands a culture of operational excellence. How can you embed continuous improvement principles into your quality program?

  • Apply operational metrics to improve GCP compliance
  • Implement continuous improvement techniques
  • Create a sustainable, quality-driven organization
Speaker:

Evolving science, tools, and regulatory expectations require a shift in vendor and site quality strategies. How can your team adapt and lead the change?

  • Review past vendor/site quality approaches
  • Analyze new trends in oversight
  • Explore tools and implementation strategies
Speaker:

As industry moves away from 100% SDV to RBM, its true impact on data quality is being questioned. Does SDV meaningfully influence outcomes?

  • Discuss inspection results related to SDV
  • Evaluate ROI of SDV
  • Debate SDV’s impact on data integrity
Panelists:

Day 1 Concludes

The RBQM framework provides the structure needed to implement risk-based practices across the clinical trial lifecycle. How can you elevate your framework to meet sponsor and regulatory expectations?

  • Understand the key components of a successful RBQM framework
  • Align RBQM with regulatory expectations
  • Overcome challenges to RBQM adoption
Speaker:

Today’s oversight professionals must analyze structured and unstructured data. Do you have the infrastructure to transform raw signals into actionable decisions?

  • Use KPIs to guide your RBQM program
  • Understand what tools to use for risk detection
  • Overcome challenges of technology integration
Panelists:

As regulators encourage the adoption of decentralized trials, sponsors and sites must adapt to new procedures for consent, data collection, and monitoring. Is your DCT model aligned with the latest guidance?

  • Understand the FDA’s 2023 draft guidance on DCTs
  • Examine the benefits and risks of DCT models
  • Ensure patient safety and data integrity in DCTs
Panelists:

Conference Concludes

 

 

 

 

 

 

 

I Accept