Events

Upcoming Events

Clinical Trial Innovation Summit

Date: May 13–15, 2019
Location: Boston, MA

Session Title: Connecting CAPA Preventative Actions to Quality Risk Management to Reduce Systemic-Level Risks on New and Ongoing Studies

Session Information:

  • Explore the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH E6 (R2)
  • Discuss the importance of documentation of CAPA Action Plans and Quality Management decisions and actions
  • Describe resources developed by an industry consortium that support CAPA Management and Quality Risk Management

Session Participation: Linda B Sullivan MBA Executive Director, Metrics Champion Consortium

 

Session Title: Using Site Contracting Performance Metrics in Site Selection—Do You Have Access to the Right Data to Understand How the Site Performed?

Session Information:

  • Explore why site contracting cycle times vary by country
  • Discuss approaches organizations are using to reduce cycle time results
  • Review the data your organization should be reviewing to gain insights about which sites perform well in the context of local regulatory and ethical review requirements

Session Participation: Linda B Sullivan MBA Executive Director, Metrics Champion Consortium

European Clinical Trials Inspection Readiness Summit

Date: May 16–17, 2019
Location: London, UK

Session Title: Building the Gap Between CAPA and Quality Risk Management to Prevent Systemic-Level Issues

Session Information:

  • Examine the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH E6 (R2)
  • Explore toolkits developed by an industry consortium that support Quality Risk Management and align with inspector expectations
  • Discuss the importance of documentation of Quality Management decisions and actions for inspection readiness and approaches to achieve this

Session Participation: Keith Dorricott, Ambassador, Metrics Champion Consortium

DIA Annual Meeting

Date: Tuesday, June 25 • 10:30am – 11:30am
Location: San Diego, CA

Session Title: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
Session Information: This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6 (R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring.

Moderator: Linda B Sullivan, MBA Executive Director, Metrics Champion Consortium

Panelists:
Suzanne Lukac
Senior Account Director, CluePoints

Ann McCabe
Director, Process Excellence and Risk Management, Daiichi Sankyo Inc

Sherry Merrifield
Senior Director, Global Operations Management, Syneos Health

View Archives